Cordis Corporation
Industry: Company
DescriptionCordis develops and manufactures medical devices for diagnostics and interventional procedures to treat patients suffering from coronary and peripheral vascular diseases. Cordis was founded in 1959 in Miami, Florida and currently operates in North America, EMEA, Asia-Pacific and Latin America markets. Headquarters: Hialeah, FL Founder: William P. Murphy Jr. Founded: 1957 Parent organization: Cardinal Health Subsidiaries: Cordis Cardiology, Ensure Medical, Inc., Biologics Delivery Systems Group, Cordis Neurovascular, Inc.
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Cordis Corporation Employees
Employee
Years
Job
Industry
Nelson Suarez Nelson Suarez's Cordis Corporation Experience January 1985 - January 1992
Job Health Safety Enviromental Compliance Administrator at Lightning Master Corporation
Industry Oil & Energy
Experience
Lightning Master Corporation June 2014 - Present
York Risk Services Group November 2013 - June 2014
Seminole Electric Cooperative March 2012 - November 2013
Arthur J. Gallagher & Co. May 2011 - March 2012
Mitsubishi Power Systems Americas June 2010 - June 2011
Cordis January 1992 - January 2010
Cordis Corporation January 1985 - January 1992
Skills
EHS, Occupational Health, Risk Assessment, ISO 14001, Accident Investigation, Hazard Analysis, Root Cause Analysis, First Responder, Emergency Management, Fire Safety, Quality System, Auditing, Manufacturing, Training, Inspection, Hazard Recognition, Hazardous Materials, Safety Management..., Ergonomics, HAZWOPER, Quality Auditing, Environmental Awareness, Construction Safety, Environmental Compliance, Leadership, Behavior Based Safety, Process Improvement, Safety Training, Incident Investigation, Program Management, Continuous Improvement, Six Sigma, Safety Leadership, Safety Audits, Facilities Management, Workplace Safety, Risk Management, Policy, Industrial Safety, Project Planning, Hazardous Waste..., Waste Management, Safety Management, Emergency Operations, Supervisory Skills, Software Documentation, Safety Auditing, Coordination, Investigation, Crisis Management
Education
Columbia Southern University 2013 — 2015
I'm in the process of completing coursework toward Bachelor of Science, Occupational Safety & Health, 3.52
Columbia Southern University 2010 — 2013
AAS Associate of Applied Science, Fire Science, 3.5 2 GPA
Broward Community College Fire Science Dept 2008 — 2008
Fire Inspector One, Associate in Science Degree in Fire Science Technology
GEORGE T. BAKER AVIATION TECHNICAL SCHOOL 1973 — 1977
Aviation Maintenance Professional - AMP, Non-Destructive Testing Training
MIAMI SENIOR HIGH SCHOOL - SOUTHWEST MIAMI HIGH SCHOOL 1973 — 1977
High School, General Studies
Lightning Master Corporation June 2014 - Present
York Risk Services Group November 2013 - June 2014
Seminole Electric Cooperative March 2012 - November 2013
Arthur J. Gallagher & Co. May 2011 - March 2012
Mitsubishi Power Systems Americas June 2010 - June 2011
Cordis January 1992 - January 2010
Cordis Corporation January 1985 - January 1992
Skills
EHS, Occupational Health, Risk Assessment, ISO 14001, Accident Investigation, Hazard Analysis, Root Cause Analysis, First Responder, Emergency Management, Fire Safety, Quality System, Auditing, Manufacturing, Training, Inspection, Hazard Recognition, Hazardous Materials, Safety Management..., Ergonomics, HAZWOPER, Quality Auditing, Environmental Awareness, Construction Safety, Environmental Compliance, Leadership, Behavior Based Safety, Process Improvement, Safety Training, Incident Investigation, Program Management, Continuous Improvement, Six Sigma, Safety Leadership, Safety Audits, Facilities Management, Workplace Safety, Risk Management, Policy, Industrial Safety, Project Planning, Hazardous Waste..., Waste Management, Safety Management, Emergency Operations, Supervisory Skills, Software Documentation, Safety Auditing, Coordination, Investigation, Crisis Management
Education
Columbia Southern University 2013 — 2015
I'm in the process of completing coursework toward Bachelor of Science, Occupational Safety & Health, 3.52
Columbia Southern University 2010 — 2013
AAS Associate of Applied Science, Fire Science, 3.5 2 GPA
Broward Community College Fire Science Dept 2008 — 2008
Fire Inspector One, Associate in Science Degree in Fire Science Technology
GEORGE T. BAKER AVIATION TECHNICAL SCHOOL 1973 — 1977
Aviation Maintenance Professional - AMP, Non-Destructive Testing Training
MIAMI SENIOR HIGH SCHOOL - SOUTHWEST MIAMI HIGH SCHOOL 1973 — 1977
High School, General Studies
Georgia Pallet Georgia Pallet's Cordis Corporation Experience June 1979 - December 1989
Job Administrative Assistant at FedEx Express
Industry Package/Freight Delivery
Experience
FedEx Express April 2004 - Present
Intermarket July 2001 - April 2004
Ryder System, Inc. 1994 - 2000
KFC Int'l February 1990 - December 1992
Cordis Corporation June 1979 - December 1989
Skills
Customer Service, Data Entry, Logistics, Administrative..., Outlook, Supply Chain Management, Shipping, Process Scheduler, Team Building, Transportation, Invoicing, Administrative..., Operations Management, Management, Supply Chain, Cross-functional Team..., Strategic Planning, Process Improvement
Education
Florida International University 2012 — 2014
Bachelor of Science (B.S.), Liberal Arts and Sciences, General Studies and Humanities
Miami Dade College
Associate of Arts and Sciences (A.A.S.), Business Administration and Management, General
FedEx Express April 2004 - Present
Intermarket July 2001 - April 2004
Ryder System, Inc. 1994 - 2000
KFC Int'l February 1990 - December 1992
Cordis Corporation June 1979 - December 1989
Skills
Customer Service, Data Entry, Logistics, Administrative..., Outlook, Supply Chain Management, Shipping, Process Scheduler, Team Building, Transportation, Invoicing, Administrative..., Operations Management, Management, Supply Chain, Cross-functional Team..., Strategic Planning, Process Improvement
Education
Florida International University 2012 — 2014
Bachelor of Science (B.S.), Liberal Arts and Sciences, General Studies and Humanities
Miami Dade College
Associate of Arts and Sciences (A.A.S.), Business Administration and Management, General
Julie Patskin Julie Patskin's Cordis Corporation Experience 1991 - 1995
Job Director, Complaint Management Strategy; Change, Communication & Training Lead at Johnson & Johnson
Industry Medical Devices
Experience
Johnson & Johnson Medical Devices & Diagnostics July 2013 - Present
Cordis September 2012 - June 2013
Cordis / Johnson & Johnson January 2009 - August 2012
Cordis February 2005 - December 2008
Cordis December 1999 - January 2005
Cordis January 1999 - November 1999
Cordis June 1997 - January 1999
Cordis October 1996 - May 1997
Cordis February 1995 - October 1996
Cordis Corporation 1991 - 1995
Skills
Customer Oriented, Cross-functional Team..., Six Sigma, Communicator, Program Management, Management, Project Management, Thinking Outside The Box, Organizational..., Problem Solving, Workshop Facilitation, Medical Devices, Inspiration, Change Management, Leadership, FDA, Product Launch, PMP, DMAIC, Product Development, Healthcare, Product Marketing, Strategic Planning, Process Improvement, Continuous Improvement, Training, Manufacturing, Sales, SAP, Product Management, Instructor-led Training, Hands-on Training, Employee Training, Team Building, Sales Administration, Customer Centric..., Budgets, Business Process, Sales Management, Market Research, Business Analysis, Strategy, Sales Operations, Business Process..., SDLC, Pricing
Education
University of Miami 1985 — 1988
Masters of Business Administration, Marketing
City University of New York-Brooklyn College 1976 — 1982
Bachelor of Arts, Public Communication
Far Rockaway High School
Johnson & Johnson Medical Devices & Diagnostics July 2013 - Present
Cordis September 2012 - June 2013
Cordis / Johnson & Johnson January 2009 - August 2012
Cordis February 2005 - December 2008
Cordis December 1999 - January 2005
Cordis January 1999 - November 1999
Cordis June 1997 - January 1999
Cordis October 1996 - May 1997
Cordis February 1995 - October 1996
Cordis Corporation 1991 - 1995
Skills
Customer Oriented, Cross-functional Team..., Six Sigma, Communicator, Program Management, Management, Project Management, Thinking Outside The Box, Organizational..., Problem Solving, Workshop Facilitation, Medical Devices, Inspiration, Change Management, Leadership, FDA, Product Launch, PMP, DMAIC, Product Development, Healthcare, Product Marketing, Strategic Planning, Process Improvement, Continuous Improvement, Training, Manufacturing, Sales, SAP, Product Management, Instructor-led Training, Hands-on Training, Employee Training, Team Building, Sales Administration, Customer Centric..., Budgets, Business Process, Sales Management, Market Research, Business Analysis, Strategy, Sales Operations, Business Process..., SDLC, Pricing
Education
University of Miami 1985 — 1988
Masters of Business Administration, Marketing
City University of New York-Brooklyn College 1976 — 1982
Bachelor of Arts, Public Communication
Far Rockaway High School
Paul Grazal Paul Grazal's Cordis Corporation Experience October 2004 - Present
Job Category Manager Packaging. Johnson & Johnson
Industry Medical Devices
Experience
Johnson & Johnson May 2015 - Present
Cordis Corporation October 2004 - Present
Trane January 2003 - October 2004
Black & Decker HHI August 2000 - January 2003
American Airlines January 1996 - August 2000
Container Testing Laboratory August 1992 - December 1995
Skills
Supply Chain, Strategic Sourcing, Manufacturing, Procurement, Packaging Design, Strategic Negotiations, Business Strategy, Packaging, Strategy, Contract Negotiation, Sourcing, Supply Chain Management, Product Management, Management, Leadership, Engineering, Negotiation, Cross-functional Team..., Six Sigma, Continuous Improvement
Education
Michigan State University 1986 — 1991
Bachelor of Science, Packaging
Johnson & Johnson May 2015 - Present
Cordis Corporation October 2004 - Present
Trane January 2003 - October 2004
Black & Decker HHI August 2000 - January 2003
American Airlines January 1996 - August 2000
Container Testing Laboratory August 1992 - December 1995
Skills
Supply Chain, Strategic Sourcing, Manufacturing, Procurement, Packaging Design, Strategic Negotiations, Business Strategy, Packaging, Strategy, Contract Negotiation, Sourcing, Supply Chain Management, Product Management, Management, Leadership, Engineering, Negotiation, Cross-functional Team..., Six Sigma, Continuous Improvement
Education
Michigan State University 1986 — 1991
Bachelor of Science, Packaging
Lisbert Avila-Yu Lisbert Avila-Yu's Cordis Corporation Experience 2001 - 2010
Job Associate Director of Regulatory Affairs at HeartWare Inc.
Industry Medical Devices
Experience
HeartWare Inc. March 2014 - Present
HeartWare Inc April 2010 - March 2014
RAPS Annual Conference 2013 - 2013
Cordis Corporation 2001 - 2010
Duke University 1999 - 2000
Skills
Design Control, ISO 13485, ICH-GCP, Hospitals, FDA, Biotechnology, Medical Devices, Regulatory Affairs, CAPA, Quality System, Regulatory Submissions, V&V, ISO 14971, Validation, GMP, Change Control, 21 CFR, 21 CFR Part 11, Biomedical Engineering, FDA GMP, Medical Device Directive, CE marking, CQA, Regulatory Requirements
Education
Duke University 1996 — 2000
Miami Springs Senior High School
HeartWare Inc. March 2014 - Present
HeartWare Inc April 2010 - March 2014
RAPS Annual Conference 2013 - 2013
Cordis Corporation 2001 - 2010
Duke University 1999 - 2000
Skills
Design Control, ISO 13485, ICH-GCP, Hospitals, FDA, Biotechnology, Medical Devices, Regulatory Affairs, CAPA, Quality System, Regulatory Submissions, V&V, ISO 14971, Validation, GMP, Change Control, 21 CFR, 21 CFR Part 11, Biomedical Engineering, FDA GMP, Medical Device Directive, CE marking, CQA, Regulatory Requirements
Education
Duke University 1996 — 2000
Miami Springs Senior High School
Susan McCorkle Susan McCorkle's Cordis Corporation Experience October 2000 - April 2005
Job Medical Devices Professional
Industry Medical Devices
Experience
Abbott March 2010 - August 2012
ev3 April 2005 - October 2009
CORDIS CORPORATION October 2000 - April 2005
RADIOTHERAPEAUTICS October 1999 - October 2000
U.S. SURGICAL / TYCO November 1995 - October 1999
Skills
Capital Equipment, Vascular, Surgery, Nursing, Medical Sales, Cardiology, Interventional Radiology, Surgeons, Disposables, Vascular Surgery, Neurology, Oncology, Operating Room, Sales Operations, Interventional..., Market Development, Medical Devices
Education
Marist College
Master of Business Administration
Marist College 1989 — 1993
Bachelor of Science, business administration/finance
Abbott March 2010 - August 2012
ev3 April 2005 - October 2009
CORDIS CORPORATION October 2000 - April 2005
RADIOTHERAPEAUTICS October 1999 - October 2000
U.S. SURGICAL / TYCO November 1995 - October 1999
Skills
Capital Equipment, Vascular, Surgery, Nursing, Medical Sales, Cardiology, Interventional Radiology, Surgeons, Disposables, Vascular Surgery, Neurology, Oncology, Operating Room, Sales Operations, Interventional..., Market Development, Medical Devices
Education
Marist College
Master of Business Administration
Marist College 1989 — 1993
Bachelor of Science, business administration/finance
Alfonso Raul Alfonso Raul's Cordis Corporation Experience March 1985 - March 2004
Job Campus Facilities Planner at Miami Dade College
Industry Higher Education
Experience
Miami Dade College November 2004 - Present
Cordis Corporation March 1985 - March 2004
Johnson & Johnson 1985 - 2004
Skills
Biomedical Engineering, Minitab, Data Analysis, Statistics, Healthcare, Medical Devices, Clinical Research, Microsoft Office, Microscopy, Chemistry, Science, Lifesciences, Experimentation, Research, Immunology
Education
Florida International University 2000 — 2006
Bachelor's degree, Construction Management
FIU
Bachelor's degree
Miami Dade College November 2004 - Present
Cordis Corporation March 1985 - March 2004
Johnson & Johnson 1985 - 2004
Skills
Biomedical Engineering, Minitab, Data Analysis, Statistics, Healthcare, Medical Devices, Clinical Research, Microsoft Office, Microscopy, Chemistry, Science, Lifesciences, Experimentation, Research, Immunology
Education
Florida International University 2000 — 2006
Bachelor's degree, Construction Management
FIU
Bachelor's degree
Gabriella Dahlgren Gabriella Dahlgren's Cordis Corporation Experience October 2005 - April 2009
Job Manager, Analytical Sciences and Technology at The Janssen Pharmaceutical Companies of Johnson & Johnson
Industry Medical Devices
Experience
The Janssen Pharmaceutical Companies of Johnson & Johnson April 2015 - Present
LifeCell Corporation August 2011 - April 2015
Cordis April 2009 - August 2011
Cordis Corporation October 2005 - April 2009
University of Michigan August 2004 - September 2005
University of Michigan June 2001 - August 2004
University of Florida August 1999 - June 2001
Southeastern Louisiana University 1995 - 1999
Skills
HPLC, Six Sigma, Methods Development, Analytical Chemistry, LC-MS, UV-Vis, Chromatography, Gas Chromatography, Chemistry, Validation, UV/Vis, FDA, V&V, GMP, CAPA, R&D, Drug Delivery
Education
University of Michigan 2001 — 2004
PhD, Analytical Chemistry
University of Florida 1999 — 2002
Southeastern Louisiana University 1995 — 1999
Bachelor, Chemistry, Summa Cum Laude
The Janssen Pharmaceutical Companies of Johnson & Johnson April 2015 - Present
LifeCell Corporation August 2011 - April 2015
Cordis April 2009 - August 2011
Cordis Corporation October 2005 - April 2009
University of Michigan August 2004 - September 2005
University of Michigan June 2001 - August 2004
University of Florida August 1999 - June 2001
Southeastern Louisiana University 1995 - 1999
Skills
HPLC, Six Sigma, Methods Development, Analytical Chemistry, LC-MS, UV-Vis, Chromatography, Gas Chromatography, Chemistry, Validation, UV/Vis, FDA, V&V, GMP, CAPA, R&D, Drug Delivery
Education
University of Michigan 2001 — 2004
PhD, Analytical Chemistry
University of Florida 1999 — 2002
Southeastern Louisiana University 1995 — 1999
Bachelor, Chemistry, Summa Cum Laude
Mira (Sullivan) Leiwant's Cordis Corporation Experience January 2008 - December 2008
Job Director Quality Engineering and Regulatory Affairs at LifeCell Corporation
Industry Medical Devices
Experience
Acelity March 2013 - Present
LifeCell Corporation March 2013 - April 2014
Svelte Medical Systems March 2011 - March 2013
Vascular Therapies March 2009 - February 2011
Micell Technologies 2010 - 2011
Cordis Corporation January 2008 - December 2008
Cordis Corporation, a Johnson and Johnson company September 2007 - December 2007
Cordis, a Johnson and Johnson company October 2005 - August 2007
Cordis March 2003 - October 2005
Cordis June 2001 - March 2003
Skills
FDA, Medical Devices, Design Control, Quality Assurance, ISO 13485, Sop, Auditing, V&V, 21 CFR Part 11, Quality Control, Quality System, CAPA, GLP, Lean Manufacturing, Validation, Product Development, Change Control, GMP
Education
Cornell University 1997 — 1998
Master of Engineering
Cornell University 1994 — 1997
Bachelor of Science
Acelity March 2013 - Present
LifeCell Corporation March 2013 - April 2014
Svelte Medical Systems March 2011 - March 2013
Vascular Therapies March 2009 - February 2011
Micell Technologies 2010 - 2011
Cordis Corporation January 2008 - December 2008
Cordis Corporation, a Johnson and Johnson company September 2007 - December 2007
Cordis, a Johnson and Johnson company October 2005 - August 2007
Cordis March 2003 - October 2005
Cordis June 2001 - March 2003
Skills
FDA, Medical Devices, Design Control, Quality Assurance, ISO 13485, Sop, Auditing, V&V, 21 CFR Part 11, Quality Control, Quality System, CAPA, GLP, Lean Manufacturing, Validation, Product Development, Change Control, GMP
Education
Cornell University 1997 — 1998
Master of Engineering
Cornell University 1994 — 1997
Bachelor of Science
Mark Milward, MBA, LBB, MBB Mark Milward, MBA, LBB, MBB's Cordis Corporation Experience December 1985 - May 1988
Job Master Black Belt at US Navy (Department of Defense)
Industry Mechanical or Industrial Engineering
Experience
US Navy (Department of Defense) February 2011 - Present
Milward & Associates September 2001 - Present
Mainstream GS October 2010 - January 2011
National Graduate School of Quality Management June 2009 - December 2009
United Technologies Incorporated, Pratt & Whitney & Hamilton Sundstrand February 2004 - November 2008
ROCKWELL-COLLINS October 1997 - February 2002
MILWARD & ASSOCIATES May 1988 - October 1997
CORDIS CORPORATION December 1985 - May 1988
Skills
Six Sigma, Lean Manufacturing, Strategic Planning, Process Improvement, Value Stream Mapping, Project Management, Root Cause Analysis, Black Belt, Strategy, SPC, Leadership, Continuous Improvement, Program Management, Quality System, Green Belt, Manufacturing, Business Process..., DMAIC, TQM, Manufacturing..., Analysis, Aerospace, Quality Control, Quality Assurance, Cross-functional Team..., Training, Process Engineering, Operational Excellence, Kaizen, Quality Management, 5S, PMP, Management, Operations Management, Supply Chain Management, Performance Improvement, Manufacturing..., Supply Chain, Organizational..., Theory of Constraints, Manufacturing Operations, ISO, FMEA, Industrial Engineering
Education
Barry University
BS, Manufacturing Engineering Technology
Nova Southeastern University
MBA, Business Administration
US Navy (Department of Defense) February 2011 - Present
Milward & Associates September 2001 - Present
Mainstream GS October 2010 - January 2011
National Graduate School of Quality Management June 2009 - December 2009
United Technologies Incorporated, Pratt & Whitney & Hamilton Sundstrand February 2004 - November 2008
ROCKWELL-COLLINS October 1997 - February 2002
MILWARD & ASSOCIATES May 1988 - October 1997
CORDIS CORPORATION December 1985 - May 1988
Skills
Six Sigma, Lean Manufacturing, Strategic Planning, Process Improvement, Value Stream Mapping, Project Management, Root Cause Analysis, Black Belt, Strategy, SPC, Leadership, Continuous Improvement, Program Management, Quality System, Green Belt, Manufacturing, Business Process..., DMAIC, TQM, Manufacturing..., Analysis, Aerospace, Quality Control, Quality Assurance, Cross-functional Team..., Training, Process Engineering, Operational Excellence, Kaizen, Quality Management, 5S, PMP, Management, Operations Management, Supply Chain Management, Performance Improvement, Manufacturing..., Supply Chain, Organizational..., Theory of Constraints, Manufacturing Operations, ISO, FMEA, Industrial Engineering
Education
Barry University
BS, Manufacturing Engineering Technology
Nova Southeastern University
MBA, Business Administration
Darrell Thomas Darrell Thomas's Cordis Corporation Experience June 2006 - April 2010
Job IT Project Manager at Johnson & Johnson
Industry Medical Devices
Experience
Johnson & Johnson May 2010 - Present
Cordis Corporation June 2006 - April 2010
Cordis Corporation June 2003 - May 2006
Cordis Corporation September 2002 - May 2003
Skills
Software Documentation, Project Management, Databases, Process Improvement, CRM, Management, SQL, Business Intelligence, Leadership, SDLC
Education
Florida Atlantic University 2003 — 2005
MBA
Florida State University 1998 — 2002
B.S., Management Information Systems
Johnson & Johnson May 2010 - Present
Cordis Corporation June 2006 - April 2010
Cordis Corporation June 2003 - May 2006
Cordis Corporation September 2002 - May 2003
Skills
Software Documentation, Project Management, Databases, Process Improvement, CRM, Management, SQL, Business Intelligence, Leadership, SDLC
Education
Florida Atlantic University 2003 — 2005
MBA
Florida State University 1998 — 2002
B.S., Management Information Systems
Sadhana Swarup Sadhana Swarup's Cordis Corporation Experience October 2007 - August 2011
Job Stability Equipment Coordinator at Heron Therapeutics, Inc.
Industry Pharmaceuticals
Experience
Heron Therapeutics, Inc. May 2014 - Present
Heron Therapeutics, Inc. May 2014 - Present
Affymax, Inc August 2011 - December 2012
Cordis Corporation October 2007 - August 2011
Nektar Thearapeutics March 2005 - May 2007
ALZA Corporation June 2000 - March 2004
LifeScan April 1998 - May 2000
Skills
Analytical Chemistry, GMP, Drug Delivery, HPLC, GLP, Validation, Sop, LIMS, V&V, FDA, Change Control
Education
De Anza College 1996 — 1997
Certificate of Achievement, Biotechnology
Ramnarain Ruia College, Bombay, India 1992 — 1993
Diploma, Industrial Analytical Chemistry
Kanpur University
M.Sc., Physical Chemistry
Heron Therapeutics, Inc. May 2014 - Present
Heron Therapeutics, Inc. May 2014 - Present
Affymax, Inc August 2011 - December 2012
Cordis Corporation October 2007 - August 2011
Nektar Thearapeutics March 2005 - May 2007
ALZA Corporation June 2000 - March 2004
LifeScan April 1998 - May 2000
Skills
Analytical Chemistry, GMP, Drug Delivery, HPLC, GLP, Validation, Sop, LIMS, V&V, FDA, Change Control
Education
De Anza College 1996 — 1997
Certificate of Achievement, Biotechnology
Ramnarain Ruia College, Bombay, India 1992 — 1993
Diploma, Industrial Analytical Chemistry
Kanpur University
M.Sc., Physical Chemistry
Curtis Von Gunten Curtis Von Gunten's Cordis Corporation Experience January 1982 - January 1988
Job Quest National Services North Central Florida
Industry Management Consulting
Experience
Quest National Services North Central Florida April 2013 - Present
Select Revenue Solutions January 2012 - February 2013
St. Jude Medical November 1998 - February 2008
Telectronics Pacing Systems January 1988 - January 1998
Cordis Corporation January 1982 - January 1988
Shands Teaching Hospital at the University of Florida January 1974 - January 1982
St. Alban's Naval Hospital January 1969 - January 1973
Skills
Healthcare, Program Management, Customer Service, Healthcare Management, Medical Devices, Pediatrics, Sales Management, Pacemakers, Hospitals, Microsoft Office, New Business Development, Capital Equipment, Cost Segregation..., Cardiology, Medical Billing and..., Medical Staff..., AR management, HIPAA Compliance for..., EMR, HIPAA, Management, Clinical Research, Team Building, EHR
Education
University of Florida 1975 — 1979
BS, Health Science
University of Florida
Bachelor, Health Science
Santa Fe Community College 1973 — 1975
AS, Cardiovascular technology
Revere High
Quest National Services North Central Florida April 2013 - Present
Select Revenue Solutions January 2012 - February 2013
St. Jude Medical November 1998 - February 2008
Telectronics Pacing Systems January 1988 - January 1998
Cordis Corporation January 1982 - January 1988
Shands Teaching Hospital at the University of Florida January 1974 - January 1982
St. Alban's Naval Hospital January 1969 - January 1973
Skills
Healthcare, Program Management, Customer Service, Healthcare Management, Medical Devices, Pediatrics, Sales Management, Pacemakers, Hospitals, Microsoft Office, New Business Development, Capital Equipment, Cost Segregation..., Cardiology, Medical Billing and..., Medical Staff..., AR management, HIPAA Compliance for..., EMR, HIPAA, Management, Clinical Research, Team Building, EHR
Education
University of Florida 1975 — 1979
BS, Health Science
University of Florida
Bachelor, Health Science
Santa Fe Community College 1973 — 1975
AS, Cardiovascular technology
Revere High
Juan C Fernandez Juan C Fernandez's Cordis Corporation Experience April 2004 - February 2005
Job Associate Director Technical Operations at Merck
Industry Medical Devices
Experience
Merck July 2015 - Present
MEDDEVICE Manufacturing Solutions, LLC December 2014 - July 2015
Vossen Wheels Inc. July 2014 - February 2015
Orthosensor, Inc. February 2011 - June 2014
Tridien Medical March 2010 - February 2011
Noven Pharmaceuticals, inc. June 2005 - February 2010
South Florida Manufacturer Association 2006 - 2009
VeinRx LLC February 2005 - June 2005
Cordis Corporation April 2004 - February 2005
Cordis, Johnson & Johnson 1986 - 2005
Skills
Cross-functional Team..., Six Sigma, Quality Assurance, FDA, Manufacturing, Medical Devices, Operations Management, Engineering Management, Engineering, Product Development, Lean Manufacturing, Product Launch, Process Improvement, Quality System, Leadership Development, Continuous Improvement, ISO 13485, Technical Leadership, DMAIC, Validation, CAPA, R&D, Project Management, Plant Maintenance, Strategy, Design Control, Management, Process Engineering, Leadership, Strategic Planning, GMP, Automation, V&V, Training, Business Development, Root Cause Analysis, Engineering &..., Environmental, Health,..., Program Management, Performance Management, Quality Management, Lean six sigma, Process Simulation, Design of Experiments, SPC, FMEA, Six Sigma Process..., Six Sigma Green Belt, ISO, Team Building
Education
Nova Southeastern University 1994 — 1998
BSBM, Business Management
New York Institute of Photography 1991 — 1993
AS, Professional Photography
Florida International University 1985 — 1989
BSME, Mechanical Engineering
Clinton Community College 1983 — 1984
College Preparatory Program, Mathematics, Communications, writing, reading and study skills
Merck July 2015 - Present
MEDDEVICE Manufacturing Solutions, LLC December 2014 - July 2015
Vossen Wheels Inc. July 2014 - February 2015
Orthosensor, Inc. February 2011 - June 2014
Tridien Medical March 2010 - February 2011
Noven Pharmaceuticals, inc. June 2005 - February 2010
South Florida Manufacturer Association 2006 - 2009
VeinRx LLC February 2005 - June 2005
Cordis Corporation April 2004 - February 2005
Cordis, Johnson & Johnson 1986 - 2005
Skills
Cross-functional Team..., Six Sigma, Quality Assurance, FDA, Manufacturing, Medical Devices, Operations Management, Engineering Management, Engineering, Product Development, Lean Manufacturing, Product Launch, Process Improvement, Quality System, Leadership Development, Continuous Improvement, ISO 13485, Technical Leadership, DMAIC, Validation, CAPA, R&D, Project Management, Plant Maintenance, Strategy, Design Control, Management, Process Engineering, Leadership, Strategic Planning, GMP, Automation, V&V, Training, Business Development, Root Cause Analysis, Engineering &..., Environmental, Health,..., Program Management, Performance Management, Quality Management, Lean six sigma, Process Simulation, Design of Experiments, SPC, FMEA, Six Sigma Process..., Six Sigma Green Belt, ISO, Team Building
Education
Nova Southeastern University 1994 — 1998
BSBM, Business Management
New York Institute of Photography 1991 — 1993
AS, Professional Photography
Florida International University 1985 — 1989
BSME, Mechanical Engineering
Clinton Community College 1983 — 1984
College Preparatory Program, Mathematics, Communications, writing, reading and study skills
Mike Noyes Mike Noyes's Cordis Corporation Experience June 1991 - October 1995
Job Vice President, U.S. Operations at Smiths Medical
Industry Medical Devices
Experience
Smiths Medical August 2014 - Present
Smiths Medical May 2012 - August 2014
Smiths Medical January 2011 - May 2012
Medtronic Corporation November 2005 - January 2011
Medtronic Corporation November 2004 - November 2005
Medtronic Corporation April 2002 - November 2004
Medtronic Corporation December 1998 - April 2002
Galileo Corporation July 1998 - December 1998
Tyco International October 1995 - July 1998
Cordis Corporation June 1991 - October 1995
Skills
Manufacturing, Manufacturing..., Continuous Improvement, Lean Manufacturing, Engineering, Medical Devices, FDA, Kaizen, Value Stream Mapping, Strategic Planning, GMP, Cross-functional Team..., Change Management, Operations Management, Problem Solving, Six Sigma, Commercialization, ISO, ISO 13485, Quality System, R&D, DMAIC, CAPA, Process Improvement, Design of Experiments, Root Cause Analysis, SPC, Design Control, V&V, Start-ups
Education
Columbia University in the City of New York 1996 — 1998
Master of Science, Mechanical Engineering
Nova Southeastern University 1992 — 1995
Master of Business Administration, Business
Northeastern University 1986 — 1991
Smiths Medical August 2014 - Present
Smiths Medical May 2012 - August 2014
Smiths Medical January 2011 - May 2012
Medtronic Corporation November 2005 - January 2011
Medtronic Corporation November 2004 - November 2005
Medtronic Corporation April 2002 - November 2004
Medtronic Corporation December 1998 - April 2002
Galileo Corporation July 1998 - December 1998
Tyco International October 1995 - July 1998
Cordis Corporation June 1991 - October 1995
Skills
Manufacturing, Manufacturing..., Continuous Improvement, Lean Manufacturing, Engineering, Medical Devices, FDA, Kaizen, Value Stream Mapping, Strategic Planning, GMP, Cross-functional Team..., Change Management, Operations Management, Problem Solving, Six Sigma, Commercialization, ISO, ISO 13485, Quality System, R&D, DMAIC, CAPA, Process Improvement, Design of Experiments, Root Cause Analysis, SPC, Design Control, V&V, Start-ups
Education
Columbia University in the City of New York 1996 — 1998
Master of Science, Mechanical Engineering
Nova Southeastern University 1992 — 1995
Master of Business Administration, Business
Northeastern University 1986 — 1991
Barry Yomtov Barry Yomtov's Cordis Corporation Experience 1978 - 1988
Job Chief Technical Officer and Cofounder at AdvaStim
Industry Medical Devices
Experience
AdvaStim April 2011 - Present
CIRTEC Medical Systems August 2010 - March 2011
HeartWare 2006 - 2010
Massachusetts Eye and Ear 2005 - 2006
MicroCHIPS 2001 - 2004
Abiomed 1999 - 2001
InControl 1991 - 1998
Cordis Corporation 1978 - 1988
Skills
Medical Devices, Biomedical Engineering, Design Control, R&D, ISO 13485, FDA, Commercialization, Biotechnology, Lifesciences, Cross-functional Team..., Technology Transfer, Product Development, Start-ups, Product Launch, Electronics, Engineering, Quality System, Patents
Education
Rensselaer Polytechnic Institute 1973 — 1978
M. Eng., Biomedical Engineering (Electronics)
AdvaStim April 2011 - Present
CIRTEC Medical Systems August 2010 - March 2011
HeartWare 2006 - 2010
Massachusetts Eye and Ear 2005 - 2006
MicroCHIPS 2001 - 2004
Abiomed 1999 - 2001
InControl 1991 - 1998
Cordis Corporation 1978 - 1988
Skills
Medical Devices, Biomedical Engineering, Design Control, R&D, ISO 13485, FDA, Commercialization, Biotechnology, Lifesciences, Cross-functional Team..., Technology Transfer, Product Development, Start-ups, Product Launch, Electronics, Engineering, Quality System, Patents
Education
Rensselaer Polytechnic Institute 1973 — 1978
M. Eng., Biomedical Engineering (Electronics)
Sheila Weston, MHA Sheila Weston, MHA's Cordis Corporation Experience August 2009 - April 2012
Job Sr Manager, Physician Training Edwards Lifesciences Transcatheter Heart Valves
Industry Medical Devices
Experience
Edwards Lifesciences July 2012 - Present
Cordis Corporation August 2009 - April 2012
CORDIS CORPORATION July 2007 - August 2009
CORDIS CORPORATION September 2002 - July 2007
PARKWEST MEDICAL CENTER December 2000 - September 2002
Methodist Medical Center of Oak Ridge February 1994 - December 2000
Skills
Interventional..., Peripheral Vascular, Medical Devices, Key Opinion Leaders..., P&L Responsibilities, Strategic Planning, Process Improvement, Customer Relations, Radiation Safety, Health Care Compliance, CME Grant Writing, CME Grant Management, Project Management, Cross-functional Team..., Coaching, Medical Content..., Health Care..., Clinical Trials..., Grant Writing, CME, Product Launch, Hospitals, Strategy, Training, Program Management, Clinical Trials, Employee Training, Cath Lab, Vascular, Medical Imaging, Medical Affairs, Cardiovascular Disease, Physicians, Key Opinion Leaders, Management, Budgets, Customer Service, Interventional Radiology, Healthcare, Leadership, Radiology, Healthcare Industry, Clinical Research, Capital Equipment, Urology, Cardiology, Operating Room
Education
Seton Hall University School of Law 2013 — 2013
Healthcare Compliance Certification, Healthcare Compliance
University of St. Francis 1997 — 1999
MASTERS, HEALTH SERVICES ADMINISTRATION
Tennessee Weselyan College 1994 — 1997
BACHELOR OF SCIENCE, HEALTH SERVICES ADMINISTRATION
Roane State Community College 1980 — 1982
Associate of Science, Radiology
Edwards Lifesciences July 2012 - Present
Cordis Corporation August 2009 - April 2012
CORDIS CORPORATION July 2007 - August 2009
CORDIS CORPORATION September 2002 - July 2007
PARKWEST MEDICAL CENTER December 2000 - September 2002
Methodist Medical Center of Oak Ridge February 1994 - December 2000
Skills
Interventional..., Peripheral Vascular, Medical Devices, Key Opinion Leaders..., P&L Responsibilities, Strategic Planning, Process Improvement, Customer Relations, Radiation Safety, Health Care Compliance, CME Grant Writing, CME Grant Management, Project Management, Cross-functional Team..., Coaching, Medical Content..., Health Care..., Clinical Trials..., Grant Writing, CME, Product Launch, Hospitals, Strategy, Training, Program Management, Clinical Trials, Employee Training, Cath Lab, Vascular, Medical Imaging, Medical Affairs, Cardiovascular Disease, Physicians, Key Opinion Leaders, Management, Budgets, Customer Service, Interventional Radiology, Healthcare, Leadership, Radiology, Healthcare Industry, Clinical Research, Capital Equipment, Urology, Cardiology, Operating Room
Education
Seton Hall University School of Law 2013 — 2013
Healthcare Compliance Certification, Healthcare Compliance
University of St. Francis 1997 — 1999
MASTERS, HEALTH SERVICES ADMINISTRATION
Tennessee Weselyan College 1994 — 1997
BACHELOR OF SCIENCE, HEALTH SERVICES ADMINISTRATION
Roane State Community College 1980 — 1982
Associate of Science, Radiology
Jesus J. Martinez Jesus J. Martinez's Cordis Corporation Experience August 1994 - December 1995
Job Manufacturing Supervisor at HeartWare LLC
Industry Medical Devices
Experience
HeartWare LLC February 2014 - Present
Edwards Lifesciences March 2010 - January 2014
Aenova Swiss Caps April 2013 - August 2013
Edwards Lifesciences January 2010 - March 2010
Noven Pharmaceuticals April 2004 - November 2009
Boston Scientific August 2003 - April 2004
JOHNSON and JOHNSON January 2000 - August 2003
JOHNSON and JOHNSON January 1996 - December 1999
CORDIS CORPORATION August 1994 - December 1995
CORDIS CORPORATION January 1993 - August 1994
Skills
Medical Devices..., Validations, Lean Manufacturing, Six Sigma, SPC, Materials Management, Manufacturing, V&V, Medical Devices, ERP, Process Engineering, Procurement, Quality Control, Inventory Management, Continuous Improvement, CAPA, DMAIC, Root Cause Analysis, Kaizen, Change Control, ISO 13485, GMP, ISO, Design Control, Quality Management, Cross-functional Team..., Supply Chain Management, R&D, FDA, Validation, Quality System, Process Improvement, Sop, Manufacturing Operations, Software Documentation, Design of Experiments, Production Planning, Kanban, Quality Assurance, FMEA, Minitab, Engineering, Process Simulation, Value Stream Mapping, 5S, Iso 9000, 21 CFR Part 11, ISO 14971, FDA GMP, Quality Auditing
Education
Nova Southeastern University 2007 — 2009
Master of Business Administration
Nova Southeastern University 2004 — 2006
Bachelor of Science Degree
Miami Dade College 2001 — 2004
Associate in Arts Degree
HeartWare LLC February 2014 - Present
Edwards Lifesciences March 2010 - January 2014
Aenova Swiss Caps April 2013 - August 2013
Edwards Lifesciences January 2010 - March 2010
Noven Pharmaceuticals April 2004 - November 2009
Boston Scientific August 2003 - April 2004
JOHNSON and JOHNSON January 2000 - August 2003
JOHNSON and JOHNSON January 1996 - December 1999
CORDIS CORPORATION August 1994 - December 1995
CORDIS CORPORATION January 1993 - August 1994
Skills
Medical Devices..., Validations, Lean Manufacturing, Six Sigma, SPC, Materials Management, Manufacturing, V&V, Medical Devices, ERP, Process Engineering, Procurement, Quality Control, Inventory Management, Continuous Improvement, CAPA, DMAIC, Root Cause Analysis, Kaizen, Change Control, ISO 13485, GMP, ISO, Design Control, Quality Management, Cross-functional Team..., Supply Chain Management, R&D, FDA, Validation, Quality System, Process Improvement, Sop, Manufacturing Operations, Software Documentation, Design of Experiments, Production Planning, Kanban, Quality Assurance, FMEA, Minitab, Engineering, Process Simulation, Value Stream Mapping, 5S, Iso 9000, 21 CFR Part 11, ISO 14971, FDA GMP, Quality Auditing
Education
Nova Southeastern University 2007 — 2009
Master of Business Administration
Nova Southeastern University 2004 — 2006
Bachelor of Science Degree
Miami Dade College 2001 — 2004
Associate in Arts Degree
John W. (Bill) Atchley John W. (Bill) Atchley's Cordis Corporation Experience January 1996 - January 2007
Job Coronary Account Manager at Volcano Corporation
Industry Medical Devices
Experience
Volcano Corporation April 2014 - Present
Volcano Corporation 2014 - 2015
Volcano Corporation 2014 - 2015
Estech December 2012 - March 2014
Merrill Lynch August 2011 - December 2012
nContact Surgical October 2007 - April 2011
Cordis July 1996 - August 2007
CORDIS CORPORATION January 1996 - January 2007
Cordis January 2000 - July 2006
SPACELABS MEDICAL January 1994 - January 1996
Skills
Series 7 & 66 License, Sales, Business Planning, Marketing, Negotiation, Management, Recruiting, Medical Diagnostics, Consulting, Information Systems, Windows 2000, Capital Equipment, Hospitals, Operating Room, Medical Devices, Cardiology, Surgeons, Selling, Clinical Research, Healthcare, Healthcare Management, Sales Operations, Physicians, Direct Sales, Sales Management, Product Launch, Cardiac Surgery, Start-ups, Business Development, Vascular, Leadership, Surgical Instruments, Product Development, Market Development, Sales Force Development, Urology, Orthopedic, Disposables, Interventional..., Sales Effectiveness, Pharmaceutical Sales
Education
Jacksonville State University 1974 — 1976
BS, Business Administration
Jacksonville State University 1973 — 1976
BS, Business Administration
Duke University - Fuqua School of Business
Executive Education program
Harvard Business School
Excecutive Education Program
Volcano Corporation April 2014 - Present
Volcano Corporation 2014 - 2015
Volcano Corporation 2014 - 2015
Estech December 2012 - March 2014
Merrill Lynch August 2011 - December 2012
nContact Surgical October 2007 - April 2011
Cordis July 1996 - August 2007
CORDIS CORPORATION January 1996 - January 2007
Cordis January 2000 - July 2006
SPACELABS MEDICAL January 1994 - January 1996
Skills
Series 7 & 66 License, Sales, Business Planning, Marketing, Negotiation, Management, Recruiting, Medical Diagnostics, Consulting, Information Systems, Windows 2000, Capital Equipment, Hospitals, Operating Room, Medical Devices, Cardiology, Surgeons, Selling, Clinical Research, Healthcare, Healthcare Management, Sales Operations, Physicians, Direct Sales, Sales Management, Product Launch, Cardiac Surgery, Start-ups, Business Development, Vascular, Leadership, Surgical Instruments, Product Development, Market Development, Sales Force Development, Urology, Orthopedic, Disposables, Interventional..., Sales Effectiveness, Pharmaceutical Sales
Education
Jacksonville State University 1974 — 1976
BS, Business Administration
Jacksonville State University 1973 — 1976
BS, Business Administration
Duke University - Fuqua School of Business
Executive Education program
Harvard Business School
Excecutive Education Program
Herbert Phinn's Cordis Corporation Experience July 1993 - March 2009
Job Manufacturing Engineer (Medical Device) at Atrium Medical, Hudson New Hampshire.
Industry Medical Devices
Experience
Atrium Medical/Maquet Getinge Group January 2014 - Present
Stryker Sustainability Solutions September 2012 - October 2013
Boston Scientific Corporation June 2010 - September 2011
Cordis Corporation July 1993 - March 2009
GUINESS JAMAICA LTD January 1990 - January 1993
Skills
Testing, ISO, Medical Devices, Process Improvement, Catheters, FDA, Validation, R&D, QC, Excel, Troubleshooting, Visio, Word, Minitab, Quality Systems, FMEA, Manufacturing, GMP, Design Control, Lean Manufacturing, Six Sigma, 5S, Assembly
Education
Florida International University 1985 — 1997
BSME, Thermodynamics, Engineering Graphics, Fluid Mechanics
University of Technology 1978 — 1982
Diploma, Mechanical Engineering
Atrium Medical/Maquet Getinge Group January 2014 - Present
Stryker Sustainability Solutions September 2012 - October 2013
Boston Scientific Corporation June 2010 - September 2011
Cordis Corporation July 1993 - March 2009
GUINESS JAMAICA LTD January 1990 - January 1993
Skills
Testing, ISO, Medical Devices, Process Improvement, Catheters, FDA, Validation, R&D, QC, Excel, Troubleshooting, Visio, Word, Minitab, Quality Systems, FMEA, Manufacturing, GMP, Design Control, Lean Manufacturing, Six Sigma, 5S, Assembly
Education
Florida International University 1985 — 1997
BSME, Thermodynamics, Engineering Graphics, Fluid Mechanics
University of Technology 1978 — 1982
Diploma, Mechanical Engineering
Jason Sullivan Jason Sullivan's Cordis Corporation Experience 2001 - August 2014
Job Senior Design Engineer at Ethicon, Inc.
Industry Medical Devices
Experience
Ethicon, Inc. August 2014 - Present
Sullivan Medical Device Consulting LLC October 2011 - Present
Cordis Corporation 2001 - August 2014
Boston Scientific Corporation 1997 - 2000
Datascope Corporation 1996 - 1997
Boston Scientific Corporation 1991 - 1996
Skills
Medical Devices, Design Control, FDA, Commercialization, Product Development, R&D, Validation, Cross-functional Team..., Quality System, Product Launch, Design Verification..., CE marking, International Standards, Stents, Catheters, Project Management, Vena Cava Filters, Business Planning, Project Analysis, Voice of the Customer, Technical Staff...
Education
New York University - Leonard N. Stern School of Business 2000 — 2002
MBA, Finance, Marketing
Massachusetts Institute of Technology 1989 — 1993
Bachelor of Science (BS), Materials Science and Engineering
Additional Course Work:
Ethicon, Inc. August 2014 - Present
Sullivan Medical Device Consulting LLC October 2011 - Present
Cordis Corporation 2001 - August 2014
Boston Scientific Corporation 1997 - 2000
Datascope Corporation 1996 - 1997
Boston Scientific Corporation 1991 - 1996
Skills
Medical Devices, Design Control, FDA, Commercialization, Product Development, R&D, Validation, Cross-functional Team..., Quality System, Product Launch, Design Verification..., CE marking, International Standards, Stents, Catheters, Project Management, Vena Cava Filters, Business Planning, Project Analysis, Voice of the Customer, Technical Staff...
Education
New York University - Leonard N. Stern School of Business 2000 — 2002
MBA, Finance, Marketing
Massachusetts Institute of Technology 1989 — 1993
Bachelor of Science (BS), Materials Science and Engineering
Additional Course Work:
Brett Millard's Cordis Corporation Experience June 2008 - January 2009
Job Investment Banking Associate at Duff & Phelps
Industry Investment Banking
Experience
Duff & Phelps August 2013 - Present
Periculum Capital Company, LLC March 2012 - August 2013
Business Appraisal Services LLC June 2010 - March 2012
Butler Business Accelerator May 2009 - May 2010
Cordis Corporation June 2008 - January 2009
Skills
Financial Analysis, Financial Modeling, Business Valuation, Valuation, Financial Reporting, Excel, Word, Small Business, Investments, Microsoft Word, Microsoft Excel, Due Diligence
Education
Butler University - College of Business Administration 2006 — 2010
BS, Finance
Duff & Phelps August 2013 - Present
Periculum Capital Company, LLC March 2012 - August 2013
Business Appraisal Services LLC June 2010 - March 2012
Butler Business Accelerator May 2009 - May 2010
Cordis Corporation June 2008 - January 2009
Skills
Financial Analysis, Financial Modeling, Business Valuation, Valuation, Financial Reporting, Excel, Word, Small Business, Investments, Microsoft Word, Microsoft Excel, Due Diligence
Education
Butler University - College of Business Administration 2006 — 2010
BS, Finance
Colleen Hittle's Cordis Corporation Experience 1991 - 1995
Job Engineer, FDA Expert, Life Sciences Managing Director
Industry Medical Devices
Experience
Navigant July 2013 - Present
The Anson Group March 2011 - June 2013
The Anson Group 2006 - 2010
The Anson Group 1997 - 2006
HemoCleanse January 1996 - January 1998
Baxter Heyer Schulte January 1995 - January 1996
Cordis Corporation 1991 - 1995
Skills
Compliance, Regulatory Strategy, Quality System..., Medical Devices, FDA, ISO 13485, CAPA, Regulatory Affairs, Pharmaceutical Industry, Biotechnology, Validation, GMP, V&V, Regulatory Submissions, Start-ups, Quality Assurance, Lifesciences, Design Control, Technology Transfer, Sop, ISO, Quality Auditing, Healthcare
Education
Purdue University 1986 — 1991
Bachelor of Science (BS), Industrial Engineering
Purdue University 1986 — 1991
BS, Industrial Engineering
WLHS 1982 — 1986
Navigant July 2013 - Present
The Anson Group March 2011 - June 2013
The Anson Group 2006 - 2010
The Anson Group 1997 - 2006
HemoCleanse January 1996 - January 1998
Baxter Heyer Schulte January 1995 - January 1996
Cordis Corporation 1991 - 1995
Skills
Compliance, Regulatory Strategy, Quality System..., Medical Devices, FDA, ISO 13485, CAPA, Regulatory Affairs, Pharmaceutical Industry, Biotechnology, Validation, GMP, V&V, Regulatory Submissions, Start-ups, Quality Assurance, Lifesciences, Design Control, Technology Transfer, Sop, ISO, Quality Auditing, Healthcare
Education
Purdue University 1986 — 1991
Bachelor of Science (BS), Industrial Engineering
Purdue University 1986 — 1991
BS, Industrial Engineering
WLHS 1982 — 1986
William Weigel William Weigel's Cordis Corporation Experience 1986 - 1988
Job Principal at Beam Reach Consulting LLC
Industry Medical Devices
Experience
Beam Reach Consulting LLC April 2015 - Present
NxStage Medical January 2010 - March 2015
Maine Adaptive Sports & Recreation 2012 - 2015
NxStage Medical November 2002 - December 2009
NxStage Medical October 2001 - October 2002
Celestica 2000 - 2001
Seabrook International 1998 - 2000
Lanco Assembly Systems 1996 - 1998
Bath Iron Works 1989 - 1996
Cordis Corporation 1986 - 1988
Skills
Biomedical Engineering, CAPA, Capital Equipment, Cross-functional Team..., Design Control, Engineering, Engineering Management, FDA, ISO 13485, Manufacturing, Manufacturing..., Medical Devices, Operations Management, Product Development, Product Launch, Product Management, Program Management, Quality System, V, Validation
Education
D'Amore-McKim School of Business at Northeastern University 1994 — 1996
MBA
University of Vermont 1980 — 1984
BSME
Beam Reach Consulting LLC April 2015 - Present
NxStage Medical January 2010 - March 2015
Maine Adaptive Sports & Recreation 2012 - 2015
NxStage Medical November 2002 - December 2009
NxStage Medical October 2001 - October 2002
Celestica 2000 - 2001
Seabrook International 1998 - 2000
Lanco Assembly Systems 1996 - 1998
Bath Iron Works 1989 - 1996
Cordis Corporation 1986 - 1988
Skills
Biomedical Engineering, CAPA, Capital Equipment, Cross-functional Team..., Design Control, Engineering, Engineering Management, FDA, ISO 13485, Manufacturing, Manufacturing..., Medical Devices, Operations Management, Product Development, Product Launch, Product Management, Program Management, Quality System, V, Validation
Education
D'Amore-McKim School of Business at Northeastern University 1994 — 1996
MBA
University of Vermont 1980 — 1984
BSME
Howard Staggs Howard Staggs's Cordis Corporation Experience 1977 - 1980
Job VP of Operations, Multitronics VMI
Industry Automotive
Experience
Multitronics VMI April 2008 - Present
HS Designs, LLC September 2002 - April 2008
Bandwidth9 2000 - 2002
US Assemblies 1999 - 2000
World Access Inc. 1998 - 1998
Healthdyne Technologies 1997 - 1998
Digital Switch Corporation 1990 - 1996
Northern Telecom 1981 - 1990
Cordis Corporation 1977 - 1980
Education
Florida International University 1975 — 1976
BSEET, Electronic Engineering
Multitronics VMI April 2008 - Present
HS Designs, LLC September 2002 - April 2008
Bandwidth9 2000 - 2002
US Assemblies 1999 - 2000
World Access Inc. 1998 - 1998
Healthdyne Technologies 1997 - 1998
Digital Switch Corporation 1990 - 1996
Northern Telecom 1981 - 1990
Cordis Corporation 1977 - 1980
Education
Florida International University 1975 — 1976
BSEET, Electronic Engineering
Maria Darsono Maria Darsono's Cordis Corporation Experience June 2007 - December 2007
Job Graduate Research Assistant at Michigan State University
Industry Research
Experience
Biodegradable Material Research Group, Michigan State University January 2008 - December 2010
Mead Johnson Nutritions January 2009 - June 2009
Cordis Corporation June 2007 - December 2007
Skills
Cross-functional Team..., Materials, Manufacturing
Education
Michigan State University 2008 — 2010
Master of Science, Packaging
Michigan State University 2003 — 2007
B.S., Chemical Engineering
Biodegradable Material Research Group, Michigan State University January 2008 - December 2010
Mead Johnson Nutritions January 2009 - June 2009
Cordis Corporation June 2007 - December 2007
Skills
Cross-functional Team..., Materials, Manufacturing
Education
Michigan State University 2008 — 2010
Master of Science, Packaging
Michigan State University 2003 — 2007
B.S., Chemical Engineering
Wayne Stewart Wayne Stewart's Cordis Corporation Experience April 2000 - June 2003
Job Director, Business Development at Aurora Diagnostics
Industry Medical Practice
Experience
Acadia Healthcare 2014 - Present
Acadia Healthcare 2015 - 2015
Aurora Diagnostics March 2013 - 2015
Clarity Now 2013 - 2015
Lighthouse Network December 2010 - March 2013
Pathology Solutions November 2009 - March 2011
Curran Partners, Inc. 2004 - 2008
Bracco 2004 - 2005
Vasomedical July 2003 - October 2004
Cordis Corporation April 2000 - June 2003
Skills
Operating Room, Market Development, Capital Equipment, Medical Devices, Cardiology, Healthcare, Orthopedic, Program Management, Hospitals, Urology, Product Launch, Leadership, Managed Care, Pharmaceutical Sales, Sales Effectiveness, Management, Dermatology, Business Development, Sales, Treatment, Clinical Research, Neurology, Team Building, Cross-functional Team..., Executive Management, Account Management, Leadership Development, Selling, Oncology, Hardware Diagnostics, Sales Force Development, Sales Operations, Healthcare Industry, OB/GYN, Selling Skills, Gastroenterology
Education
La Salle University
MBA, Management
Acadia Healthcare 2014 - Present
Acadia Healthcare 2015 - 2015
Aurora Diagnostics March 2013 - 2015
Clarity Now 2013 - 2015
Lighthouse Network December 2010 - March 2013
Pathology Solutions November 2009 - March 2011
Curran Partners, Inc. 2004 - 2008
Bracco 2004 - 2005
Vasomedical July 2003 - October 2004
Cordis Corporation April 2000 - June 2003
Skills
Operating Room, Market Development, Capital Equipment, Medical Devices, Cardiology, Healthcare, Orthopedic, Program Management, Hospitals, Urology, Product Launch, Leadership, Managed Care, Pharmaceutical Sales, Sales Effectiveness, Management, Dermatology, Business Development, Sales, Treatment, Clinical Research, Neurology, Team Building, Cross-functional Team..., Executive Management, Account Management, Leadership Development, Selling, Oncology, Hardware Diagnostics, Sales Force Development, Sales Operations, Healthcare Industry, OB/GYN, Selling Skills, Gastroenterology
Education
La Salle University
MBA, Management
Ronald Kuzmirek Ronald Kuzmirek's Cordis Corporation Experience May 1985 - May 1987
Job Chief Financial Officer
Industry Accounting
Experience
IBACOS, Inc. 2010 - Present
Brady Communications June 2002 - January 2010
Interactive Media Corporation June 1993 - March 2002
Cimflex Teknowledge Corporation February 1991 - June 1993
Telectronics Pacing Systems May 1987 - October 1990
Cordis Corporation May 1985 - May 1987
Cordis Corporation September 1984 - April 1985
Cordis Corporation October 1983 - August 1984
Cordis Corporation March 1981 - September 1983
ARCO Medical Products June 1979 - February 1981
Skills
General Ledger, Cost Accounting, Forecasting, Financial Reporting, Budgets
Education
Indiana University of Pennsylvania 1975 — 1979
Bachelor of Science (BS), Accounting
IBACOS, Inc. 2010 - Present
Brady Communications June 2002 - January 2010
Interactive Media Corporation June 1993 - March 2002
Cimflex Teknowledge Corporation February 1991 - June 1993
Telectronics Pacing Systems May 1987 - October 1990
Cordis Corporation May 1985 - May 1987
Cordis Corporation September 1984 - April 1985
Cordis Corporation October 1983 - August 1984
Cordis Corporation March 1981 - September 1983
ARCO Medical Products June 1979 - February 1981
Skills
General Ledger, Cost Accounting, Forecasting, Financial Reporting, Budgets
Education
Indiana University of Pennsylvania 1975 — 1979
Bachelor of Science (BS), Accounting
Andrea Slater Tomko's Cordis Corporation Experience 1990 - 1993
Job Senior Manager, Enrichment R&D at Johnson & Johnson Diabetes Solutions Companies
Industry Medical Devices
Experience
Johnson & Johnson Diabetes Solutions Companies 2011 - Present
Ortho Clinical Diagnostics, Johnson & Johnson 2010 - 2011
Johnson & Johnson Internal Ventures 2006 - 2010
Ethicon, Inc., Johnson & Johnson 2003 - 2006
Ethicon, Inc., Johnson & Johnson 2001 - 2003
Ethicon, Inc., Johnson & Johnson 1998 - 2001
Cordis a Johnson & Johnson Co. 1995 - 1998
Boston Scientific 1993 - 1995
Cordis Corporation 1990 - 1993
CR Bard 1982 - 1990
Skills
Medical Devices, Patents, Technology Evaluation, R&D, Diagnostics, Intellectual Property, Product Development, Start-ups, Due Diligence, Commercialization, Cross-functional Team..., Competitive Intelligence, Strategy Development, Competitive Analysis, Program Management, Business Strategy, Licensing, Market Research, New Business Development, Product Launch, ISO 13485, Intellectual Asset..., Patent Portfolio..., White Space Analysis, Design Control, Product Marketing, Global Marketing, Leadership, Market Development, Biotechnology, Pharmaceutical Industry, Technology Transfer, FDA, Validation, Lifesciences, Regulatory Affairs, Product Innovation, Strategy, Biomedical Engineering, Venture Capital, Quality System, Mergers & Acquisitions, Business Development, GMP, Management, Life Sciences
Education
Rutgers, The State University of New Jersey-New Brunswick
MBA Certification
Union College
BSME, Mechanical Engineering
Union College
BS, Biology
Johnson & Johnson Diabetes Solutions Companies 2011 - Present
Ortho Clinical Diagnostics, Johnson & Johnson 2010 - 2011
Johnson & Johnson Internal Ventures 2006 - 2010
Ethicon, Inc., Johnson & Johnson 2003 - 2006
Ethicon, Inc., Johnson & Johnson 2001 - 2003
Ethicon, Inc., Johnson & Johnson 1998 - 2001
Cordis a Johnson & Johnson Co. 1995 - 1998
Boston Scientific 1993 - 1995
Cordis Corporation 1990 - 1993
CR Bard 1982 - 1990
Skills
Medical Devices, Patents, Technology Evaluation, R&D, Diagnostics, Intellectual Property, Product Development, Start-ups, Due Diligence, Commercialization, Cross-functional Team..., Competitive Intelligence, Strategy Development, Competitive Analysis, Program Management, Business Strategy, Licensing, Market Research, New Business Development, Product Launch, ISO 13485, Intellectual Asset..., Patent Portfolio..., White Space Analysis, Design Control, Product Marketing, Global Marketing, Leadership, Market Development, Biotechnology, Pharmaceutical Industry, Technology Transfer, FDA, Validation, Lifesciences, Regulatory Affairs, Product Innovation, Strategy, Biomedical Engineering, Venture Capital, Quality System, Mergers & Acquisitions, Business Development, GMP, Management, Life Sciences
Education
Rutgers, The State University of New Jersey-New Brunswick
MBA Certification
Union College
BSME, Mechanical Engineering
Union College
BS, Biology
Ted Slack, DD Ted Slack, DD's Cordis Corporation Experience 1977 - 1979
Job Heretic
Industry Machinery
Experience
/dev/null March 1999 - Present
Lockheed Martin Manned Space Systems August 1997 - March 1999
Enviromental Aeroscience June 1993 - June 1997
Symbiosis Corporation September 1991 - May 1996
Hewlett-Packard January 1983 - September 1991
Intermedics 1981 - 1982
Dynatote 1979 - 1981
Cordis Corporation 1977 - 1979
Bliss & Nyitray - Structural Engineers 1974 - 1978
Skills
Testing, Engineering, Electronics, Manufacturing, Medical Devices, Programming, Automation, Design of Experiments, Manufacturing..., Machining, Instrumentation, Root Cause Analysis, Quality Control, Quality Assurance, Product Development
Education
Miami Dade College 1973 — 1975
AA, Electronics
Florida Institute of Technology 1970 — 1971
n/a, Physics
Sunset Elementary
/dev/null March 1999 - Present
Lockheed Martin Manned Space Systems August 1997 - March 1999
Enviromental Aeroscience June 1993 - June 1997
Symbiosis Corporation September 1991 - May 1996
Hewlett-Packard January 1983 - September 1991
Intermedics 1981 - 1982
Dynatote 1979 - 1981
Cordis Corporation 1977 - 1979
Bliss & Nyitray - Structural Engineers 1974 - 1978
Skills
Testing, Engineering, Electronics, Manufacturing, Medical Devices, Programming, Automation, Design of Experiments, Manufacturing..., Machining, Instrumentation, Root Cause Analysis, Quality Control, Quality Assurance, Product Development
Education
Miami Dade College 1973 — 1975
AA, Electronics
Florida Institute of Technology 1970 — 1971
n/a, Physics
Sunset Elementary
Carrie O'Brien Carrie O'Brien's Cordis Corporation Experience January 2001 - December 2007
Job Executive Coach
Industry Professional Training & Coaching
Experience
New Leadership Distinctions LLC July 2012 - Present
Johnson & Johnson November 2009 - June 2011
Johnson & Johnson January 2008 - October 2009
Cordis Corporation January 2001 - December 2007
McNeil Consumer Products Company June 1981 - December 2000
Skills
Change Management, Cross-functional Team..., Vendor Management, IT Strategy, Management Development, Process Improvement, Project Portfolio..., SDLC, IT Management, Project Management, Leadership, Coaching, Business Analysis, Program Management, Strategic Planning, PMP, Business Process, Business Intelligence, Business Process..., Management Consulting, Team Building, Six Sigma, Outsourcing, Strategy, Quality Assurance, Executive Coaching, Team Leadership, Personal Development, Organizational..., Management, Governance, Consulting, Business Strategy, Performance Management, Leadership Development, Executive Management, Start-ups, Organizational Design, ERP, Talent Management, PMO, Business Planning, Integration, Emotional Intelligence, Business Transformation, Organizational..., Culture Change, Workshop Facilitation, Strategic Thinking, People Management
Education
Arcadia University 1983 — 1990
BS, Computer Science
New Leadership Distinctions LLC July 2012 - Present
Johnson & Johnson November 2009 - June 2011
Johnson & Johnson January 2008 - October 2009
Cordis Corporation January 2001 - December 2007
McNeil Consumer Products Company June 1981 - December 2000
Skills
Change Management, Cross-functional Team..., Vendor Management, IT Strategy, Management Development, Process Improvement, Project Portfolio..., SDLC, IT Management, Project Management, Leadership, Coaching, Business Analysis, Program Management, Strategic Planning, PMP, Business Process, Business Intelligence, Business Process..., Management Consulting, Team Building, Six Sigma, Outsourcing, Strategy, Quality Assurance, Executive Coaching, Team Leadership, Personal Development, Organizational..., Management, Governance, Consulting, Business Strategy, Performance Management, Leadership Development, Executive Management, Start-ups, Organizational Design, ERP, Talent Management, PMO, Business Planning, Integration, Emotional Intelligence, Business Transformation, Organizational..., Culture Change, Workshop Facilitation, Strategic Thinking, People Management
Education
Arcadia University 1983 — 1990
BS, Computer Science
Timothy Banc Timothy Banc's Cordis Corporation Experience April 2007 - March 2011
Job Regional Manager at Medtronic (formerly Covidien Peripheral Vascular)
Industry Medical Devices
Experience
Covidien March 2011 - Present
Cordis Corporation April 2007 - March 2011
Terumo Medical Corporation April 2005 - April 2007
Ethicon Endo Surgery, Inc January 2001 - April 2005
Ethicon Endo-Surgery, Inc. January 2000 - January 2001
Ethicon Endo-Surgery, Inc. February 1996 - January 2000
Ortho Biotech, Inc October 1992 - February 1996
Skills
Sales Management, Sales Force..., Medical Devices, Consultative Selling, Cardiology, Product Launches, Hospitals, Interventional Radiology, Healthcare, Product Launch, Market Development, Sales, Hospital Sales, Urology, Surgeons, Sales Effectiveness, Sales Operations, Selling, Marketing
Education
John Carroll University 1989 — 1992
BA, Political Science
Covidien March 2011 - Present
Cordis Corporation April 2007 - March 2011
Terumo Medical Corporation April 2005 - April 2007
Ethicon Endo Surgery, Inc January 2001 - April 2005
Ethicon Endo-Surgery, Inc. January 2000 - January 2001
Ethicon Endo-Surgery, Inc. February 1996 - January 2000
Ortho Biotech, Inc October 1992 - February 1996
Skills
Sales Management, Sales Force..., Medical Devices, Consultative Selling, Cardiology, Product Launches, Hospitals, Interventional Radiology, Healthcare, Product Launch, Market Development, Sales, Hospital Sales, Urology, Surgeons, Sales Effectiveness, Sales Operations, Selling, Marketing
Education
John Carroll University 1989 — 1992
BA, Political Science
Michele Snyder, CCRA, PMP Michele Snyder, CCRA, PMP's Cordis Corporation Experience 1996 - 1998
Job SENIORLEVEL CLINICAL OPERATIONS / AFFAIRS BIOTECHNOLOGY | MEDICAL DEVICE | PHARMACEUTICAL
Industry Medical Devices
Experience
Upsher-Smith Laboratories April 2012 - Present
Svelte Medical Systems, Inc. 2009 - 2011
Sapphire Therapeutics, Inc. 2006 - 2009
Dimensional HealthCare 2005 - 2006
Schering-Plough 2004 - 2005
PharmaNet, Inc 1999 - 2004
Kern McNeill International 1998 - 1999
Cordis Corporation 1996 - 1998
Ohmeda, Inc 1988 - 1996
Skills
Therapeutic areas, Oncology, Dermatology, SAS, Electronic Data Capture, EDC Platforms, Windows Operating System, Microsoft Office Suite, Project Management, Strategic Planning, Coaching, Mentoring, Team Leadership, Team Motivation, Recruiting, Workforce Planning, Policy Development, International Business, Budgeting, Expense Control, Client Relations, Negotiations, Presentations, Event Planning, Able To Multi-task, Benign Prostatic..., Clinical Trials, Clinical Research, ICH-GCP, FDA, CRO, Budgets, EDC, Clinical Development, Policy, Therapeutic Areas, GCP, Client, Customer Service, Biotechnology, Clinical Operations, CTMS, Cross-functional Team..., Medical Devices, 21 CFR Part 11, Regulatory Submissions, Pharmaceutical Industry, Medical Affairs, Protocol, Medical Writing
Education
Fairleigh Dickinson University 1989 — 1995
Bachelor of Science, Business Management
Berkeley School 1984 — 1986
AAS, Administrative Support
New Providence High School 1980 — 1984
Secondary Education
Upsher-Smith Laboratories April 2012 - Present
Svelte Medical Systems, Inc. 2009 - 2011
Sapphire Therapeutics, Inc. 2006 - 2009
Dimensional HealthCare 2005 - 2006
Schering-Plough 2004 - 2005
PharmaNet, Inc 1999 - 2004
Kern McNeill International 1998 - 1999
Cordis Corporation 1996 - 1998
Ohmeda, Inc 1988 - 1996
Skills
Therapeutic areas, Oncology, Dermatology, SAS, Electronic Data Capture, EDC Platforms, Windows Operating System, Microsoft Office Suite, Project Management, Strategic Planning, Coaching, Mentoring, Team Leadership, Team Motivation, Recruiting, Workforce Planning, Policy Development, International Business, Budgeting, Expense Control, Client Relations, Negotiations, Presentations, Event Planning, Able To Multi-task, Benign Prostatic..., Clinical Trials, Clinical Research, ICH-GCP, FDA, CRO, Budgets, EDC, Clinical Development, Policy, Therapeutic Areas, GCP, Client, Customer Service, Biotechnology, Clinical Operations, CTMS, Cross-functional Team..., Medical Devices, 21 CFR Part 11, Regulatory Submissions, Pharmaceutical Industry, Medical Affairs, Protocol, Medical Writing
Education
Fairleigh Dickinson University 1989 — 1995
Bachelor of Science, Business Management
Berkeley School 1984 — 1986
AAS, Administrative Support
New Providence High School 1980 — 1984
Secondary Education
Rosario Borja Swing Rosario Borja Swing's Cordis Corporation Experience January 2002 - February 2011
Job Regulatory Affairs Specialist Oxford International assigned to Covidien
Industry Medical Devices
Experience
Covidien (Oxford International) August 2013 - Present
Marathon Search Partners for Invacare Corporation August 2012 - June 2013
Black Diamond Networks assigned to Stryker Instruments March 2012 - June 2012
Black Diamond Networks Consultant assigned to Stryker Medical, Inc. March 2011 - June 2012
Cordis Corporation January 2002 - February 2011
Cordis Corporation - a Johnson & Johnson Company January 2002 - February 2011
Heidrick & Struggles 2001 - 2002
TELEFONICA B2B, Inc. January 2000 - January 2001
ADAC LABORATORIES, CORP. - INTERCONTINENTAL REGION January 1996 - January 2000
Skills
Regulatory Affairs, Medical Devices, FDA, Management, Quality Assurance, Quality System, Software Documentation, CAPA, Product Development, GMP, Validation, ISO, Manufacturing, ISO 13485, Strategy, Design Control, Training, 21 CFR Part 11, Cross-functional Team..., Sop, Quality Auditing, ISO 14971, R&D, Regulatory Submissions, Change Control, PMA, Regulatory Requirements, Quality Control, Root Cause Analysis, Quality Management, Pharmaceutical Industry, Biotechnology, Six Sigma, Clinical Trials, Design of Experiments, Product Launch, Commercialization, Healthcare, Leadership
Education
Universidade Federal do Rio Grande do Norte
Nursing, Pediatric Nursing / General Nursing Care / Administration
Covidien (Oxford International) August 2013 - Present
Marathon Search Partners for Invacare Corporation August 2012 - June 2013
Black Diamond Networks assigned to Stryker Instruments March 2012 - June 2012
Black Diamond Networks Consultant assigned to Stryker Medical, Inc. March 2011 - June 2012
Cordis Corporation January 2002 - February 2011
Cordis Corporation - a Johnson & Johnson Company January 2002 - February 2011
Heidrick & Struggles 2001 - 2002
TELEFONICA B2B, Inc. January 2000 - January 2001
ADAC LABORATORIES, CORP. - INTERCONTINENTAL REGION January 1996 - January 2000
Skills
Regulatory Affairs, Medical Devices, FDA, Management, Quality Assurance, Quality System, Software Documentation, CAPA, Product Development, GMP, Validation, ISO, Manufacturing, ISO 13485, Strategy, Design Control, Training, 21 CFR Part 11, Cross-functional Team..., Sop, Quality Auditing, ISO 14971, R&D, Regulatory Submissions, Change Control, PMA, Regulatory Requirements, Quality Control, Root Cause Analysis, Quality Management, Pharmaceutical Industry, Biotechnology, Six Sigma, Clinical Trials, Design of Experiments, Product Launch, Commercialization, Healthcare, Leadership
Education
Universidade Federal do Rio Grande do Norte
Nursing, Pediatric Nursing / General Nursing Care / Administration
Sandra Stunson Sandra Stunson's Cordis Corporation Experience 1977 - 1991
Job Administrator
Industry Law Practice
Experience
Law Office of Raymond S. Bogucki June 2014 - July 2015
JBM/Multiband January 2007 - September 2009
Sibcy Cline Realtors 2001 - 2006
TechnoTrim March 1991 - December 1997
Cordis Corporation 1977 - 1991
Cordis 1987 - 1989
Skills
Real Estate, First Time Home Buyers, Sellers, Master Scheduling, Quality Assurance, Mentoring, Management, TQM, Production Planning, Medical Devices, Coaching
Education
Hondros College 2000 — 2001
Real Estate Agent, Real Estate
Florida International University
Human Resources Management/ Training and Development
Law Office of Raymond S. Bogucki June 2014 - July 2015
JBM/Multiband January 2007 - September 2009
Sibcy Cline Realtors 2001 - 2006
TechnoTrim March 1991 - December 1997
Cordis Corporation 1977 - 1991
Cordis 1987 - 1989
Skills
Real Estate, First Time Home Buyers, Sellers, Master Scheduling, Quality Assurance, Mentoring, Management, TQM, Production Planning, Medical Devices, Coaching
Education
Hondros College 2000 — 2001
Real Estate Agent, Real Estate
Florida International University
Human Resources Management/ Training and Development
Edward Musto Edward Musto's Cordis Corporation Experience May 2005 - March 2007
Job Lead Validation Engineer
Industry Medical Devices
Experience
Medtronic February 2013 - Present
MAKO Surgical Corp. May 2007 - January 2013
Cordis Corporation May 2005 - March 2007
Randstad January 2005 - April 2005
HireNetworks February 2004 - December 2004
Ortho Clinical Diagnostics September 1999 - January 2004
Pall Corporation (Process Equipment Development) September 1990 - March 1999
Skills
Design Control, ISO 13485, Risk Management, ISO 14971, Quality System, MDRs, FMECA, Root Cause Analysis, CAPA, DMAIC, V&V, Test Method Validation, Complaint Management, GD&T, Product Development, Statistical Tools, Medical Devices, Quality Assurance, Test Methodologies, Validation, Six Sigma, ISO, Lean Manufacturing, Quality Control, R&D, FMEA, Cross-functional Team..., Testing, Manufacturing, Design of Experiments, Engineering, SPC, Process Simulation, FDA, Value Stream Mapping, Minitab, Design for Manufacturing
Education
Columbia University - Fu Foundation School of Engineering and Applied Science
BSME, Mechanical Engineering
Medtronic February 2013 - Present
MAKO Surgical Corp. May 2007 - January 2013
Cordis Corporation May 2005 - March 2007
Randstad January 2005 - April 2005
HireNetworks February 2004 - December 2004
Ortho Clinical Diagnostics September 1999 - January 2004
Pall Corporation (Process Equipment Development) September 1990 - March 1999
Skills
Design Control, ISO 13485, Risk Management, ISO 14971, Quality System, MDRs, FMECA, Root Cause Analysis, CAPA, DMAIC, V&V, Test Method Validation, Complaint Management, GD&T, Product Development, Statistical Tools, Medical Devices, Quality Assurance, Test Methodologies, Validation, Six Sigma, ISO, Lean Manufacturing, Quality Control, R&D, FMEA, Cross-functional Team..., Testing, Manufacturing, Design of Experiments, Engineering, SPC, Process Simulation, FDA, Value Stream Mapping, Minitab, Design for Manufacturing
Education
Columbia University - Fu Foundation School of Engineering and Applied Science
BSME, Mechanical Engineering
Tim Helfrich Tim Helfrich's Cordis Corporation Experience September 2013 - April 2015
Job BDM at Medinol USA
Industry Medical Devices
Experience
Medinol USA April 2015 - Present
Cordis Corporation September 2013 - April 2015
AngioScore January 2012 - July 2013
Terumo October 2007 - January 2012
Bard Interventional October 2003 - October 2007
Skills
Cardiology, Surgery, Interventional..., Capital Equipment, Medical Devices, Disposables, Surgeons
Education
Maryville University of Saint Louis 1988 — 1991
Bachelor's degree, Business Administration and Management, General
Medinol USA April 2015 - Present
Cordis Corporation September 2013 - April 2015
AngioScore January 2012 - July 2013
Terumo October 2007 - January 2012
Bard Interventional October 2003 - October 2007
Skills
Cardiology, Surgery, Interventional..., Capital Equipment, Medical Devices, Disposables, Surgeons
Education
Maryville University of Saint Louis 1988 — 1991
Bachelor's degree, Business Administration and Management, General
Christina McGuire Christina McGuire's Cordis Corporation Experience February 2005 - March 2011
Job Principal Post Market Surveillance Specialist
Industry Medical Devices
Experience
Fresenius Medical Care November 2014 - Present
Validant August 2014 - November 2014
DOHMEN March 2014 - June 2014
Maetrics, LLC January 2013 - October 2013
HeartWare Inc March 2011 - March 2012
Cordis Corporation February 2005 - March 2011
Baxter Healthcare Corporation January 1999 - January 2001
Skills
Medical Devices, Validation, ISO 13485, FDA, Quality System, Quality Assurance, CAPA, Quality Management, 21 CFR, GMP, ISO 14971, V, Complaint Management, Software Documentation, Sop, V&V, Regulatory Affairs
Education
Florida International University 2006 — 2008
Bachelors, International Business and Management
Fresenius Medical Care November 2014 - Present
Validant August 2014 - November 2014
DOHMEN March 2014 - June 2014
Maetrics, LLC January 2013 - October 2013
HeartWare Inc March 2011 - March 2012
Cordis Corporation February 2005 - March 2011
Baxter Healthcare Corporation January 1999 - January 2001
Skills
Medical Devices, Validation, ISO 13485, FDA, Quality System, Quality Assurance, CAPA, Quality Management, 21 CFR, GMP, ISO 14971, V, Complaint Management, Software Documentation, Sop, V&V, Regulatory Affairs
Education
Florida International University 2006 — 2008
Bachelors, International Business and Management
Eric M. Kubilus Eric M. Kubilus's Cordis Corporation Experience June 2002 - August 2006
Job Senior Counsel at Franklin Square Capital Partners
Industry Law Practice
Experience
Franklin Square Capital Partners May 2013 - Present
Skadden, Arps, Slate, Meagher & Flom LLP 2009 - 2013
Skadden, Arps, Slate, Meagher & Flom LLP May 2008 - August 2008
Drinker Biddle & Reath LLP May 2007 - August 2007
Cordis Corporation June 2002 - August 2006
Skills
Intellectual Property, Legal Writing, Securities, Contract Negotiation, Legal Advice, Corporate Finance, Securities Regulation, Acquisitions, Arbitration, Capital Markets, Cross-border..., Legal Assistance, Project Finance, Corporate Governance, Corporate Law, Legal Research, Due Diligence
Education
Villanova University School of Law 2006 — 2009
Juris Doctor, Magna Cum Laude
Lehigh University 2002 — 2006
Bachelor of Science (BS), Environmental Engineering
Franklin Square Capital Partners May 2013 - Present
Skadden, Arps, Slate, Meagher & Flom LLP 2009 - 2013
Skadden, Arps, Slate, Meagher & Flom LLP May 2008 - August 2008
Drinker Biddle & Reath LLP May 2007 - August 2007
Cordis Corporation June 2002 - August 2006
Skills
Intellectual Property, Legal Writing, Securities, Contract Negotiation, Legal Advice, Corporate Finance, Securities Regulation, Acquisitions, Arbitration, Capital Markets, Cross-border..., Legal Assistance, Project Finance, Corporate Governance, Corporate Law, Legal Research, Due Diligence
Education
Villanova University School of Law 2006 — 2009
Juris Doctor, Magna Cum Laude
Lehigh University 2002 — 2006
Bachelor of Science (BS), Environmental Engineering
Vernon Dahl Vernon Dahl's Cordis Corporation Experience 1974 - 1984
Job CEO at MitraGen
Industry Medical Devices
Experience
MitraGen, Inc. 2012 - Present
QuantumCor, Inc. 2007 - 2012
CardioMetrix, Inc. 2003 - 2006
Cobra Consulting 1998 - 2003
HMC, Inc. dba: Nursefinders of Puget Sound 1995 - 1997
Guidant Corporation (CRM) 1986 - 1995
Cordis Corporation 1974 - 1984
Skills
Medical Devices, Start-ups, Interventional..., Mergers & Acquisitions, New Business Development, Healthcare, Strategic Planning, Market Analysis, Business Planning, FDA, R&D, Management, Technology Transfer, Cross-functional Team..., Venture Capital, Biotechnology, Business Strategy, Lifesciences, Competitive Analysis
Education
California State University-Northridge
BS, Business Administration / Marketing
MitraGen, Inc. 2012 - Present
QuantumCor, Inc. 2007 - 2012
CardioMetrix, Inc. 2003 - 2006
Cobra Consulting 1998 - 2003
HMC, Inc. dba: Nursefinders of Puget Sound 1995 - 1997
Guidant Corporation (CRM) 1986 - 1995
Cordis Corporation 1974 - 1984
Skills
Medical Devices, Start-ups, Interventional..., Mergers & Acquisitions, New Business Development, Healthcare, Strategic Planning, Market Analysis, Business Planning, FDA, R&D, Management, Technology Transfer, Cross-functional Team..., Venture Capital, Biotechnology, Business Strategy, Lifesciences, Competitive Analysis
Education
California State University-Northridge
BS, Business Administration / Marketing
Raul Leyte-Vidal's Cordis Corporation Experience May 2004 - November 2007
Job Director R&D at Vascular Pathways
Industry Medical Devices
Experience
Vascular Pathways September 2012 - Present
CR Bard September 2009 - August 2012
Disc Motion Technologies, Inc. November 2007 - December 2008
Cordis Corporation May 2004 - November 2007
Niles Audio Corporation September 1997 - August 2001
Skills
Medical Devices, Product Design, Product Development, Catheters, Management, Research, Design Control, FDA, Engineering, Manufacturing, Biomedical Engineering, ISO 13485, Pro Engineer, Solidworks, ISO, Testing, ISO 14971, Design of Experiments, R&D, CAPA, V&V, Quality System, Validation, Biomaterials, Minitab, FMEA, Commercialization, Design for Manufacturing, Injection Molding, DMAIC, Manufacturing..., SPC, Product Launch, Root Cause Analysis, Medical Device R&D, 21 CFR, GMP, Process Simulation, Surgical Instruments, Six Sigma, CQE, Cross-functional Team..., Failure Analysis
Education
University of Miami 2000 — 2004
BS, Biomedical Engineering
Florida International University 2005 — 2007
MS, Engineering Management
Vascular Pathways September 2012 - Present
CR Bard September 2009 - August 2012
Disc Motion Technologies, Inc. November 2007 - December 2008
Cordis Corporation May 2004 - November 2007
Niles Audio Corporation September 1997 - August 2001
Skills
Medical Devices, Product Design, Product Development, Catheters, Management, Research, Design Control, FDA, Engineering, Manufacturing, Biomedical Engineering, ISO 13485, Pro Engineer, Solidworks, ISO, Testing, ISO 14971, Design of Experiments, R&D, CAPA, V&V, Quality System, Validation, Biomaterials, Minitab, FMEA, Commercialization, Design for Manufacturing, Injection Molding, DMAIC, Manufacturing..., SPC, Product Launch, Root Cause Analysis, Medical Device R&D, 21 CFR, GMP, Process Simulation, Surgical Instruments, Six Sigma, CQE, Cross-functional Team..., Failure Analysis
Education
University of Miami 2000 — 2004
BS, Biomedical Engineering
Florida International University 2005 — 2007
MS, Engineering Management
Barbara Derr Barbara Derr's Cordis Corporation Experience 2003 - Present
Job Materials Management, Cordis, a Johnson and Johnson Company
Industry Medical Devices
Experience
Cordis Corporation 2003 - Present
Johnson & Johnson 2000 - 2003
Baxter Healthcare 1985 - 1995
Baxter 1977 - 1985
Education
Northern Illinois University 1985 — 1987
MBA, Finance and Accounting
Michigan State University 1973 — 1977
Cordis Corporation 2003 - Present
Johnson & Johnson 2000 - 2003
Baxter Healthcare 1985 - 1995
Baxter 1977 - 1985
Education
Northern Illinois University 1985 — 1987
MBA, Finance and Accounting
Michigan State University 1973 — 1977
Elisa Ramirez Elisa Ramirez's Cordis Corporation Experience 1998 - 2006
Job Human Resources Manager at Philips
Industry Electrical/Electronic Manufacturing
Experience
Philips October 2006 - Present
Cordis de Mexico a Johnson & Johnson Company 1999 - 2006
Cordis Corporation 1998 - 2006
Skills
Change Management, ISO, Operational Excellence, Onboarding, Process Improvement, Workforce Planning, Talent Management, DMAIC, HRIS, Succession Planning, Validation, Medical Devices, Manufacturing, Deferred Compensation, Coaching, Performance Management, Employee Relations, Leadership Development, Quality System, FDA, Strategic Planning, Lean Manufacturing, Organizational..., Continuous Improvement, Kaizen, HR Policies, Personnel Management, Project Planning, Management, Six Sigma, Team Building, Benefits Administration, Negotiation, Executive Coaching, Green Belt, GMP, Root Cause Analysis, Team Leadership, HR Transformation, Project Management, Minitab, Microsoft Office, Employee Engagement, Quality Management, SAP, Technical Recruiting, Labor Relations, Employment Law, Recruiting, Customer Service
Education
Instituto Tecnológico de Ciudad Juárez 1991 — 1996
Business Administration
Philips October 2006 - Present
Cordis de Mexico a Johnson & Johnson Company 1999 - 2006
Cordis Corporation 1998 - 2006
Skills
Change Management, ISO, Operational Excellence, Onboarding, Process Improvement, Workforce Planning, Talent Management, DMAIC, HRIS, Succession Planning, Validation, Medical Devices, Manufacturing, Deferred Compensation, Coaching, Performance Management, Employee Relations, Leadership Development, Quality System, FDA, Strategic Planning, Lean Manufacturing, Organizational..., Continuous Improvement, Kaizen, HR Policies, Personnel Management, Project Planning, Management, Six Sigma, Team Building, Benefits Administration, Negotiation, Executive Coaching, Green Belt, GMP, Root Cause Analysis, Team Leadership, HR Transformation, Project Management, Minitab, Microsoft Office, Employee Engagement, Quality Management, SAP, Technical Recruiting, Labor Relations, Employment Law, Recruiting, Customer Service
Education
Instituto Tecnológico de Ciudad Juárez 1991 — 1996
Business Administration
Edward Arguello Edward Arguello's Cordis Corporation Experience October 2002 - July 2005
Job Senior Mechanical Engineer at Nipro Healthcare Systems
Industry Medical Devices
Experience
TNI Manufacturing June 2015 - Present
Nipro Healthcare Systems May 2011 - June 2015
Micrus Endovascular June 2007 - May 2011
Neural Engineering Center of Case Western August 2005 - June 2007
Cordis Corporation October 2002 - July 2005
Skills
Design Control, Medical Devices, ISO 13485, V&V, FDA, Design of Experiments, CAPA, Minitab, Catheters, Validation, Quality System, Biomaterials, Solidworks, Product Development, ISO 14971, FMEA, Labview, Engineering, Manufacturing, GMP, Cross-functional Team..., ISO, Injection Molding, R, Six Sigma, Design for Manufacturing, Root Cause Analysis, DMAIC, Project Management, Lean Manufacturing
Education
Case Western Reserve University 2005 — 2007
MS, Biomedical Engineering
University of Miami 1999 — 2003
BS, Biomedical Engineering
North Miami Senior High 1995 — 1999
International Baccalaureate Degree
TNI Manufacturing June 2015 - Present
Nipro Healthcare Systems May 2011 - June 2015
Micrus Endovascular June 2007 - May 2011
Neural Engineering Center of Case Western August 2005 - June 2007
Cordis Corporation October 2002 - July 2005
Skills
Design Control, Medical Devices, ISO 13485, V&V, FDA, Design of Experiments, CAPA, Minitab, Catheters, Validation, Quality System, Biomaterials, Solidworks, Product Development, ISO 14971, FMEA, Labview, Engineering, Manufacturing, GMP, Cross-functional Team..., ISO, Injection Molding, R, Six Sigma, Design for Manufacturing, Root Cause Analysis, DMAIC, Project Management, Lean Manufacturing
Education
Case Western Reserve University 2005 — 2007
MS, Biomedical Engineering
University of Miami 1999 — 2003
BS, Biomedical Engineering
North Miami Senior High 1995 — 1999
International Baccalaureate Degree
Roger Guidi Roger Guidi's Cordis Corporation Experience 1999 - 2000
Job President and CoFounder, Healthcare Associates, LLC
Industry Medical Devices
Experience
Ascension Ventures 2011 - Present
Healthcare Associates, LLC January 2010 - Present
Hourglass Technology, Inc. 2010 - 2012
Johnson & Johnson Development Corp. 2000 - 2009
Cordis Corporation 1999 - 2000
Guidi & Associates 1997 - 1999
Intella Interventional Systems, Inc. 1994 - 1997
VISX 1988 - 1993
Skills
Marketing, Recruiting, Start-ups, Venture Capital, Strategic Planning, Biotechnology, Fundraising, Medical Devices, Commercialization, Private Equity, Entrepreneurship, Management, Product Management, Lifesciences, Strategy, FDA, Corporate Development, Investments, Business Strategy, Due Diligence, Market Development, Product Launch, R&D, Healthcare, Business Development, Executive Management, Regulatory Affairs, Mergers & Acquisitions, Pharmaceutical Industry, Oncology, New Business Development, Biomedical Engineering, Hardware Diagnostics, Design Control, Clinical Trials, Clinical Development, Technology Transfer, ISO 13485, Global Marketing, Cross-functional Team..., Cardiology, Life Sciences
Education
San Jose State University
BA, Biological Sciences
Ascension Ventures 2011 - Present
Healthcare Associates, LLC January 2010 - Present
Hourglass Technology, Inc. 2010 - 2012
Johnson & Johnson Development Corp. 2000 - 2009
Cordis Corporation 1999 - 2000
Guidi & Associates 1997 - 1999
Intella Interventional Systems, Inc. 1994 - 1997
VISX 1988 - 1993
Skills
Marketing, Recruiting, Start-ups, Venture Capital, Strategic Planning, Biotechnology, Fundraising, Medical Devices, Commercialization, Private Equity, Entrepreneurship, Management, Product Management, Lifesciences, Strategy, FDA, Corporate Development, Investments, Business Strategy, Due Diligence, Market Development, Product Launch, R&D, Healthcare, Business Development, Executive Management, Regulatory Affairs, Mergers & Acquisitions, Pharmaceutical Industry, Oncology, New Business Development, Biomedical Engineering, Hardware Diagnostics, Design Control, Clinical Trials, Clinical Development, Technology Transfer, ISO 13485, Global Marketing, Cross-functional Team..., Cardiology, Life Sciences
Education
San Jose State University
BA, Biological Sciences
Luis Brulles Luis Brulles's Cordis Corporation Experience March 1985 - February 1988
Job Service and Applications Engineer
Industry Mechanical or Industrial Engineering
Experience
GF AgieCharmilles April 2011 - Present
Brulles- EDM Applications and Service September 2009 - May 2011
Agie Charmilles Gmbh November 2005 - April 2010
System 3R January 2003 - September 2005
Tec, Inc July 2002 - August 2003
AGIE Ltd April 1994 - July 2002
Precision Products January 1991 - April 1994
Eastern Airlines April 1989 - January 1991
Cordis Corporation March 1985 - February 1988
Skills
Automation, Machine Tools, Engineering, Manufacturing, ISO, Automotive, Process Engineering, Troubleshooting, Cnc, Wire EDM, Testing, Electronics, Machining, Process Improvement
Education
Florida International University 1981 — 1986
BS, Industrial Engineering Technology
Florida International Un
Master's level coursework; BS, Business and Education; Industrial Engineering Technology
Miami Dade College
AA & AS, Mechanical & Electrical Technology
GF AgieCharmilles April 2011 - Present
Brulles- EDM Applications and Service September 2009 - May 2011
Agie Charmilles Gmbh November 2005 - April 2010
System 3R January 2003 - September 2005
Tec, Inc July 2002 - August 2003
AGIE Ltd April 1994 - July 2002
Precision Products January 1991 - April 1994
Eastern Airlines April 1989 - January 1991
Cordis Corporation March 1985 - February 1988
Skills
Automation, Machine Tools, Engineering, Manufacturing, ISO, Automotive, Process Engineering, Troubleshooting, Cnc, Wire EDM, Testing, Electronics, Machining, Process Improvement
Education
Florida International University 1981 — 1986
BS, Industrial Engineering Technology
Florida International Un
Master's level coursework; BS, Business and Education; Industrial Engineering Technology
Miami Dade College
AA & AS, Mechanical & Electrical Technology
Ana (Annie) Vargas Ana (Annie) Vargas's Cordis Corporation Experience 2006 - Present
Job Supply Chain Planning Manager Latin America at Johnson & Johnson
Industry Medical Devices
Experience
Johnson & Johnson May 2012 - Present
Cordis (A Johnson & Johnson Co.) 2006 - Present
Cordis Corporation 2006 - Present
Cordis Corporation a Johnson & Johnson Company September 2006 - May 2012
Cordis Corporation a Johnson & Johnson Company April 2003 - September 2006
Cordis Corporation a Johnson & Johnson Company October 2001 - April 2003
Johnson & Johnson June 2000 - October 2001
Education
Florida International University 2006 — 2007
MSEM, Masters in Engineering Management
Florida International University 1995 — 2001
BS, Bachelor Industrial and Systems Enginnering
Johnson & Johnson May 2012 - Present
Cordis (A Johnson & Johnson Co.) 2006 - Present
Cordis Corporation 2006 - Present
Cordis Corporation a Johnson & Johnson Company September 2006 - May 2012
Cordis Corporation a Johnson & Johnson Company April 2003 - September 2006
Cordis Corporation a Johnson & Johnson Company October 2001 - April 2003
Johnson & Johnson June 2000 - October 2001
Education
Florida International University 2006 — 2007
MSEM, Masters in Engineering Management
Florida International University 1995 — 2001
BS, Bachelor Industrial and Systems Enginnering
Lisset Miranda's Cordis Corporation Experience December 2000 - February 2002
Job Quality Assurance Engineer at Beckman Coulter
Industry Biotechnology
Experience
Beckman Coulter January 2013 - Present
Adecco Technical, Beckman Coulter July 2011 - January 2013
Noven Pharmaceuticals, Inc June 2008 - January 2011
Noven Pharmaceuticals, Inc February 2002 - June 2008
Cordis Corporation December 2000 - February 2002
Cordis Corporation April 1998 - November 2000
Cordis Corporation December 1994 - April 1998
Telectronics Pacing Systems August 1988 - December 1994
Skills
Quality System, Validation, Medical Devices, CAPA, Management, Manufacturing, Quality Assurance, GMP, Project Planning, FDA, Pharmaceutical Industry, Cross-functional Team..., Sop, Software Documentation, V&V, Design Control, R&D, Design of Experiments, Product Launch, Six Sigma, Quality Control, Lean Manufacturing, 21 CFR Part 11, Continuous Improvement, Engineering, Root Cause Analysis, Auditing, ISO 13485
Education
Miami Dade College
AA, Business Management
Beckman Coulter January 2013 - Present
Adecco Technical, Beckman Coulter July 2011 - January 2013
Noven Pharmaceuticals, Inc June 2008 - January 2011
Noven Pharmaceuticals, Inc February 2002 - June 2008
Cordis Corporation December 2000 - February 2002
Cordis Corporation April 1998 - November 2000
Cordis Corporation December 1994 - April 1998
Telectronics Pacing Systems August 1988 - December 1994
Skills
Quality System, Validation, Medical Devices, CAPA, Management, Manufacturing, Quality Assurance, GMP, Project Planning, FDA, Pharmaceutical Industry, Cross-functional Team..., Sop, Software Documentation, V&V, Design Control, R&D, Design of Experiments, Product Launch, Six Sigma, Quality Control, Lean Manufacturing, 21 CFR Part 11, Continuous Improvement, Engineering, Root Cause Analysis, Auditing, ISO 13485
Education
Miami Dade College
AA, Business Management
Justin Ballotta Justin Ballotta's Cordis Corporation Experience December 2006 - November 2007
Job Chief Operating Officer at Cardiva Medical
Industry Medical Devices
Experience
Cardiva Medical July 2015 - Present
Cardiva Medical June 2010 - Present
Johnson & Johnson October 2009 - July 2010
Johnson & Johnson November 2007 - February 2010
Cordis Corporation December 2006 - November 2007
Cordis Europa N.V. - (Netherlands) 2004 - 2006
Cordis Corporation 2003 - 2004
Cordis Corporation 1998 - 2003
Skills
Product Development, Medical Devices, Cross-functional Team..., Product Management, Project Management, Six Sigma, Commercialization, Program Management, Product Launch, Process Improvement, ISO 13485, Design Control, FDA, Manufacturing, Team Building, Quality System, Product Marketing, Process Engineering, Capital Equipment, Market Development, Validation, Leadership, Quality Management, Start-ups, Quality Assurance, Lean Manufacturing, R&D, Minitab, DMAIC, FMEA, GMP, CAPA, Design of Experiments, V&V, Continuous Improvement, Global Marketing, Biomedical Engineering
Education
Columbia Business School
MBA, Business Administration
University of California, Berkeley - Walter A. Haas School of Business
MBA, Business Administration and Management
Florida International University - College of Engineering
Masters, Engineering Management
University of Miami
Bachelor of Science, Biomedical / Mechanical Engineering
Cardiva Medical July 2015 - Present
Cardiva Medical June 2010 - Present
Johnson & Johnson October 2009 - July 2010
Johnson & Johnson November 2007 - February 2010
Cordis Corporation December 2006 - November 2007
Cordis Europa N.V. - (Netherlands) 2004 - 2006
Cordis Corporation 2003 - 2004
Cordis Corporation 1998 - 2003
Skills
Product Development, Medical Devices, Cross-functional Team..., Product Management, Project Management, Six Sigma, Commercialization, Program Management, Product Launch, Process Improvement, ISO 13485, Design Control, FDA, Manufacturing, Team Building, Quality System, Product Marketing, Process Engineering, Capital Equipment, Market Development, Validation, Leadership, Quality Management, Start-ups, Quality Assurance, Lean Manufacturing, R&D, Minitab, DMAIC, FMEA, GMP, CAPA, Design of Experiments, V&V, Continuous Improvement, Global Marketing, Biomedical Engineering
Education
Columbia Business School
MBA, Business Administration
University of California, Berkeley - Walter A. Haas School of Business
MBA, Business Administration and Management
Florida International University - College of Engineering
Masters, Engineering Management
University of Miami
Bachelor of Science, Biomedical / Mechanical Engineering
Greg Foudray's Cordis Corporation Experience 1978 - 1979
Job Adjunct Professor and Farm Land Investor
Industry Information Technology and Services
Experience
Independent Farm Land Investment and Business Development May 2005 - Present
Salem State University September 2007 - Present
Self July 2001 - July 2014
Extraprise Group, Inc 1997 - 2001
Stream Global Services(Formerly Corporate Software) June 1995 - August 1996
Progress Software(former Object Design, Inc. acquisition) 1990 - 1995
Oracle Corporation 1984 - 1990
Racal Milgo 1979 - 1984
Cordis Corporation 1978 - 1979
Unisys (Formerly Burroughs Corporation - Detroit, MI) 1976 - 1978
Skills
Management Consulting, Professional Services, Start-ups, Teaching, Strategic Planning, Higher Education, Strategy, Leadership, Program Management, Building Leadership..., Recruiting, Training, Entrepreneurship, Management, Operations Management, Change Management, Sales, CRM, E-Learning, Leadership Development, Team Leadership, Business Intelligence, Organizational...
Education
Florida International University 1979 — 1982
MBA
Indiana University Bloomington 1972 — 1975
MS
Purdue University 1968 — 1972
BS
Independent Farm Land Investment and Business Development May 2005 - Present
Salem State University September 2007 - Present
Self July 2001 - July 2014
Extraprise Group, Inc 1997 - 2001
Stream Global Services(Formerly Corporate Software) June 1995 - August 1996
Progress Software(former Object Design, Inc. acquisition) 1990 - 1995
Oracle Corporation 1984 - 1990
Racal Milgo 1979 - 1984
Cordis Corporation 1978 - 1979
Unisys (Formerly Burroughs Corporation - Detroit, MI) 1976 - 1978
Skills
Management Consulting, Professional Services, Start-ups, Teaching, Strategic Planning, Higher Education, Strategy, Leadership, Program Management, Building Leadership..., Recruiting, Training, Entrepreneurship, Management, Operations Management, Change Management, Sales, CRM, E-Learning, Leadership Development, Team Leadership, Business Intelligence, Organizational...
Education
Florida International University 1979 — 1982
MBA
Indiana University Bloomington 1972 — 1975
MS
Purdue University 1968 — 1972
BS
Joseph Chi, MBA, ASQ CQA [LION]'s Cordis Corporation Experience June 2004 - June 2005
Job Sr. Quality Consultant at BioTeknica
Industry Management Consulting
Experience
Optos April 2012 - September 2013
Sandoz January 2012 - February 2012
Care Fusion June 2011 - December 2011
Philips Healthcare June 2010 - March 2011
Sandoz January 2010 - June 2010
Laboratorios NeoQuimica February 2009 - December 2009
Zimmer October 2008 - February 2009
Ethicon, Inc. June 2007 - May 2008
Boston Scientific June 2006 - June 2007
Cordis Corporation June 2004 - June 2005
Skills
Six Sigma, Team Leadership, Policy Writing, International Operations, Process Management, Computer System..., Business Development, SDLC, Quality Assurance, Quality System, CAPA, Change Control, GMP, FDA, Pharmaceutical Industry, Program Management, Process Engineering, Cross-functional Team..., Validation, Continuous Improvement, Manufacturing, Strategy, Technology Transfer, Quality Auditing, ISO 13485, Training, Medical Devices, Operational Excellence, Management Consulting, Business Process..., Process Improvement, Management, Root Cause Analysis, 21 CFR Part 11, Testing, Quality Control, Regulatory Affairs, Sop, Biotechnology, Quality Management
Education
University of Miami - School of Business 2004 — 2006
MBA, International Business
Florida International University
BA
Optos April 2012 - September 2013
Sandoz January 2012 - February 2012
Care Fusion June 2011 - December 2011
Philips Healthcare June 2010 - March 2011
Sandoz January 2010 - June 2010
Laboratorios NeoQuimica February 2009 - December 2009
Zimmer October 2008 - February 2009
Ethicon, Inc. June 2007 - May 2008
Boston Scientific June 2006 - June 2007
Cordis Corporation June 2004 - June 2005
Skills
Six Sigma, Team Leadership, Policy Writing, International Operations, Process Management, Computer System..., Business Development, SDLC, Quality Assurance, Quality System, CAPA, Change Control, GMP, FDA, Pharmaceutical Industry, Program Management, Process Engineering, Cross-functional Team..., Validation, Continuous Improvement, Manufacturing, Strategy, Technology Transfer, Quality Auditing, ISO 13485, Training, Medical Devices, Operational Excellence, Management Consulting, Business Process..., Process Improvement, Management, Root Cause Analysis, 21 CFR Part 11, Testing, Quality Control, Regulatory Affairs, Sop, Biotechnology, Quality Management
Education
University of Miami - School of Business 2004 — 2006
MBA, International Business
Florida International University
BA
Yolanda Custodio C.P.M.; CPSM; CPSD's Cordis Corporation Experience February 2005 - January 2010
Job
Industry Pharmaceuticals
Experience
Cross Country Home Services July 2012 - December 2013
International Technidyne Corporation April 2010 - June 2012
Cordis Corporation February 2005 - January 2010
Motorola 2000 - 2001
Digital Equipment Corporation 1977 - 1997
Skills
Supply Chain, Continuous Improvement, Inventory Control, Lean Manufacturing, Six Sigma, Manufacturing, ISO 13485, Inventory Management, MRP, Supply Management, Strategic Sourcing, Medical Devices, Process Improvement, SAP, FDA, Materials Management, Product Development, Logistics, Supplier Evaluation, Purchasing, Cross-functional Team..., Global Sourcing, Procurement, Kaizen, ISO, Quality Management, Production Planning, 5S, Supplier Quality, Quality System, Kanban, Supply Chain Management, Root Cause Analysis
Education
Lesley University 1987 — 1989
Master of Business Administration (M.B.A.)
University of Puerto Rico-Mayaguez 1974 — 1977
Bachelor, Business Adm. Finance
University of Puerto Rico Ponce 1972 — 1974
Associate, Computer Programming
Cross Country Home Services July 2012 - December 2013
International Technidyne Corporation April 2010 - June 2012
Cordis Corporation February 2005 - January 2010
Motorola 2000 - 2001
Digital Equipment Corporation 1977 - 1997
Skills
Supply Chain, Continuous Improvement, Inventory Control, Lean Manufacturing, Six Sigma, Manufacturing, ISO 13485, Inventory Management, MRP, Supply Management, Strategic Sourcing, Medical Devices, Process Improvement, SAP, FDA, Materials Management, Product Development, Logistics, Supplier Evaluation, Purchasing, Cross-functional Team..., Global Sourcing, Procurement, Kaizen, ISO, Quality Management, Production Planning, 5S, Supplier Quality, Quality System, Kanban, Supply Chain Management, Root Cause Analysis
Education
Lesley University 1987 — 1989
Master of Business Administration (M.B.A.)
University of Puerto Rico-Mayaguez 1974 — 1977
Bachelor, Business Adm. Finance
University of Puerto Rico Ponce 1972 — 1974
Associate, Computer Programming
Reynaldo Reyes's Cordis Corporation Experience May 1998 - June 2010
Job
Industry Pharmaceuticals
Experience
Quest Diagnostics August 2010 - November 2012
Cordis Corporation May 1998 - June 2010
Johnson & Johnson July 1995 - May 1998
Ethicon May 1994 - June 1995
Skills
Industrial Hygiene, Hazardous Materials..., Business Continuity, Six Sigma, Ergonomics, IATA, Workers Compensation, ISO 14001, Integrated Management..., Training & Development, System Design, Risk Management, Strategic Planning, Sustainable Development, Product Stewardship, Compliance Audits, Environmental Management, Environmental Impact..., Quality Auditing, Occupational Health, Environmental..., Safety Management..., EHS, GMP, Leadership, Training, Process Improvement, Program Management, Environmental Awareness, Sustainability, Auditing, Hazardous Waste..., Employee Training
Education
University of Maryland College Park 2007 — 2009
MBA
Purdue University 1988 — 1993
B.S.
Quest Diagnostics August 2010 - November 2012
Cordis Corporation May 1998 - June 2010
Johnson & Johnson July 1995 - May 1998
Ethicon May 1994 - June 1995
Skills
Industrial Hygiene, Hazardous Materials..., Business Continuity, Six Sigma, Ergonomics, IATA, Workers Compensation, ISO 14001, Integrated Management..., Training & Development, System Design, Risk Management, Strategic Planning, Sustainable Development, Product Stewardship, Compliance Audits, Environmental Management, Environmental Impact..., Quality Auditing, Occupational Health, Environmental..., Safety Management..., EHS, GMP, Leadership, Training, Process Improvement, Program Management, Environmental Awareness, Sustainability, Auditing, Hazardous Waste..., Employee Training
Education
University of Maryland College Park 2007 — 2009
MBA
Purdue University 1988 — 1993
B.S.
Matt Mozur's Cordis Corporation Experience July 1978 - June 1981
Job Engineering Manager Electrical Hardware Group at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc April 2011 - Present
HeartWare Inc March 2009 - May 2011
TransMedics, Inc. April 2006 - February 2009
Draeger Medical Systems 2004 - 2006
Siemens Medical Systems July 1986 - July 2004
Analogic May 1984 - July 1986
Norland Corporation June 1981 - May 1984
Cordis Corporation July 1978 - June 1981
Skills
Medical Devices, Engineering, PCB design, Troubleshooting, Electrical Engineering, Design Control, FMEA, ISO 13485, ISO 14971, Project Management, Testing, R&D, Quality Assurance, GMP, V&V, CAD, Electronics, Medical Monitoring, Analog, Cross-functional Team..., CAPA, PCB Design
Education
Duke University 1974 — 1978
BSE, Biomedical Engineering/Electrical Engineering
HeartWare Inc April 2011 - Present
HeartWare Inc March 2009 - May 2011
TransMedics, Inc. April 2006 - February 2009
Draeger Medical Systems 2004 - 2006
Siemens Medical Systems July 1986 - July 2004
Analogic May 1984 - July 1986
Norland Corporation June 1981 - May 1984
Cordis Corporation July 1978 - June 1981
Skills
Medical Devices, Engineering, PCB design, Troubleshooting, Electrical Engineering, Design Control, FMEA, ISO 13485, ISO 14971, Project Management, Testing, R&D, Quality Assurance, GMP, V&V, CAD, Electronics, Medical Monitoring, Analog, Cross-functional Team..., CAPA, PCB Design
Education
Duke University 1974 — 1978
BSE, Biomedical Engineering/Electrical Engineering
Carole Cavicchi's Cordis Corporation Experience March 2004 - July 2007
Job Senior Associate, Global Competitive Intelligence at Merck & Company, Inc.
Industry Pharmaceuticals
Experience
Merck & Company, Inc. November 2012 - Present
Telerx, a Division of Merck August 2011 - November 2012
Mitsubishi Tanabe Pharmaceutical Development America, Inc. August 2009 - August 2011
Kelly Services August 2007 - August 2009
Cordis Corporation March 2004 - July 2007
GPC Biotech 2007 - 2007
Pharmaceutical Sourcing Group Americas February 2003 - March 2004
Janssen Pharmaceutica, Inc February 1996 - February 2003
Chanel, Inc June 1993 - February 1996
Skills
FDA, Pharmaceutical Industry, Quality Assurance, Analysis, Market Research, Product Development, GMP, Validation, Medical Devices, Cross-functional Team..., 21 CFR Part 11
Education
College of St. Elizabeth
Business Management
New Jersey City University
Geology
Merck & Company, Inc. November 2012 - Present
Telerx, a Division of Merck August 2011 - November 2012
Mitsubishi Tanabe Pharmaceutical Development America, Inc. August 2009 - August 2011
Kelly Services August 2007 - August 2009
Cordis Corporation March 2004 - July 2007
GPC Biotech 2007 - 2007
Pharmaceutical Sourcing Group Americas February 2003 - March 2004
Janssen Pharmaceutica, Inc February 1996 - February 2003
Chanel, Inc June 1993 - February 1996
Skills
FDA, Pharmaceutical Industry, Quality Assurance, Analysis, Market Research, Product Development, GMP, Validation, Medical Devices, Cross-functional Team..., 21 CFR Part 11
Education
College of St. Elizabeth
Business Management
New Jersey City University
Geology
Ken Newton's Cordis Corporation Experience 1981 - 1987
Job Computational Physics at Agilent Labs
Industry Research
Experience
Agilent Technologies February 2004 - Present
Varian, Inc. 2004 - 2010
Hyperion Inc 2002 - 2004
Coulter Corporation 1998 - 2002
Small Parts Inc. 1994 - 1995
Johnson and Johnson Medical 1992 - 1994
Mississippi State University 1988 - 1992
Cordis Corporation 1981 - 1987
Skills
Optimization, Instrument Control, Programming, Modeling, Simulation, C++, Algorithms, Software Development, Data Acquisition, Mass Spectrometry, R&D, Simulations, Instrumentation, LC-MS, GC-MS, Medical Devices, Physics, Image Processing, Laboratory, Signal Processing, Machine Learning, Matlab
Education
Columbia University in the City of New York 1977 — 1981
Ph.D., Chemical Physics
University of Texas at Austin 1974 — 1977
M.A., Physics
Rice University 1970 — 1974
BA, Physics
Agilent Technologies February 2004 - Present
Varian, Inc. 2004 - 2010
Hyperion Inc 2002 - 2004
Coulter Corporation 1998 - 2002
Small Parts Inc. 1994 - 1995
Johnson and Johnson Medical 1992 - 1994
Mississippi State University 1988 - 1992
Cordis Corporation 1981 - 1987
Skills
Optimization, Instrument Control, Programming, Modeling, Simulation, C++, Algorithms, Software Development, Data Acquisition, Mass Spectrometry, R&D, Simulations, Instrumentation, LC-MS, GC-MS, Medical Devices, Physics, Image Processing, Laboratory, Signal Processing, Machine Learning, Matlab
Education
Columbia University in the City of New York 1977 — 1981
Ph.D., Chemical Physics
University of Texas at Austin 1974 — 1977
M.A., Physics
Rice University 1970 — 1974
BA, Physics
Gerry Ocando's Cordis Corporation Experience Staff New Product Development QA EngineerCordis Corporation a Johnson and Johnson company2001 - Present
Job Staff Quality Engineer at Cordis Corporation
Industry Medical Devices
Experience
Cordis Corporation Staff New Product Development QA EngineerCordis Corporation a Johnson and Johnson company2001 - Present
Education
Georgia Institute of Technology 1978 — 1981
Cordis Corporation Staff New Product Development QA EngineerCordis Corporation a Johnson and Johnson company2001 - Present
Education
Georgia Institute of Technology 1978 — 1981
Susan Kusek's Cordis Corporation Experience February 2002 - January 2007
Job Director, Clinical Operations at Orion Clinical Research
Industry Pharmaceuticals
Experience
Orion Clinical Research January 2007 - Present
Cordis Corporation February 2002 - January 2007
Cordis - A Johnson and Johnson Company 2002 - 2007
Education
Capella University 2006 — 2008
Orion Clinical Research January 2007 - Present
Cordis Corporation February 2002 - January 2007
Cordis - A Johnson and Johnson Company 2002 - 2007
Education
Capella University 2006 — 2008
Asha Marathe's Cordis Corporation Experience July 2006 - June 2009
Job Manager, Quality Engineering at Edwards Lifesciences
Industry Medical Devices
Experience
Edwards Lifesciences August 2014 - Present
Edwards Lifesciences March 2013 - August 2014
Edwards Lifesciences August 2010 - March 2013
Edwards Lifesciences June 2009 - August 2010
Cordis Corporation July 2006 - June 2009
Cordis Corporation - a Johnson&Johnson Company June 2005 - August 2005
Johnson&Johnson Consumer Products Company June 2004 - August 2004
Johnson&Johnson Consumer Products Company June 2003 - August 2003
Skills
FMEA, Product Development, GMP, Manufacturing, Process Engineering
Education
Cornell University 2005 — 2006
M.Eng, Biomedical Engineering
Cornell University 2001 — 2005
B.S, Chemical Engineering
Edwards Lifesciences August 2014 - Present
Edwards Lifesciences March 2013 - August 2014
Edwards Lifesciences August 2010 - March 2013
Edwards Lifesciences June 2009 - August 2010
Cordis Corporation July 2006 - June 2009
Cordis Corporation - a Johnson&Johnson Company June 2005 - August 2005
Johnson&Johnson Consumer Products Company June 2004 - August 2004
Johnson&Johnson Consumer Products Company June 2003 - August 2003
Skills
FMEA, Product Development, GMP, Manufacturing, Process Engineering
Education
Cornell University 2005 — 2006
M.Eng, Biomedical Engineering
Cornell University 2001 — 2005
B.S, Chemical Engineering
Gregory Kopia's Cordis Corporation Experience April 1997 - December 2007
Job Senior Medical Writer at PharmaWrite, LLC
Industry Pharmaceuticals
Experience
PharmaWrite, LLC June 2015 - Present
Kopia Consulting January 2008 - Present
Kopia Consulting 2008 - 2015
Cordis Corporation April 1997 - December 2007
Zynaxis Cell Science, Inc 1989 - 1995
GlaxoSmithKline 1987 - 1989
Skills
Drug Delivery, Medical Devices, FDA, Clinical Development, Patents, Pharmaceutics, Animal Models, Regulatory Submissions, Regulatory Affairs, Clinical Trials, Lifesciences, Biotechnology, R&D, CRO, Pharmaceutical Industry, GMP, Laboratory, Pharmacokinetics, Pharmacology, Cancer, Infectious Diseases, Technology Transfer, Oncology, Validation, Formulation, ISO 13485, Hardware Diagnostics, Sop, Cardiology, Life Sciences, SOP
Education
University of Michigan Medical School 1980 — 1983
Postdoctoral Fellow, Pharmacology
University of Medicine and Dentistry of New Jersey -New Jersey Medical School 1976 — 1980
Ph.D., Pharmacology
Gettysburg College 1967 — 1971
BA, Biology
PharmaWrite, LLC June 2015 - Present
Kopia Consulting January 2008 - Present
Kopia Consulting 2008 - 2015
Cordis Corporation April 1997 - December 2007
Zynaxis Cell Science, Inc 1989 - 1995
GlaxoSmithKline 1987 - 1989
Skills
Drug Delivery, Medical Devices, FDA, Clinical Development, Patents, Pharmaceutics, Animal Models, Regulatory Submissions, Regulatory Affairs, Clinical Trials, Lifesciences, Biotechnology, R&D, CRO, Pharmaceutical Industry, GMP, Laboratory, Pharmacokinetics, Pharmacology, Cancer, Infectious Diseases, Technology Transfer, Oncology, Validation, Formulation, ISO 13485, Hardware Diagnostics, Sop, Cardiology, Life Sciences, SOP
Education
University of Michigan Medical School 1980 — 1983
Postdoctoral Fellow, Pharmacology
University of Medicine and Dentistry of New Jersey -New Jersey Medical School 1976 — 1980
Ph.D., Pharmacology
Gettysburg College 1967 — 1971
BA, Biology
Felix Arbelo's Cordis Corporation Experience QA DirectorCordis - A Johnson and Johnson Company2003 - Present
Job Director QA at Cordis Corporation
Industry Medical Devices
Experience
Cordis Corporation QA DirectorCordis - A Johnson and Johnson Company2003 - Present
Cordis Corporation, a Johnson & Johnson Co. 2003 - Present
Cordis Europa 2003 - Present
Cordis, Johnson and Johnson 2003 - Present
Cordis de Mexico 2003 - Present
Cordis Neurovascular Inc., a Johnson & Johnson Co. 2003 - Present
Cordis Neurovascular, a Johnson and Johnson Company 2003 - Present
Cordis Europa N.V. (a Johnson & Johnson company) 2003 - Present
Cordis Corporation 2003 - Present
Johnson & Johnson 2003 - Present
Skills
Design Control, QSR, ISO 13485, Quality Systems, FDA, GMP, Process Validation, cGMP, Medical Devices, Quality Auditing, Quality Engineering, SOP, Validation, ISO, Supplier Quality, SPC, GxP, Quality Assurance, FMEA, Change Control, CAPA, 510 K, Quality Management, Lean Manufacturing, Six Sigma, Continuous Improvement, Kaizen, Root Cause Analysis, DOE, QC, CQE, Manufacturing, Supplier, 5S, Minitab, Process Improvement
Education
Florida International University
Cordis Corporation QA DirectorCordis - A Johnson and Johnson Company2003 - Present
Cordis Corporation, a Johnson & Johnson Co. 2003 - Present
Cordis Europa 2003 - Present
Cordis, Johnson and Johnson 2003 - Present
Cordis de Mexico 2003 - Present
Cordis Neurovascular Inc., a Johnson & Johnson Co. 2003 - Present
Cordis Neurovascular, a Johnson and Johnson Company 2003 - Present
Cordis Europa N.V. (a Johnson & Johnson company) 2003 - Present
Cordis Corporation 2003 - Present
Johnson & Johnson 2003 - Present
Skills
Design Control, QSR, ISO 13485, Quality Systems, FDA, GMP, Process Validation, cGMP, Medical Devices, Quality Auditing, Quality Engineering, SOP, Validation, ISO, Supplier Quality, SPC, GxP, Quality Assurance, FMEA, Change Control, CAPA, 510 K, Quality Management, Lean Manufacturing, Six Sigma, Continuous Improvement, Kaizen, Root Cause Analysis, DOE, QC, CQE, Manufacturing, Supplier, 5S, Minitab, Process Improvement
Education
Florida International University
Gordon Hoath's Cordis Corporation Experience October 2005 - December 2008
Job Consultant at Gordon W. Hoath, LLC
Industry Medical Devices
Experience
Gordon W. Hoath, LLC March 2009 - Present
Cordis Corporation October 2005 - December 2008
Cordis, Johnson & Johnson October 2005 - December 2008
Cordis Corporation a Johnson and Johnson company October 2005 - December 2008
Cordis - A Johnson and Johnson Company October 2005 - December 2008
LifeScan 2001 - 2005
LifeScan (Johnson & Johnson) 2001 - 2005
LifeScan, Inc Johnson and Johnson 2001 - 2005
Ethicon Endo-Surgery, Inc. 1997 - 2001
Baxter Healthcare 1990 - 1993
Education
California State University-Los Angeles 1990 — 1996
Gordon W. Hoath, LLC March 2009 - Present
Cordis Corporation October 2005 - December 2008
Cordis, Johnson & Johnson October 2005 - December 2008
Cordis Corporation a Johnson and Johnson company October 2005 - December 2008
Cordis - A Johnson and Johnson Company October 2005 - December 2008
LifeScan 2001 - 2005
LifeScan (Johnson & Johnson) 2001 - 2005
LifeScan, Inc Johnson and Johnson 2001 - 2005
Ethicon Endo-Surgery, Inc. 1997 - 2001
Baxter Healthcare 1990 - 1993
Education
California State University-Los Angeles 1990 — 1996
Carole (Gahafer) Roth, SPHR's Cordis Corporation Experience 2007 - 2009
Job Director Human Resources at Cardinal Health
Industry Medical Devices
Experience
Cardinal Health May 2014 - Present
AccessClosure, Inc. July 2013 - May 2014
AccessClosure, Inc. August 2009 - June 2013
Cordis Corporation 2007 - 2009
Conor Medsystems December 2004 - January 2007
Nitinol Devices & Components 2004 - 2004
ALZA Corporation 1997 - 2004
Skills
Employee Relations, Performance Management, Compensation, HRIS, Medical Devices, Talent Management, Organizational..., Deferred Compensation, Change Management, Leadership, Human Resources, Coaching, Start-ups, Temporary Placement, Team Building, Succession Planning, Onboarding, Talent Acquisition, Applicant Tracking..., Recruiting, Workforce Planning, Employee Engagement, Organizational...
Education
California Polytechnic State University-San Luis Obispo 1994 — 1997
Cardinal Health May 2014 - Present
AccessClosure, Inc. July 2013 - May 2014
AccessClosure, Inc. August 2009 - June 2013
Cordis Corporation 2007 - 2009
Conor Medsystems December 2004 - January 2007
Nitinol Devices & Components 2004 - 2004
ALZA Corporation 1997 - 2004
Skills
Employee Relations, Performance Management, Compensation, HRIS, Medical Devices, Talent Management, Organizational..., Deferred Compensation, Change Management, Leadership, Human Resources, Coaching, Start-ups, Temporary Placement, Team Building, Succession Planning, Onboarding, Talent Acquisition, Applicant Tracking..., Recruiting, Workforce Planning, Employee Engagement, Organizational...
Education
California Polytechnic State University-San Luis Obispo 1994 — 1997
Sidnia Uriarte's Cordis Corporation Experience February 2001 - July 2004
Job R&D Technician at Cordis Neurovascular
Industry Medical Devices
Experience
Cordis Neurovascular a Johnson & Johnson Company July 2004 - Present
Cordis Corporation February 2001 - July 2004
Cordis Corporation May 1996 - February 2000
Education
Miami Dade College
Cordis Neurovascular a Johnson & Johnson Company July 2004 - Present
Cordis Corporation February 2001 - July 2004
Cordis Corporation May 1996 - February 2000
Education
Miami Dade College
Virgil Ellsworth's Cordis Corporation Experience 2006 - 2009
Job Sr QA Manager at Advanced Bionics
Industry Medical Devices
Experience
Advanced Bionics September 2014 - Present
Cordis Corporation, a Johnson and Johnson Co. 2005 - Present
TE Connectivity December 2011 - July 2014
BWI August 2008 - December 2011
Biosense Webster 2008 - December 2011
Cordis Corporation 2006 - 2009
Cordis, a Johnson & Johnson Company June 2007 - September 2008
Cordis Neurovascular, a Johnson and Johnson Company 2006 - 2008
Nitinol Devices & Components 2004 - 2006
NDC - Nitinol Devices and Components 2004 - 2005
Skills
FDA, CAPA, Quality System, Quality Assurance, Medical Devices, ISO 13485, Validation, Design Control, V&V, GMP, Product Development, Cross-functional Team..., FMEA, Auditing, Six Sigma, Minitab, GxP, Software Quality..., Project Management
Education
San Jose State University 1979 — 1982
Bachelor of Arts (B.A.), Biology, General
San Jose State University
Bachelor's degree, Molecular Biology
Advanced Bionics September 2014 - Present
Cordis Corporation, a Johnson and Johnson Co. 2005 - Present
TE Connectivity December 2011 - July 2014
BWI August 2008 - December 2011
Biosense Webster 2008 - December 2011
Cordis Corporation 2006 - 2009
Cordis, a Johnson & Johnson Company June 2007 - September 2008
Cordis Neurovascular, a Johnson and Johnson Company 2006 - 2008
Nitinol Devices & Components 2004 - 2006
NDC - Nitinol Devices and Components 2004 - 2005
Skills
FDA, CAPA, Quality System, Quality Assurance, Medical Devices, ISO 13485, Validation, Design Control, V&V, GMP, Product Development, Cross-functional Team..., FMEA, Auditing, Six Sigma, Minitab, GxP, Software Quality..., Project Management
Education
San Jose State University 1979 — 1982
Bachelor of Arts (B.A.), Biology, General
San Jose State University
Bachelor's degree, Molecular Biology
Marina D'Souza Marina's Cordis Corporation Experience 2001 - Present
Job Medical Devices Professional
Industry Medical Devices
Experience
Cordis Corporation 2001 - Present
Education
Bangalore University
Cordis Corporation 2001 - Present
Education
Bangalore University
George L. Lara's Cordis Corporation Experience October 1998 - June 2005
Job Sr Quality Associate
Industry Medical Devices
Experience
Codman July 2013 - Present
Safestitch Medical January 2012 - June 2012
JOHNSON and JOHNSON – CORDIS CORPORATION October 1995 - August 2011
Cordis Corporation October 1998 - June 2005
TELECTRONIC PACING SYSTEM January 1994 - January 1995
Skills
Validation, Software Installation, ISO 13485, Medical Devices, FDA, Design Control, Quality System, Design of Experiments, Calibration, GMP, Minitab, Biomedical Engineering, R&D, CompTIA A+ Certification, ADAPTIV PLM..., Testing, Quality Control, Manufacturing, Process Improvement, Six Sigma, Software Documentation, Product Development, DMAIC, Electronics, Engineering, FMEA, ISO 14971, SPC, Quality Assurance, Root Cause Analysis
Education
Miami Dade College 1998 — 2000
AS, Electronics Engineering Technology
Passaic school of drafting 1990 — 1992
Electro/mechanical draftsman, Electrical and mechanical drafting
Codman July 2013 - Present
Safestitch Medical January 2012 - June 2012
JOHNSON and JOHNSON – CORDIS CORPORATION October 1995 - August 2011
Cordis Corporation October 1998 - June 2005
TELECTRONIC PACING SYSTEM January 1994 - January 1995
Skills
Validation, Software Installation, ISO 13485, Medical Devices, FDA, Design Control, Quality System, Design of Experiments, Calibration, GMP, Minitab, Biomedical Engineering, R&D, CompTIA A+ Certification, ADAPTIV PLM..., Testing, Quality Control, Manufacturing, Process Improvement, Six Sigma, Software Documentation, Product Development, DMAIC, Electronics, Engineering, FMEA, ISO 14971, SPC, Quality Assurance, Root Cause Analysis
Education
Miami Dade College 1998 — 2000
AS, Electronics Engineering Technology
Passaic school of drafting 1990 — 1992
Electro/mechanical draftsman, Electrical and mechanical drafting
Frank Butaric's Cordis Corporation Experience 1992 - 2007
Job Principal tecnician at Cordis
Industry Medical Devices
Experience
Heartware Inc. January 2008 - Present
Cordis Corporation, a Johnson & Johnson Company 1992 - Present
Johnson & Johnson 1992 - Present
Johnson & Johnson - Cordis Division March 1992 - October 2007
Cordis Corporation 1992 - 2007
Eastern Air Lines October 1976 - March 1989
Education
Broward College 1989 — 1993
Heartware Inc. January 2008 - Present
Cordis Corporation, a Johnson & Johnson Company 1992 - Present
Johnson & Johnson 1992 - Present
Johnson & Johnson - Cordis Division March 1992 - October 2007
Cordis Corporation 1992 - 2007
Eastern Air Lines October 1976 - March 1989
Education
Broward College 1989 — 1993
Garrick Horner's Cordis Corporation Experience December 2007 - Present
Job Research Specialist II at Cordis Corporation
Industry Research
Experience
Cordis Corporation December 2007 - Present
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY 1999 - January 2006
Education
Miami Dade College
Cordis Corporation December 2007 - Present
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY 1999 - January 2006
Education
Miami Dade College
Mark Swaby's Cordis Corporation Experience November 2006 - Present
Job Entrepreneur. Photography, Graphic Design, Web Design and Motion Graphics.
Industry Marketing and Advertising
Experience
Afflicted Pixels Studios, llc January 2013 - Present
Cordis Corporation November 2006 - Present
Cordis Corporation November 2006 - Present
Salomon Smith Barney / Citigroup October 2000 - March 2002
Skills
Web Design, Graphics, Photography, Adobe Creative Suite, Layout, Mac, Packaging, Image Manipulation, User Interface Design, Motion Graphics, Advertising, CSS, HTML 5, Video Editing, jQuery, Graphic Design, Illustrator, Project Management, Logo Design, Adobe Acrobat, Dreamweaver, Brochures, Flash, Corporate Branding, InDesign, User Experience, Photoshop, Branding, Typography, Art Direction, Corporate Identity, After Effects
Education
Digital Media Arts College 2008 — 2010
Bachelor of Arts (B.A.), Graphic Design
Digital Media Arts College 2007 — 2010
Bachelor, Graphic Design
Afflicted Pixels Studios, llc January 2013 - Present
Cordis Corporation November 2006 - Present
Cordis Corporation November 2006 - Present
Salomon Smith Barney / Citigroup October 2000 - March 2002
Skills
Web Design, Graphics, Photography, Adobe Creative Suite, Layout, Mac, Packaging, Image Manipulation, User Interface Design, Motion Graphics, Advertising, CSS, HTML 5, Video Editing, jQuery, Graphic Design, Illustrator, Project Management, Logo Design, Adobe Acrobat, Dreamweaver, Brochures, Flash, Corporate Branding, InDesign, User Experience, Photoshop, Branding, Typography, Art Direction, Corporate Identity, After Effects
Education
Digital Media Arts College 2008 — 2010
Bachelor of Arts (B.A.), Graphic Design
Digital Media Arts College 2007 — 2010
Bachelor, Graphic Design
Erica Cofino's Cordis Corporation Experience 2000 - Present
Job Sr. Admin Assit at Cordis Johnson & Johnson
Industry Medical Devices
Experience
Cordis Johnson & Johnson Sr. Administrative AssitCordis Corporation a Johnson and Johnson Company2000 - Present
Cordis Corporation 2000 - Present
Education
Nova Southeastern University 2003 — 2008
Cordis Johnson & Johnson Sr. Administrative AssitCordis Corporation a Johnson and Johnson Company2000 - Present
Cordis Corporation 2000 - Present
Education
Nova Southeastern University 2003 — 2008
Ramesh Marrey's Cordis Corporation Experience 2008 - Present
Job Engineering Fellow at Cordis Corporation
Industry Medical Devices
Experience
Cordis Corporation 2008 - Present
Cordis 2004 - 2008
Cordis 2001 - 2004
Advance USA 1996 - 2001
Skills
Biomaterials, Finite Element Analysis, Biomedical Engineering, Medical Devices, Design of Experiments, Design Control, Quality System, Six Sigma, Product Development, R&D, Validation, Program Management, FDA, ISO 13485, Solidworks, Commercialization, V&V, FMEA
Education
University of Florida 1995 — 1996
Post-doctoral Associate, Engineering Mechanics
University of Florida 1991 — 1995
PhD, Engineering Mechanics
University of Florida 1988 — 1991
MS, Engineering Mechanics
Indian Institute of Technology, Madras 1984 — 1988
B. Tech., Mechanical Engineering
Cordis Corporation 2008 - Present
Cordis 2004 - 2008
Cordis 2001 - 2004
Advance USA 1996 - 2001
Skills
Biomaterials, Finite Element Analysis, Biomedical Engineering, Medical Devices, Design of Experiments, Design Control, Quality System, Six Sigma, Product Development, R&D, Validation, Program Management, FDA, ISO 13485, Solidworks, Commercialization, V&V, FMEA
Education
University of Florida 1995 — 1996
Post-doctoral Associate, Engineering Mechanics
University of Florida 1991 — 1995
PhD, Engineering Mechanics
University of Florida 1988 — 1991
MS, Engineering Mechanics
Indian Institute of Technology, Madras 1984 — 1988
B. Tech., Mechanical Engineering
Gordon Hoath's Cordis Corporation Experience Principal Quality Engineer, New Product DevelopmentCordis a Johnson & Johnson Company2005 - Present
Job Principal Quality Engineer, New Product Development at Cordis Corporation
Industry Medical Devices
Experience
Cordis Corporation Principal Quality Engineer, New Product DevelopmentCordis a Johnson & Johnson Company2005 - Present
LifeScan 2001 - 2005
Education
California State University-Los Angeles 1981 — 1986
Cordis Corporation Principal Quality Engineer, New Product DevelopmentCordis a Johnson & Johnson Company2005 - Present
LifeScan 2001 - 2005
Education
California State University-Los Angeles 1981 — 1986
Deborah Berland Kaster's Cordis Corporation Experience June 1997 - August 1997
Job Independent Medical Devices Professional
Industry Medical Devices
Experience
DBK Consulting January 2008 - Present
Kyphon Inc. July 2003 - 2008
Piper Jaffray August 1998 - April 2003
Cordis Corporation June 1997 - August 1997
Coopers & Lybrand 1997 - 1997
JP Morgan August 1994 - July 1996
PricewaterhouseCoopers 1992 - 1994
Skills
Medical Devices, Strategy, Start-ups, Biotechnology, Business Development, Mergers, Business Strategy, Commercialization, Market Development, Product Management, Product Launch
Education
University of Pennsylvania - The Wharton School 1996 — 1998
MBA, Finance & Strategy
Cornell University 1988 — 1992
The Loomis Chaffee School 1984 — 1988
DBK Consulting January 2008 - Present
Kyphon Inc. July 2003 - 2008
Piper Jaffray August 1998 - April 2003
Cordis Corporation June 1997 - August 1997
Coopers & Lybrand 1997 - 1997
JP Morgan August 1994 - July 1996
PricewaterhouseCoopers 1992 - 1994
Skills
Medical Devices, Strategy, Start-ups, Biotechnology, Business Development, Mergers, Business Strategy, Commercialization, Market Development, Product Management, Product Launch
Education
University of Pennsylvania - The Wharton School 1996 — 1998
MBA, Finance & Strategy
Cornell University 1988 — 1992
The Loomis Chaffee School 1984 — 1988
Donna Marshall's Cordis Corporation Experience June 2009 - September 2012
Job Manager, Regulatory Affairs at Ethicon, Inc. a Johnson and Johnson company
Industry Medical Devices
Experience
Ethicon, Inc. a Johnson and Johnson Company September 2012 - Present
Johnson & Johnson 2009 - Present
Cordis Corporation June 2009 - September 2012
Cordis Corp March 2006 - May 2009
Cordis Corporation (Johnson & Johnson) March 2002 - February 2006
Cordis March 1997 - February 2002
Skills
Regulations, Regulatory Affairs, Healthcare, PMA, ISO 13485, Validation, FDA, CAPA, Medical Devices, Design Control, Process Improvement, Regulatory Submissions, Cross-functional Team..., Product Launch, ISO 14971
Education
Caldwell University 2002 — 2008
Ethicon, Inc. a Johnson and Johnson Company September 2012 - Present
Johnson & Johnson 2009 - Present
Cordis Corporation June 2009 - September 2012
Cordis Corp March 2006 - May 2009
Cordis Corporation (Johnson & Johnson) March 2002 - February 2006
Cordis March 1997 - February 2002
Skills
Regulations, Regulatory Affairs, Healthcare, PMA, ISO 13485, Validation, FDA, CAPA, Medical Devices, Design Control, Process Improvement, Regulatory Submissions, Cross-functional Team..., Product Launch, ISO 14971
Education
Caldwell University 2002 — 2008
Timothy Kiorpes's Cordis Corporation Experience August 2000 - December 2007
Job President at Hunt Field Associates, LLC
Industry Medical Devices
Experience
Hunt Field Associates, LLC 2009 - Present
Cordis Corporation August 2000 - December 2007
Johnson & Johnson November 1981 - December 2007
Skills
R&D, Drug Discovery, Medical Devices, Strategy, Business Development, Biomedical Engineering, Product Launch
Education
Massachusetts Institute of Technology 1968 — 1978
SB, SM, PhD, Biology (Physics minor), Biochemistry & Metabolism
Hunt Field Associates, LLC 2009 - Present
Cordis Corporation August 2000 - December 2007
Johnson & Johnson November 1981 - December 2007
Skills
R&D, Drug Discovery, Medical Devices, Strategy, Business Development, Biomedical Engineering, Product Launch
Education
Massachusetts Institute of Technology 1968 — 1978
SB, SM, PhD, Biology (Physics minor), Biochemistry & Metabolism
Mohan Jaglal's Cordis Corporation Experience August 1992 - March 2005
Job Inventory Manager at Healthy Meds Pharmacy
Industry Medical Devices
Experience
Healthy Meds Pharmacy September 2011 - Present
Cordis Corp, Johnson & Johnson 2005 - Present
Cordis Corporation August 1992 - March 2005
Texaco Trinidad Oil Refinery October 1985 - May 1989
Education
Florida A &Mechanical University 1999 — 2005
BS, Electronic Engineering
Miami Dade College 1996 — 1999
AS, Electrical Engineering
San Fernando Technical College 1985 — 1987
AS, Mechanical Engineering
Healthy Meds Pharmacy September 2011 - Present
Cordis Corp, Johnson & Johnson 2005 - Present
Cordis Corporation August 1992 - March 2005
Texaco Trinidad Oil Refinery October 1985 - May 1989
Education
Florida A &Mechanical University 1999 — 2005
BS, Electronic Engineering
Miami Dade College 1996 — 1999
AS, Electrical Engineering
San Fernando Technical College 1985 — 1987
AS, Mechanical Engineering
Jacqueline Romero Olson's Cordis Corporation Experience July 2008 - November 2009
Job Supply Chain Manager
Industry Medical Devices
Experience
CR Bard December 2011 - Present
CR Bard October 2009 - December 2011
Cordis Corporation July 2008 - November 2009
Cordis Corporation April 2007 - July 2008
Cordis Corpoation July 2005 - April 2007
GE June 2004 - August 2004
3M June 2003 - August 2003
Procter & Gamble May 2002 - July 2002
Skills
Six Sigma, Lean Manufacturing, Process Improvement, Supply Chain, Black Belt, Supply Chain Management, Minitab, DMAIC, Demand Planning, Value Stream Mapping, Supply Chain..., Continuous Improvement, Inventory Management, Excel, Cross-functional Team..., Supply Management, Design of Experiments, FDA, Root Cause Analysis, Engineering Management, Medical Devices, Manufacturing, Microsoft Excel, MRP, Kaizen, Quality System, ISO 13485, Operational Excellence
Education
Emory University - Goizueta Business School 2011 — 2012
MBA
Cornell University 2001 — 2005
BS, Mechanical Engineering
CR Bard December 2011 - Present
CR Bard October 2009 - December 2011
Cordis Corporation July 2008 - November 2009
Cordis Corporation April 2007 - July 2008
Cordis Corpoation July 2005 - April 2007
GE June 2004 - August 2004
3M June 2003 - August 2003
Procter & Gamble May 2002 - July 2002
Skills
Six Sigma, Lean Manufacturing, Process Improvement, Supply Chain, Black Belt, Supply Chain Management, Minitab, DMAIC, Demand Planning, Value Stream Mapping, Supply Chain..., Continuous Improvement, Inventory Management, Excel, Cross-functional Team..., Supply Management, Design of Experiments, FDA, Root Cause Analysis, Engineering Management, Medical Devices, Manufacturing, Microsoft Excel, MRP, Kaizen, Quality System, ISO 13485, Operational Excellence
Education
Emory University - Goizueta Business School 2011 — 2012
MBA
Cornell University 2001 — 2005
BS, Mechanical Engineering
Thomas Trotta's Cordis Corporation Experience Senior Engineering FellowCordis Corporation a Johnson & Johnson Company1982 - Present
Job Senior Engineering Fellow at Cordis Corporation
Industry Medical Devices
Experience
Cordis Corporation Senior Engineering FellowCordis Corporation a Johnson & Johnson Company1982 - Present
Education
Florida International University 1979 — 1982
Cordis Corporation Senior Engineering FellowCordis Corporation a Johnson & Johnson Company1982 - Present
Education
Florida International University 1979 — 1982
Cary Colom's Cordis Corporation Experience Sr. SCM Planning AnalystCordis, a Johnson & Johnson Company1998 - Present
Job Sr SCM Planning Analyst at Cordis Corporation
Industry Pharmaceuticals
Experience
Cordis Corporation Sr. SCM Planning AnalystCordis, a Johnson & Johnson Company1998 - Present
Cordis, Johnson & Johnson 1998 - 2008
Cordis Corporation a Johnson & Johnson Co. January 2004 - October 2006
Education
Barry University 1988 — 1990
Cordis Corporation Sr. SCM Planning AnalystCordis, a Johnson & Johnson Company1998 - Present
Cordis, Johnson & Johnson 1998 - 2008
Cordis Corporation a Johnson & Johnson Co. January 2004 - October 2006
Education
Barry University 1988 — 1990
Bipin Patel, ASQ CQE, CSSBB's Cordis Corporation Experience January 2006 - February 2007
Job Sr. Quality Engineer at Abbott Vascular
Industry Medical Devices
Experience
Abbott Vascular December 2011 - Present
Abbott Vascular November 2009 - December 2011
GE Healthcare March 2007 - November 2009
Cordis Corporation January 2006 - February 2007
Cordis Corporation May 2005 - December 2005
Skills
CAPA, ISO 13485, SPC, GMP, Six Sigma, Continuous Improvement, DMAIC, Biomedical Engineering, FMEA, ISO 14971, Design Control, PDCA, FDA, R&D, Design of Experiments, Validation, Change Control, Quality System, 21 CFR Part 11, DOE, Quality Systems, Quality Engineering, 21 CFR Part 820, Process Validation, ISO 25539, ISO 10555, TQM, TQC
Education
New Jersey Institute of Technology
MS, Biomedical Engineering
South Gujarat University
BE, Chemical Engineering
Abbott Vascular December 2011 - Present
Abbott Vascular November 2009 - December 2011
GE Healthcare March 2007 - November 2009
Cordis Corporation January 2006 - February 2007
Cordis Corporation May 2005 - December 2005
Skills
CAPA, ISO 13485, SPC, GMP, Six Sigma, Continuous Improvement, DMAIC, Biomedical Engineering, FMEA, ISO 14971, Design Control, PDCA, FDA, R&D, Design of Experiments, Validation, Change Control, Quality System, 21 CFR Part 11, DOE, Quality Systems, Quality Engineering, 21 CFR Part 820, Process Validation, ISO 25539, ISO 10555, TQM, TQC
Education
New Jersey Institute of Technology
MS, Biomedical Engineering
South Gujarat University
BE, Chemical Engineering
Hildy Vila's Cordis Corporation Experience Sr. Administrative AssistantCordis - A Johnson and Johnson Company1989 - Present
Job Executive Administrative Assistant at Cordis, Johnson & Johnson
Industry Medical Devices
Experience
Cordis Corporation Sr. Administrative AssistantCordis - A Johnson and Johnson Company1989 - Present
Cordis, Johnson & Johnson 1989 - Present
Education
Miami Dade College 1993 — 1995
Cordis Corporation Sr. Administrative AssistantCordis - A Johnson and Johnson Company1989 - Present
Cordis, Johnson & Johnson 1989 - Present
Education
Miami Dade College 1993 — 1995
Evelyn Armstrong's Cordis Corporation Experience January 2003 - Present
Job Regulatory Affairs Associate at Cordis
Industry Medical Devices
Dennis Griffin's Cordis Corporation Experience 1997 - 1998
Job Regulatory Affairs
Industry Medical Devices
Experience
Regulatory Consultant January 2014 - Present
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY 1998 - 2013
Cordis Corporation 1997 - 1998
Dade International 1996 - 1997
Skills
FDA, ISO 13485, Regulatory Affairs, Medical Devices, CAPA, Quality System, Validation, V&V, GMP, Regulatory Submissions, Combination Products, R&D, Clinical Trials, PMA
Education
Northeastern University
Bachelor of Science (BS), Biology
Regulatory Consultant January 2014 - Present
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY 1998 - 2013
Cordis Corporation 1997 - 1998
Dade International 1996 - 1997
Skills
FDA, ISO 13485, Regulatory Affairs, Medical Devices, CAPA, Quality System, Validation, V&V, GMP, Regulatory Submissions, Combination Products, R&D, Clinical Trials, PMA
Education
Northeastern University
Bachelor of Science (BS), Biology
Angella Adams's Cordis Corporation Experience August 2006 - July 2014
Job Advanced Sourcing & Innovation Manager at DePuy Synthes
Industry Medical Devices
Experience
DePuy Synthes July 2014 - Present
Cordis Corporation August 2006 - July 2014
Skills
Strategic Sourcing, Supply Management, MRP, Supply Chain, Supply Chain Management, Materials Management, Procurement, Six Sigma, Global Sourcing, Supply Chain..., Lean Manufacturing, Supplier Development, Continuous Improvement, Cross-functional Team..., Purchasing, Demand Planning, Supplier Evaluation, Value Stream Mapping
Education
Howard University 2004 — 2006
MBA, Supply Chain Management
DePuy Synthes July 2014 - Present
Cordis Corporation August 2006 - July 2014
Skills
Strategic Sourcing, Supply Management, MRP, Supply Chain, Supply Chain Management, Materials Management, Procurement, Six Sigma, Global Sourcing, Supply Chain..., Lean Manufacturing, Supplier Development, Continuous Improvement, Cross-functional Team..., Purchasing, Demand Planning, Supplier Evaluation, Value Stream Mapping
Education
Howard University 2004 — 2006
MBA, Supply Chain Management
Stephen Enos, RN's Cordis Corporation Experience 2002 - 2007
Job Director, Regulatory Affairs at Edwards Lifesciences
Industry Medical Devices
Experience
Edwards Lifesciences June 2013 - Present
Consultant March 2013 - June 2013
Somahlution, Inc. May 2012 - April 2013
Cordis 2007 - May 2012
Cordis Corporation 2002 - 2007
Cordis Corporation 1997 - 2002
Cordis Corporation 1995 - 1997
Schneider (USA) 1992 - 1995
Schneider (USA) 1990 - 1992
Duke University Medical Center 1980 - 1990
Skills
Strategic Planning, CTMS, Wound Care, Diabetes, Heart Failure, KOL development, Cardiovascular Disease, Change Control, Neurosurgery, Healthcare Industry, Medical Devices, Regulatory Affairs, FDA, CAPA, ISO 13485, Design Control, PMA, Regulatory Submissions, Clinical Research, Commercialization, Quality System, Cardiology, GMP, Sop, V&V, Clinical Trials, Validation, Clinical Development, Protocol, Regulatory Requirements, GCP, 21 CFR Part 11, ISO 14971
Education
Indiana University of Pennsylvania 1976 — 1980
BSN, Nursing
Edwards Lifesciences June 2013 - Present
Consultant March 2013 - June 2013
Somahlution, Inc. May 2012 - April 2013
Cordis 2007 - May 2012
Cordis Corporation 2002 - 2007
Cordis Corporation 1997 - 2002
Cordis Corporation 1995 - 1997
Schneider (USA) 1992 - 1995
Schneider (USA) 1990 - 1992
Duke University Medical Center 1980 - 1990
Skills
Strategic Planning, CTMS, Wound Care, Diabetes, Heart Failure, KOL development, Cardiovascular Disease, Change Control, Neurosurgery, Healthcare Industry, Medical Devices, Regulatory Affairs, FDA, CAPA, ISO 13485, Design Control, PMA, Regulatory Submissions, Clinical Research, Commercialization, Quality System, Cardiology, GMP, Sop, V&V, Clinical Trials, Validation, Clinical Development, Protocol, Regulatory Requirements, GCP, 21 CFR Part 11, ISO 14971
Education
Indiana University of Pennsylvania 1976 — 1980
BSN, Nursing
David Hochman's Cordis Corporation Experience January 2000 - Present
Job Documentation Specialist at Cordis Corporation
Industry Medical Devices
Experience
Cordis Corporation January 2000 - Present
Skills
FDA, Medical Devices, ISO 13485, CAPA, Design Control, 21 CFR Part 11, Regulatory Submissions, Change Control, Quality System, Regulatory Affairs, Computer System..., GMP, GxP, Customer Service, Quality Auditing
Education
Florida Metropolitan University 1994 — 1998
Bachelor of Business Administration (BBA), 3.80
Molly Goodman Academic High School 1971 — 1973
High School
Cordis Corporation January 2000 - Present
Skills
FDA, Medical Devices, ISO 13485, CAPA, Design Control, 21 CFR Part 11, Regulatory Submissions, Change Control, Quality System, Regulatory Affairs, Computer System..., GMP, GxP, Customer Service, Quality Auditing
Education
Florida Metropolitan University 1994 — 1998
Bachelor of Business Administration (BBA), 3.80
Molly Goodman Academic High School 1971 — 1973
High School
Veronica Deshazer's Cordis Corporation Experience December 2003 - June 2009
Job Principal Scientist
Industry Medical Devices
Experience
Cordis Corporation, Johnson &Johnson June 2009 - Present
Cordis Corporation December 2003 - June 2009
Skills
Medical Devices, GMP, FDA, V&V, Biomedical Engineering, Validation, CAPA, GLP, Sop, Regulatory Submissions, ISO 13485, Lifesciences, Regulatory Affairs, 21 CFR Part 11, Biotechnology, R&D, Quality System, Design Control, Aseptic Processing, GxP, Commercialization, FDA GMP, Chemistry, Computer System..., Microbiology, Technology Transfer
Education
Barry University 1996 — 1998
MS, Biomedical Science
Howard University 1982 — 1988
BS, Microbiology, Chemistry
Cordis Corporation, Johnson &Johnson June 2009 - Present
Cordis Corporation December 2003 - June 2009
Skills
Medical Devices, GMP, FDA, V&V, Biomedical Engineering, Validation, CAPA, GLP, Sop, Regulatory Submissions, ISO 13485, Lifesciences, Regulatory Affairs, 21 CFR Part 11, Biotechnology, R&D, Quality System, Design Control, Aseptic Processing, GxP, Commercialization, FDA GMP, Chemistry, Computer System..., Microbiology, Technology Transfer
Education
Barry University 1996 — 1998
MS, Biomedical Science
Howard University 1982 — 1988
BS, Microbiology, Chemistry
Rajesh Nathan's Cordis Corporation Experience December 2005 - Present
Job Consultant Project Lead at Cordis Corporation
Industry Medical Devices
Experience
Cordis Corporation December 2005 - Present
Skills
Medical Devices, Clinical Trials, FDA, Regulatory Affairs, Oncology, Clinical Development, Pharmaceutical Industry, CRO
Education
Columbia University College of Physicians and Surgeons 2004 — 2006
M.S., Human Nutrition
Rutgers University-New Brunswick 1995 — 1999
B.S., Biological Sciences
Cordis Corporation December 2005 - Present
Skills
Medical Devices, Clinical Trials, FDA, Regulatory Affairs, Oncology, Clinical Development, Pharmaceutical Industry, CRO
Education
Columbia University College of Physicians and Surgeons 2004 — 2006
M.S., Human Nutrition
Rutgers University-New Brunswick 1995 — 1999
B.S., Biological Sciences
Eric Penn's Cordis Corporation Experience 2005 - 2007
Job Retired at None
Industry Medical Devices
Experience
None January 2010 - Present
Cordis Corporation 2005 - 2007
Quintiles Consulting November 2005 - December 2006
Guidant Corp 1988 - 2004
ACS/GUIDANT 1988 - 2004
Advanced Cardiovascular Systems 1989 - 1995
Skills
Design Control, R&D, Process Simulation, FDA, CAPA, Medical Devices, V&V, ISO 13485, Validation, Quality System, 21 CFR Part 11, GMP, Regulatory Affairs
Education
Coventry University 1962 — 1967
1965
None January 2010 - Present
Cordis Corporation 2005 - 2007
Quintiles Consulting November 2005 - December 2006
Guidant Corp 1988 - 2004
ACS/GUIDANT 1988 - 2004
Advanced Cardiovascular Systems 1989 - 1995
Skills
Design Control, R&D, Process Simulation, FDA, CAPA, Medical Devices, V&V, ISO 13485, Validation, Quality System, 21 CFR Part 11, GMP, Regulatory Affairs
Education
Coventry University 1962 — 1967
1965
Jeffery Mark Shields's Cordis Corporation Experience March 1995 - January 2002
Job Supplier Validation Manager at Arthrex
Industry Medical Devices
Experience
Arthrex September 2012 - Present
Mako Surgical October 2011 - October 2012
Arthrex Inc June 2010 - October 2011
Watson Pharmaceutical Corporation June 2010 - June 2010
Manufacturing August 2008 - March 2010
Boston Scientific Corporation February 2003 - August 2008
Haier Corporation January 2002 - December 2002
Cordis Corporation March 1995 - January 2002
Hunter Douglas Corporation November 1993 - March 1995
Telectronics Pacing System July 1992 - November 1993
Skills
FMEA, CAPA, Manufacturing, Design Control, SPC, ISO 13485, Medical Devices, Injection Molding, Six Sigma, V&V, Validation, FDA, Engineering, Process Improvement, Lean Manufacturing, GMP, ISO 14971, Quality System, Product Development, Machine Tools, Minitab, Design of Experiments, Quality Assurance, 21 CFR, 5S, Change Control, Continuous Improvement, Gage R&R, Manufacturing..., R&D, Value Stream Mapping, FDA GMP, Kaizen, Solidworks, Design for Manufacturing, Root Cause Analysis, DMAIC, Manufacturing Operations, Process Capability, ISO, Quality Control, Quality Auditing, CQE, Quality Management, Process Simulation, Biomedical Engineering, Plastics, Supplier Quality, Sop, 21 CFR Part 11
Education
Illinois State University 1980 — 1984
BS, Industrial Technology (Plastics Processes)
Arthrex September 2012 - Present
Mako Surgical October 2011 - October 2012
Arthrex Inc June 2010 - October 2011
Watson Pharmaceutical Corporation June 2010 - June 2010
Manufacturing August 2008 - March 2010
Boston Scientific Corporation February 2003 - August 2008
Haier Corporation January 2002 - December 2002
Cordis Corporation March 1995 - January 2002
Hunter Douglas Corporation November 1993 - March 1995
Telectronics Pacing System July 1992 - November 1993
Skills
FMEA, CAPA, Manufacturing, Design Control, SPC, ISO 13485, Medical Devices, Injection Molding, Six Sigma, V&V, Validation, FDA, Engineering, Process Improvement, Lean Manufacturing, GMP, ISO 14971, Quality System, Product Development, Machine Tools, Minitab, Design of Experiments, Quality Assurance, 21 CFR, 5S, Change Control, Continuous Improvement, Gage R&R, Manufacturing..., R&D, Value Stream Mapping, FDA GMP, Kaizen, Solidworks, Design for Manufacturing, Root Cause Analysis, DMAIC, Manufacturing Operations, Process Capability, ISO, Quality Control, Quality Auditing, CQE, Quality Management, Process Simulation, Biomedical Engineering, Plastics, Supplier Quality, Sop, 21 CFR Part 11
Education
Illinois State University 1980 — 1984
BS, Industrial Technology (Plastics Processes)
Frank Lawrance's Cordis Corporation Experience TechnicianCordis Corporation
Job Technician at Cordis Corporation
Industry Medical Devices
Experience
Cordis Corporation TechnicianCordis Corporation
Education
Minnesota State University, Mankato
Cordis Corporation TechnicianCordis Corporation
Education
Minnesota State University, Mankato
Alvin Weinberg's Cordis Corporation Experience 1981 - 1987
Job Sr. Staff Scientist at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical May 1987 - Present
Cordis Corporation 1981 - 1987
Skills
Medical Devices, Design Control, Biomedical Engineering, Electronics, ISO 13485, Product Development, Failure Analysis, R&D, FDA, Validation, Design of Experiments, GMP, Electrophysiology, SPC, Quality System, Cross-functional Team..., FMEA
Education
Drexel University 1978 — 1981
MS, Biomedical Engineering
Vanderbilt University 1974 — 1978
BE, Electrical/Biomedical Engineering
St. Jude Medical May 1987 - Present
Cordis Corporation 1981 - 1987
Skills
Medical Devices, Design Control, Biomedical Engineering, Electronics, ISO 13485, Product Development, Failure Analysis, R&D, FDA, Validation, Design of Experiments, GMP, Electrophysiology, SPC, Quality System, Cross-functional Team..., FMEA
Education
Drexel University 1978 — 1981
MS, Biomedical Engineering
Vanderbilt University 1974 — 1978
BE, Electrical/Biomedical Engineering
Sean Abel's Cordis Corporation Experience 1995 - 2003
Job Senior Technical Operations Engineer at Beckman Coulter
Industry Medical Devices
Experience
Codman Neurovascular - DePuy Synthes - J&J October 2014 - Present
Beckman Coulter October 2007 - October 2014
Boston Scientific 2004 - 2007
Cordis Corporation 1995 - 2003
Skills
Medical Devices, V&V, CAPA, FDA, Design Control, Design of Experiments, Biomedical Engineering, Validation, Quality System, ISO 14971, FMEA, 21 CFR, DMAIC, ISO 13485, Quality Control, Cross-functional Team..., Root Cause Analysis, Lean Manufacturing, SPC, Six Sigma, Manufacturing, ISO, R&D, Product Launch, Minitab, Gage R&R, Manufacturing..., Process Simulation, Product Development, GMP, Commercialization, Design for Manufacturing, Catheters, Process Capability, Failure Analysis, Manufacturing Operations, Value Stream Mapping, Kaizen, CE marking, GD&T, Continuous Improvement, FDA GMP, 5S, Supplier Quality, Tolerance Analysis, Medical Device R&D
Education
Florida International University 1999 — 2001
Masters of Science, Engineering Management
University of Miami 1991 — 1997
Bachelors of Science, Biomedical Engineering
Knox College 1982 — 1987
High School Diploma
Codman Neurovascular - DePuy Synthes - J&J October 2014 - Present
Beckman Coulter October 2007 - October 2014
Boston Scientific 2004 - 2007
Cordis Corporation 1995 - 2003
Skills
Medical Devices, V&V, CAPA, FDA, Design Control, Design of Experiments, Biomedical Engineering, Validation, Quality System, ISO 14971, FMEA, 21 CFR, DMAIC, ISO 13485, Quality Control, Cross-functional Team..., Root Cause Analysis, Lean Manufacturing, SPC, Six Sigma, Manufacturing, ISO, R&D, Product Launch, Minitab, Gage R&R, Manufacturing..., Process Simulation, Product Development, GMP, Commercialization, Design for Manufacturing, Catheters, Process Capability, Failure Analysis, Manufacturing Operations, Value Stream Mapping, Kaizen, CE marking, GD&T, Continuous Improvement, FDA GMP, 5S, Supplier Quality, Tolerance Analysis, Medical Device R&D
Education
Florida International University 1999 — 2001
Masters of Science, Engineering Management
University of Miami 1991 — 1997
Bachelors of Science, Biomedical Engineering
Knox College 1982 — 1987
High School Diploma
Balwinder Singh's Cordis Corporation Experience July 2007 - February 2012
Job Currently seeking an Opportunity
Industry Medical Devices
Experience
Acclarent Inc. a Johnson and Johnson Company May 2013 - June 2014
Procept BioRobotics 2014 - 2014
BSC/Stryker Corp October 2012 - May 2013
Cordis Corporation July 2007 - February 2012
NDC/Cordis Corp a J&J Company May 2001 - June 2007
eBusiness Solutions 2000 - 2001
Skills
CAPA, FDA, Medical Devices, Quality Assurance, Quality System, Six Sigma, Validation, Testing, Continuous Improvement, R&D, Software Documentation, ISO 13485, V&V, Design Control, FMEA, Cross-functional Team..., Design of Experiments
Education
Punjabi University
B. S., Math, Chemistry, Physics
Acclarent Inc. a Johnson and Johnson Company May 2013 - June 2014
Procept BioRobotics 2014 - 2014
BSC/Stryker Corp October 2012 - May 2013
Cordis Corporation July 2007 - February 2012
NDC/Cordis Corp a J&J Company May 2001 - June 2007
eBusiness Solutions 2000 - 2001
Skills
CAPA, FDA, Medical Devices, Quality Assurance, Quality System, Six Sigma, Validation, Testing, Continuous Improvement, R&D, Software Documentation, ISO 13485, V&V, Design Control, FMEA, Cross-functional Team..., Design of Experiments
Education
Punjabi University
B. S., Math, Chemistry, Physics
Elbita Bello's Cordis Corporation Experience May 2004 - December 2006
Job at Therakos, Inc
Industry Medical Devices
Experience
Orthoclinical Diagnostics, Johnson and Johnson April 2011 - Present
Therakos, Inc. December 2012 - May 2014
JOHNSON AND JOHNSON CONSUMER PRODUCTS January 2009 - December 2010
CAREMARK PHARMACY April 2007 - January 2008
CORDIS CORPORATION May 2004 - December 2006
NEIGHBORHOOD HEALTH PARTNERSHIP (NHP) January 1999 - January 2004
Skills
Six Sigma, Process Improvement, FDA, Quality System, GMP, Training, Quality Auditing, Medical Devices, Leadership, Program Management, Management, Sop, Quality Control, Risk Management, Manufacturing, Cross-functional Team..., Auditing
Education
Capella University
Bachelor of Science, Management and Leadership
MIAMI DADE COMMUNITY COLLEGE
Associate of Arts, Medical Studies
Orthoclinical Diagnostics, Johnson and Johnson April 2011 - Present
Therakos, Inc. December 2012 - May 2014
JOHNSON AND JOHNSON CONSUMER PRODUCTS January 2009 - December 2010
CAREMARK PHARMACY April 2007 - January 2008
CORDIS CORPORATION May 2004 - December 2006
NEIGHBORHOOD HEALTH PARTNERSHIP (NHP) January 1999 - January 2004
Skills
Six Sigma, Process Improvement, FDA, Quality System, GMP, Training, Quality Auditing, Medical Devices, Leadership, Program Management, Management, Sop, Quality Control, Risk Management, Manufacturing, Cross-functional Team..., Auditing
Education
Capella University
Bachelor of Science, Management and Leadership
MIAMI DADE COMMUNITY COLLEGE
Associate of Arts, Medical Studies
Walter Charles's Cordis Corporation Experience December 2004 - September 2010
Job Chief Procurement Officer at Biogen
Industry Hospital & Health Care
Experience
Biogen September 2015 - Present
Kraft Foods Group July 2014 - Present
Kellogg Company September 2012 - July 2014
Johnson & Johnson September 2010 - September 2012
Cordis Corporation December 2004 - September 2010
American Water October 2002 - December 2004
Bristol-Myers Squibb January 1999 - January 2002
Merck August 1991 - October 1999
Philadelphia Naval Shipyard August 1987 - August 1991
Skills
Strategic Sourcing, Procurement, Purchasing, Engineering, Medical Devices, Supply Chain, Contract Negotiations, Cross-functional Team..., Strategy Development, Start-ups, International Business, Cost Reduction, Vendor Relations, Business Strategy, Strategic Planning, Product Development, Licensing, Strategic Partnerships, New Business Development, Executive Management, P&L Management, Outsourcing, Manufacturing, Business Process..., Logistics, Change Management, Contract Negotiation, Program Management, Leadership, Process Improvement, Global Sourcing, Management, Strategy, Supply Chain Management, Negotiation, Lean Manufacturing, Team Building, Contract Management, Competitive Analysis, Six Sigma, Continuous Improvement, Operations Management, Vendor Management, Business Development, Sourcing, Project Management, Forecasting, Team Leadership, Sales, Budgets
Education
Columbia University - Columbia Business School 1998 — 2000
MBA, Business
Stevens Institute of Technology 1995 — 1997
ME, Environmental Engineering
United States Merchant Marine Academy 1982 — 1987
BS, Engineering
Biogen September 2015 - Present
Kraft Foods Group July 2014 - Present
Kellogg Company September 2012 - July 2014
Johnson & Johnson September 2010 - September 2012
Cordis Corporation December 2004 - September 2010
American Water October 2002 - December 2004
Bristol-Myers Squibb January 1999 - January 2002
Merck August 1991 - October 1999
Philadelphia Naval Shipyard August 1987 - August 1991
Skills
Strategic Sourcing, Procurement, Purchasing, Engineering, Medical Devices, Supply Chain, Contract Negotiations, Cross-functional Team..., Strategy Development, Start-ups, International Business, Cost Reduction, Vendor Relations, Business Strategy, Strategic Planning, Product Development, Licensing, Strategic Partnerships, New Business Development, Executive Management, P&L Management, Outsourcing, Manufacturing, Business Process..., Logistics, Change Management, Contract Negotiation, Program Management, Leadership, Process Improvement, Global Sourcing, Management, Strategy, Supply Chain Management, Negotiation, Lean Manufacturing, Team Building, Contract Management, Competitive Analysis, Six Sigma, Continuous Improvement, Operations Management, Vendor Management, Business Development, Sourcing, Project Management, Forecasting, Team Leadership, Sales, Budgets
Education
Columbia University - Columbia Business School 1998 — 2000
MBA, Business
Stevens Institute of Technology 1995 — 1997
ME, Environmental Engineering
United States Merchant Marine Academy 1982 — 1987
BS, Engineering
Vivian Perez, MBA, RAC's Cordis Corporation Experience August 2005 - October 2010
Job Regulatory Affairs Manager at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc November 2011 - Present
HeartWare Inc October 2010 - October 2011
Cordis Corporation August 2005 - October 2010
Cordis Corporation August 2001 - August 2005
Skills
Packaging, Medical Devices, FDA, Continuous Improvement, Cardiology, Regulatory Affairs
Education
Florida Atlantic University 2004 — 2006
Master, Business Administration
HeartWare Inc November 2011 - Present
HeartWare Inc October 2010 - October 2011
Cordis Corporation August 2005 - October 2010
Cordis Corporation August 2001 - August 2005
Skills
Packaging, Medical Devices, FDA, Continuous Improvement, Cardiology, Regulatory Affairs
Education
Florida Atlantic University 2004 — 2006
Master, Business Administration
Richard Acevedo's Cordis Corporation Experience June 1999 - December 2002
Job Engineering Manager at INSURGICAL Powered Instruments
Industry Medical Devices
Experience
INSURGICAL Powered Instruments January 2014 - Present
Integra LifeSciences September 2011 - November 2013
Ascension Orthopedics June 2008 - September 2011
Smith & Nephew Orthopaedics March 2004 - June 2008
Medsource Technologies January 2003 - January 2004
cordis corporation June 1999 - December 2002
Boston Scientific March 1993 - April 1999
Skills
Design Control, Medical Devices, FDA, Biomedical Engineering, ISO 13485, Orthopedic, V&V, Biomaterials, Quality System, CAPA, Product Development, Design for Manufacturing, ISO 14971, Biomechanics
Education
Florida International University 2000 — 2002
MSEM, Engineering Management
University of Florida 1986 — 1991
BSME, Mechanical Engineer
INSURGICAL Powered Instruments January 2014 - Present
Integra LifeSciences September 2011 - November 2013
Ascension Orthopedics June 2008 - September 2011
Smith & Nephew Orthopaedics March 2004 - June 2008
Medsource Technologies January 2003 - January 2004
cordis corporation June 1999 - December 2002
Boston Scientific March 1993 - April 1999
Skills
Design Control, Medical Devices, FDA, Biomedical Engineering, ISO 13485, Orthopedic, V&V, Biomaterials, Quality System, CAPA, Product Development, Design for Manufacturing, ISO 14971, Biomechanics
Education
Florida International University 2000 — 2002
MSEM, Engineering Management
University of Florida 1986 — 1991
BSME, Mechanical Engineer
James Patak's Cordis Corporation Experience 1990 - 1998
Job Project Manager at HeartWare Inc
Industry Medical Devices
Experience
HeartWare Inc January 2010 - Present
Southern Cross Professional Services January 1998 - January 2010
Invivo Corporation, a Philips Medical Systems Company May 2009 - December 2009
HeartWare Inc May 2008 - April 2009
NPE September 2008 - January 2009
Abbott Diagnostics 2007 - 2008
Trade Staffers Inc. February 2002 - 2007
Cordis Corporation, a Johnson and Johnson Company 1990 - 2004
Cordis September 1998 - January 2001
Cordis Corporation 1990 - 1998
Skills
Inventory Management, Medical Devices, CAPA, Design Control, ISO 13485, Quality System, FDA, Six Sigma, Cross-functional Team..., V&V, Product Development, Commercialization, Product Launch, Manufacturing, Pharmaceutical Industry, Quality Assurance, Validation, Regulatory Submissions, Change Control, Regulatory Affairs, Continuous Improvement, Testing, DMAIC, Root Cause Analysis, Design of Experiments, GMP, 21 CFR Part 11, Quality Control, ISO, R&D, Software Documentation, Minitab, Quality Auditing, Quality Management, FMEA, Biomedical Engineering, Process Simulation, Sop, SPC, Lean Manufacturing, Technology Transfer, Computer System..., Process Engineering, Design for Manufacturing, Biotechnology, CE marking, Manufacturing..., Clinical Trials, ISO 14971, Lifesciences
Education
New York Institute of Technology 1978 — 1981
BS, Engineering Technology
State University of New York - System 1975 — 1977
AAS, Veterinary Sciences
HeartWare Inc January 2010 - Present
Southern Cross Professional Services January 1998 - January 2010
Invivo Corporation, a Philips Medical Systems Company May 2009 - December 2009
HeartWare Inc May 2008 - April 2009
NPE September 2008 - January 2009
Abbott Diagnostics 2007 - 2008
Trade Staffers Inc. February 2002 - 2007
Cordis Corporation, a Johnson and Johnson Company 1990 - 2004
Cordis September 1998 - January 2001
Cordis Corporation 1990 - 1998
Skills
Inventory Management, Medical Devices, CAPA, Design Control, ISO 13485, Quality System, FDA, Six Sigma, Cross-functional Team..., V&V, Product Development, Commercialization, Product Launch, Manufacturing, Pharmaceutical Industry, Quality Assurance, Validation, Regulatory Submissions, Change Control, Regulatory Affairs, Continuous Improvement, Testing, DMAIC, Root Cause Analysis, Design of Experiments, GMP, 21 CFR Part 11, Quality Control, ISO, R&D, Software Documentation, Minitab, Quality Auditing, Quality Management, FMEA, Biomedical Engineering, Process Simulation, Sop, SPC, Lean Manufacturing, Technology Transfer, Computer System..., Process Engineering, Design for Manufacturing, Biotechnology, CE marking, Manufacturing..., Clinical Trials, ISO 14971, Lifesciences
Education
New York Institute of Technology 1978 — 1981
BS, Engineering Technology
State University of New York - System 1975 — 1977
AAS, Veterinary Sciences
Madeleine Valdes's Cordis Corporation Experience February 1993 - February 1996
Job Executive Assistant
Industry Food & Beverages
Experience
Covidien Pharmaceuticals June 2009 - December 2012
Cordis, Johnson & Johnson February 2002 - May 2009
Cordis Corporation, Johnson & Johnson February 1996 - January 2002
Cordis Corporation February 1993 - February 1996
Cordis Corporation January 1988 - February 1993
Skills
PeopleSoft, Lawson Desktop..., Detailed oriented, Customer Service focused, Organized, Decision Making, Employee Benefits, Employee Relations, Human Resources, Deferred Compensation, Succession Planning, HRIS, Talent Management, Confidentiality, New Hire Orientations, Leadership, Interviews, Management, Recruiting, College Recruiting, Cross-functional Team..., Onboarding, Benefits Administration, Customer Service
Education
Miami Dade College
Associate of Science (AS)
La Salle
Covidien Pharmaceuticals June 2009 - December 2012
Cordis, Johnson & Johnson February 2002 - May 2009
Cordis Corporation, Johnson & Johnson February 1996 - January 2002
Cordis Corporation February 1993 - February 1996
Cordis Corporation January 1988 - February 1993
Skills
PeopleSoft, Lawson Desktop..., Detailed oriented, Customer Service focused, Organized, Decision Making, Employee Benefits, Employee Relations, Human Resources, Deferred Compensation, Succession Planning, HRIS, Talent Management, Confidentiality, New Hire Orientations, Leadership, Interviews, Management, Recruiting, College Recruiting, Cross-functional Team..., Onboarding, Benefits Administration, Customer Service
Education
Miami Dade College
Associate of Science (AS)
La Salle
Humberto Galeana's Cordis Corporation Experience April 2002 - May 2005
Job Sr Finance Manager at Biosense Webster
Industry Medical Devices
Experience
Biosense Webster August 2011 - Present
Cordis May 2005 - August 2011
Cordis Corporation April 2002 - May 2005
Skills
Sarbanes-Oxley Act, JD Edwards, Financial Reporting, Process Improvement, Financial Analysis, Medical Devices, Auditing, Variance Analysis, Forecasting, Cross-functional Team..., Six Sigma, Cost Accounting, Financial Modeling, Internal Controls
Education
Nova Southeastern University 2003 — 2005
MBA, MIBA
ITESM 1994 — 1998
Bachelor, Accounting
Biosense Webster August 2011 - Present
Cordis May 2005 - August 2011
Cordis Corporation April 2002 - May 2005
Skills
Sarbanes-Oxley Act, JD Edwards, Financial Reporting, Process Improvement, Financial Analysis, Medical Devices, Auditing, Variance Analysis, Forecasting, Cross-functional Team..., Six Sigma, Cost Accounting, Financial Modeling, Internal Controls
Education
Nova Southeastern University 2003 — 2005
MBA, MIBA
ITESM 1994 — 1998
Bachelor, Accounting
James A. Foster (Jay)'s Cordis Corporation Experience May 1992 - August 2010
Job Documentation Specialist at Bellinson Law Firm
Industry Law Practice
Experience
Bellinson Law Firm October 2012 - Present
EmbroidMe-North Miami Beach October 2010 - May 2012
Cordis Corporation May 1992 - August 2010
Skills
Green Belt Certified in..., Extensive Managerial..., Trained and Experienced..., Expert in FDA, DEA,..., Team Building and..., Expert in Achieving...
Education
North Carolina Central University 1968 — 1972
BS in Commerce, Business Administration
Bellinson Law Firm October 2012 - Present
EmbroidMe-North Miami Beach October 2010 - May 2012
Cordis Corporation May 1992 - August 2010
Skills
Green Belt Certified in..., Extensive Managerial..., Trained and Experienced..., Expert in FDA, DEA,..., Team Building and..., Expert in Achieving...
Education
North Carolina Central University 1968 — 1972
BS in Commerce, Business Administration
Juan C. Diaz, RN, BA's Cordis Corporation Experience August 1998 - August 1999
Job Surgical Nurse at U.S. Department of Veterans Affairs
Industry Hospital & Health Care
Experience
U.S. Department of Veterans Affairs May 2015 - Present
Baptist Health South Florida March 2014 - Present
University of Miami July 2011 - August 2013
Merck 2006 - 2009
Interval International 1999 - 2006
Cordis Corporation August 1998 - August 1999
Rene Perez & Associates, Inc. August 1993 - August 1998
Skills
Nursing, Nursing Education, Hospitals, Operating Room, ICU, Surgery, Orthopedics, Robotics, DaVinci, Healthcare, Surgical Nursing, Pharmaceutical Sales, Critical Care, Healthcare Information..., Systems Analysis, Perioperative Nursing, Primary Care, Wound Care, ACLS Certification, Healthcare IT, SIS, Centricity, Meditech, Managed Care, Patient Safety, ACLS, Healthcare Management, Nursing Documentation, Software Documentation, Medical Terminology, Medical Software
Education
Miami Dade College - Medical Campus 2009 — 2011
Registeres Nurse, Registered Nurse
Florida International University - College of Business Administration 1995 — 1999
Bachelor's Degree, Finance, minor Chemistry & Economics
U.S. Department of Veterans Affairs May 2015 - Present
Baptist Health South Florida March 2014 - Present
University of Miami July 2011 - August 2013
Merck 2006 - 2009
Interval International 1999 - 2006
Cordis Corporation August 1998 - August 1999
Rene Perez & Associates, Inc. August 1993 - August 1998
Skills
Nursing, Nursing Education, Hospitals, Operating Room, ICU, Surgery, Orthopedics, Robotics, DaVinci, Healthcare, Surgical Nursing, Pharmaceutical Sales, Critical Care, Healthcare Information..., Systems Analysis, Perioperative Nursing, Primary Care, Wound Care, ACLS Certification, Healthcare IT, SIS, Centricity, Meditech, Managed Care, Patient Safety, ACLS, Healthcare Management, Nursing Documentation, Software Documentation, Medical Terminology, Medical Software
Education
Miami Dade College - Medical Campus 2009 — 2011
Registeres Nurse, Registered Nurse
Florida International University - College of Business Administration 1995 — 1999
Bachelor's Degree, Finance, minor Chemistry & Economics
Rick Hillstead's Cordis Corporation Experience 1986 - 1993
Job Medical Device Entrepreneur
Industry Medical Devices
Experience
Georgia Venture Partners June 2008 - Present
Richard A. Hillstead Inc. April 2008 - Present
Accuitive Medical Ventures I & II April 2007 - Present
Accuitive Medical Ventures I April 2004 - Present
Biofisica, Inc. May 2009 - January 2012
The Innovation Factory April 1999 - January 2008
Novoste Corporation April 1993 - April 1999
Cordis Corporation 1986 - 1993
Skills
Medical Devices, Venture Capital, Start-ups, Interventional..., Cross-functional Team..., Product Development, Design Control, Lifesciences, Leadership, Product Launch, FDA, Clinical Trials, Due Diligence, Orthopedic, GMP, Intellectual Property, Commercialization, ISO 13485, R&D, Life Sciences, Biotechnology, Biomedical Engineering
Education
Nova Southeastern University 1987 — 1992
BS, MBA, Ph.D., Engineering, Business
Nova Southeastern University
Georgia Venture Partners June 2008 - Present
Richard A. Hillstead Inc. April 2008 - Present
Accuitive Medical Ventures I & II April 2007 - Present
Accuitive Medical Ventures I April 2004 - Present
Biofisica, Inc. May 2009 - January 2012
The Innovation Factory April 1999 - January 2008
Novoste Corporation April 1993 - April 1999
Cordis Corporation 1986 - 1993
Skills
Medical Devices, Venture Capital, Start-ups, Interventional..., Cross-functional Team..., Product Development, Design Control, Lifesciences, Leadership, Product Launch, FDA, Clinical Trials, Due Diligence, Orthopedic, GMP, Intellectual Property, Commercialization, ISO 13485, R&D, Life Sciences, Biotechnology, Biomedical Engineering
Education
Nova Southeastern University 1987 — 1992
BS, MBA, Ph.D., Engineering, Business
Nova Southeastern University
Myra Diaz's Cordis Corporation Experience 1982 - April 2000
Job Senior Mgr. Compensation at Noven Pharmaceuticals
Industry Pharmaceuticals
Experience
Noven Pharmaceuticals May 2000 - Present
Noven Pharmaceuticals 2000 - 2009
Cordis Corporation 1982 - April 2000
Saxon Business Products 1972 - 1982
Saxon Business Products 1972 - 1982
Skills
Deferred Compensation, Payroll, HRIS, Succession Planning, Benefits Administration, Talent Management, Six Sigma, Compensation & Benefit, Process Improvement, Performance Management, Human Resources, Applicant Tracking..., Onboarding, Market Pricing, FLSA, New Hire Orientations, Employee Relations, Employee Benefits, Incentive Programs, HR Policies, Job Descriptions, Base Pay, Variable Pay, Pay Structures, Program Management, Organizational..., Pay for Performance, Recruiting, Talent Acquisition, Salary, Compensation Strategies, Job Pricing, 401k, Personnel Management, PowerPoint
Education
Nova Southeastern University
Business Administration and Management, General
Noven Pharmaceuticals May 2000 - Present
Noven Pharmaceuticals 2000 - 2009
Cordis Corporation 1982 - April 2000
Saxon Business Products 1972 - 1982
Saxon Business Products 1972 - 1982
Skills
Deferred Compensation, Payroll, HRIS, Succession Planning, Benefits Administration, Talent Management, Six Sigma, Compensation & Benefit, Process Improvement, Performance Management, Human Resources, Applicant Tracking..., Onboarding, Market Pricing, FLSA, New Hire Orientations, Employee Relations, Employee Benefits, Incentive Programs, HR Policies, Job Descriptions, Base Pay, Variable Pay, Pay Structures, Program Management, Organizational..., Pay for Performance, Recruiting, Talent Acquisition, Salary, Compensation Strategies, Job Pricing, 401k, Personnel Management, PowerPoint
Education
Nova Southeastern University
Business Administration and Management, General
Charles L. Shine's Cordis Corporation Experience 2012 - 2014
Job Revenue Analyst at Johnson & Johnson Consumer Inc.
Industry Consumer Goods
Experience
Johnson & Johnson Consumer Inc. 2014 - Present
Cordis Corporation 2012 - 2014
Johnson & Johnson Health Care Systems Inc. 2009 - 2012
Johnson & Johnson Sales And Logistics Company, LLC 2008 - 2009
Johnson & Johnson Sales And Logistics Company, LLC 2007 - 2008
Johnson & Johnson Sales And Logistics Company, LLC 2001 - 2007
Johnson & Johnson Sales And Logistics Company, LLC 1999 - 2001
Johnson & Johnson Health Care Systems Inc. 1996 - 1999
Skills
Medical Devices, Healthcare, Outlook, Process Improvement, Microsoft Excel, SAP, Access, Medicare, Pricing, Data Analysis, PowerPoint, Forecasting, Sales Operations, Analysis, Strategic Planning, Business Planning, Budgets, Teamwork, New Business Development, Sales Management, Team Building, Customer Service, SharePoint, Sales, Cross-functional Team..., Business Analysis, Negotiation, Microsoft Office, Project Planning, Inventory Management, Account Management, Time Management, Customer Satisfaction, Change Management, Coaching, Administration, Business Strategy, Business Development, Business Process...
Education
Kean University 1990 — 1995
BA, Physical Education/Adult Fitness
Johnson & Johnson Consumer Inc. 2014 - Present
Cordis Corporation 2012 - 2014
Johnson & Johnson Health Care Systems Inc. 2009 - 2012
Johnson & Johnson Sales And Logistics Company, LLC 2008 - 2009
Johnson & Johnson Sales And Logistics Company, LLC 2007 - 2008
Johnson & Johnson Sales And Logistics Company, LLC 2001 - 2007
Johnson & Johnson Sales And Logistics Company, LLC 1999 - 2001
Johnson & Johnson Health Care Systems Inc. 1996 - 1999
Skills
Medical Devices, Healthcare, Outlook, Process Improvement, Microsoft Excel, SAP, Access, Medicare, Pricing, Data Analysis, PowerPoint, Forecasting, Sales Operations, Analysis, Strategic Planning, Business Planning, Budgets, Teamwork, New Business Development, Sales Management, Team Building, Customer Service, SharePoint, Sales, Cross-functional Team..., Business Analysis, Negotiation, Microsoft Office, Project Planning, Inventory Management, Account Management, Time Management, Customer Satisfaction, Change Management, Coaching, Administration, Business Strategy, Business Development, Business Process...
Education
Kean University 1990 — 1995
BA, Physical Education/Adult Fitness
Jai Paul, MSME, MSAM's Cordis Corporation Experience October 2005 - March 2007
Job CSSBB, CQE, CMQ/OE
Industry Medical Devices
Experience
CR Bard - Davol Inc August 2013 - Present
Unilife Corporation June 2012 - July 2013
Boston Scientific March 2007 - May 2012
Cordis Corporation October 2005 - March 2007
Skills
ISO 13485, CAPA, V&V, Design of Experiments, Minitab, ISO 14971, 21 CFR Part 11, 21 CFR Part 820, DFMEA, PFMEA, Gage R&R, Medical Devices, Kaizen, 21 CFR, Validation, Design for Manufacturing, FDA, Failure Analysis, Quality System, Lean Manufacturing, FMEA, Design Control, DMAIC, Change Control, Test Methodologies, Root Cause Analysis, GMP, CQE, Sterilization, Continuous Improvement, SPC, Equipment Qualification, Six Sigma, Process Capability, Quality Management, Iso 9000, FDA GMP, Catheters, Supplier Quality, Sop, Black Belt, GD&T, Process Simulation, CE marking
Education
Indiana University-Purdue University at Indianapolis 2008 — 2012
Master of Science (M.S.), Applied Mathematics, 3.57 GPA
University of South Florida 2002 — 2005
Master of Science (M.S.), Mechanical Engineering, 3.54 GPA
Bangalore University 1996 — 2000
Bachelor of Engineering (B.E.), Mechanical Engineering, First Class with Distinction
CR Bard - Davol Inc August 2013 - Present
Unilife Corporation June 2012 - July 2013
Boston Scientific March 2007 - May 2012
Cordis Corporation October 2005 - March 2007
Skills
ISO 13485, CAPA, V&V, Design of Experiments, Minitab, ISO 14971, 21 CFR Part 11, 21 CFR Part 820, DFMEA, PFMEA, Gage R&R, Medical Devices, Kaizen, 21 CFR, Validation, Design for Manufacturing, FDA, Failure Analysis, Quality System, Lean Manufacturing, FMEA, Design Control, DMAIC, Change Control, Test Methodologies, Root Cause Analysis, GMP, CQE, Sterilization, Continuous Improvement, SPC, Equipment Qualification, Six Sigma, Process Capability, Quality Management, Iso 9000, FDA GMP, Catheters, Supplier Quality, Sop, Black Belt, GD&T, Process Simulation, CE marking
Education
Indiana University-Purdue University at Indianapolis 2008 — 2012
Master of Science (M.S.), Applied Mathematics, 3.57 GPA
University of South Florida 2002 — 2005
Master of Science (M.S.), Mechanical Engineering, 3.54 GPA
Bangalore University 1996 — 2000
Bachelor of Engineering (B.E.), Mechanical Engineering, First Class with Distinction
Yoni Arrieta's Cordis Corporation Experience September 2004 - July 2005
Job TOC, Lean Six Sigma, Industrial Engineering Specialist
Industry Aviation & Aerospace
Experience
Gulfstream Aerospace October 2011 - Present
Beckman Coulter May 2008 - December 2010
Boeing Commercial Airplanes July 2005 - May 2008
Cordis Corporation September 2004 - July 2005
General Electric-Wind Energy January 2004 - August 2004
ABC Distributing, LLC July 2003 - December 2003
Skills
Toyota Production System, Lean Manufacturing, Cellular Manufacturing, Theory of Constraints, Operations Management, Six Sigma, Value Stream Mapping, Manufacturing, Supply Chain Management, Kanban, Operational Excellence, Continuous Improvement
Education
Villanova University 2009 — 2009
Certificate, Six-Sigma Green BELT
Washington State University 2005 — 2008
Master, Engineering Management
Florida International University 2002 — 2005
Master, Industrial Engineering
Universidad Tecnológica de Bolívar 1996 — 2000
Bachelor, Industrial Engineering
Gulfstream Aerospace October 2011 - Present
Beckman Coulter May 2008 - December 2010
Boeing Commercial Airplanes July 2005 - May 2008
Cordis Corporation September 2004 - July 2005
General Electric-Wind Energy January 2004 - August 2004
ABC Distributing, LLC July 2003 - December 2003
Skills
Toyota Production System, Lean Manufacturing, Cellular Manufacturing, Theory of Constraints, Operations Management, Six Sigma, Value Stream Mapping, Manufacturing, Supply Chain Management, Kanban, Operational Excellence, Continuous Improvement
Education
Villanova University 2009 — 2009
Certificate, Six-Sigma Green BELT
Washington State University 2005 — 2008
Master, Engineering Management
Florida International University 2002 — 2005
Master, Industrial Engineering
Universidad Tecnológica de Bolívar 1996 — 2000
Bachelor, Industrial Engineering
Carl Horton's Cordis Corporation Experience June 1982 - June 1986
Job Co Founder, Cardiac Markers, LLC
Industry Medical Devices
Experience
Cardiac Markers June 2010 - Present
MedSource, LLC November 2005 - December 2010
Sorin Group January 1993 - May 2005
Guidant July 1986 - January 1992
Cordis Corporation June 1982 - June 1986
Intermedics, Inc. April 1979 - May 1983
Powers Medical, Inc. April 1979 - May 1982
Cordis Corporation June 1973 - April 1979
Skills
Start-ups, Sales, Management, Medical Devices, Market Development, Cardiology, Biomedical Engineering, Product Launch, Capital Equipment, FDA, Commercialization, Healthcare, Product Development, Operating Room, Sales Operations, Cross-functional Team..., Surgeons, New Business Development, Strategic Planning, Sales Management, Hospitals, Interventional...
Education
Anderson University
Indiana University-Purdue University at Indianapolis
Cardiac Markers June 2010 - Present
MedSource, LLC November 2005 - December 2010
Sorin Group January 1993 - May 2005
Guidant July 1986 - January 1992
Cordis Corporation June 1982 - June 1986
Intermedics, Inc. April 1979 - May 1983
Powers Medical, Inc. April 1979 - May 1982
Cordis Corporation June 1973 - April 1979
Skills
Start-ups, Sales, Management, Medical Devices, Market Development, Cardiology, Biomedical Engineering, Product Launch, Capital Equipment, FDA, Commercialization, Healthcare, Product Development, Operating Room, Sales Operations, Cross-functional Team..., Surgeons, New Business Development, Strategic Planning, Sales Management, Hospitals, Interventional...
Education
Anderson University
Indiana University-Purdue University at Indianapolis
ANN KLAUBER's Cordis Corporation Experience September 2005 - June 2006
Job HR PROFESSIONAL
Industry Human Resources
Experience
Aurobindo Pharma U.S.A. November 2013 - Present
Wholesale Energy July 2012 - October 2013
PRIVATE HEALTHCARE FIRM September 2010 - July 2011
VANGUARD MEDIA, LLC August 2006 - November 2010
CORDIS CORPORATION September 2005 - June 2006
NSG AMERICA, INC January 1999 - May 2004
Skills
Training, Recruiting, Onboarding, Employee Relations, Employee Benefits, Healthcare Management, Health and Welfare..., Performance Improvement, Performance Management, Employment Law, Personnel Management, Leadership, HRIS, Restructuring, 401k, Organization, Customer Service, Problem Solving, Troubleshooting, Disaster Recovery, Office Management, Microsoft Excel, Microsoft Word, Newsletters, Outsourcing, Sourcing, PowerPoint, Internet, Microsoft Office, ADP Payroll, ADP ReportSmith, Payroll, ADP E-Time, ADP ezLaborManager, Paychex, Ceridian, Auditing, Program Management, Policy, Management, Coaching, Human Resources, New Hire Orientations, Benefits Administration
Education
Villanova University
Professional certificate, STRATEGIC HR MGMT
Cornell University
HR Related Studies
Aurobindo Pharma U.S.A. November 2013 - Present
Wholesale Energy July 2012 - October 2013
PRIVATE HEALTHCARE FIRM September 2010 - July 2011
VANGUARD MEDIA, LLC August 2006 - November 2010
CORDIS CORPORATION September 2005 - June 2006
NSG AMERICA, INC January 1999 - May 2004
Skills
Training, Recruiting, Onboarding, Employee Relations, Employee Benefits, Healthcare Management, Health and Welfare..., Performance Improvement, Performance Management, Employment Law, Personnel Management, Leadership, HRIS, Restructuring, 401k, Organization, Customer Service, Problem Solving, Troubleshooting, Disaster Recovery, Office Management, Microsoft Excel, Microsoft Word, Newsletters, Outsourcing, Sourcing, PowerPoint, Internet, Microsoft Office, ADP Payroll, ADP ReportSmith, Payroll, ADP E-Time, ADP ezLaborManager, Paychex, Ceridian, Auditing, Program Management, Policy, Management, Coaching, Human Resources, New Hire Orientations, Benefits Administration
Education
Villanova University
Professional certificate, STRATEGIC HR MGMT
Cornell University
HR Related Studies
Jennifer Lopez's Cordis Corporation Experience 2002 - 2004
Job Sr. Regional Site Manager at Forest Laboratories
Industry Pharmaceuticals
Experience
FOREST RESEARCH INSTITUTE December 2008 - Present
FOREST RESEARCH INSTITUTE October 2005 - December 2008
FOREST RESEARCH INSTITUTE November 2004 - October 2005
CORDIS CORPORATION 2002 - 2004
STRYKER HOMEDICA OSTEONICS 2001 - 2002
WYETH PHARMACEUTICALS 1999 - 2001
WYETH PHARMACEUTICALS 1998 - 1999
Skills
CRO
Education
Montclair State University 1994 — 1997
Bachelor of Arts, Environmental, Urban & Geographic Studies
Davis and Elkins College 1992 — 1994
Environmental Science
FOREST RESEARCH INSTITUTE December 2008 - Present
FOREST RESEARCH INSTITUTE October 2005 - December 2008
FOREST RESEARCH INSTITUTE November 2004 - October 2005
CORDIS CORPORATION 2002 - 2004
STRYKER HOMEDICA OSTEONICS 2001 - 2002
WYETH PHARMACEUTICALS 1999 - 2001
WYETH PHARMACEUTICALS 1998 - 1999
Skills
CRO
Education
Montclair State University 1994 — 1997
Bachelor of Arts, Environmental, Urban & Geographic Studies
Davis and Elkins College 1992 — 1994
Environmental Science
Babu Periasamy's Cordis Corporation Experience April 2013 - Present
Job Experienced Regulatory Affairs Professional
Industry Medical Devices
Experience
Cordis Corporation April 2013 - Present
Independent Regulatory Consultant August 2012 - Present
Avinger Inc. October 2012 - March 2013
Abbott Vascular -Structural Heart March 2011 - July 2012
Cameron Health 2009 - 2011
Maquet Cardiovascular (formerly BSC/Guidant) 2007 - 2009
AMO May 2007 - August 2007
Skills
FDA, ISO 13485, Regulatory Affairs, CAPA, Design Control, Medical Devices, GMP, Quality System, Validation, 21 CFR Part 11, Biomedical Engineering, Clinical Trials, Regulatory Submissions, Change Control, Biotechnology, Clinical Development, Commercialization, R&D, Sop, V&V, ISO 14971, Regulatory Requirements, SOP
Education
Edinboro University of Pennsylvania
Bachelor of Science (B.S.), Biology, General
University of Southern California
M.S., MDDE
Cordis Corporation April 2013 - Present
Independent Regulatory Consultant August 2012 - Present
Avinger Inc. October 2012 - March 2013
Abbott Vascular -Structural Heart March 2011 - July 2012
Cameron Health 2009 - 2011
Maquet Cardiovascular (formerly BSC/Guidant) 2007 - 2009
AMO May 2007 - August 2007
Skills
FDA, ISO 13485, Regulatory Affairs, CAPA, Design Control, Medical Devices, GMP, Quality System, Validation, 21 CFR Part 11, Biomedical Engineering, Clinical Trials, Regulatory Submissions, Change Control, Biotechnology, Clinical Development, Commercialization, R&D, Sop, V&V, ISO 14971, Regulatory Requirements, SOP
Education
Edinboro University of Pennsylvania
Bachelor of Science (B.S.), Biology, General
University of Southern California
M.S., MDDE
Monica Grimaldi's Cordis Corporation Experience May 2004 - May 2009
Job Independent Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Johnson & Johnson Medical May 2007 - January 2010
Cordis Corporation May 2004 - May 2009
Ortho Clinical Diagnostics 1999 - 2004
Kalipharma / Purepac 1989 - 1992
Skills
GxP, Quality Systems, FDA, Change Control, Medical Devices, CAPA, Quality Auditing, cGMP, GMP, SOP, ISO, ISO 13485, Pharmaceuticals, Quality Assurance, Pharmaceutical Industry, Sop, Biotechnology, Quality System
Education
Stony Brook University 1965 — 1969
BS, Chemistry
Johnson & Johnson Medical May 2007 - January 2010
Cordis Corporation May 2004 - May 2009
Ortho Clinical Diagnostics 1999 - 2004
Kalipharma / Purepac 1989 - 1992
Skills
GxP, Quality Systems, FDA, Change Control, Medical Devices, CAPA, Quality Auditing, cGMP, GMP, SOP, ISO, ISO 13485, Pharmaceuticals, Quality Assurance, Pharmaceutical Industry, Sop, Biotechnology, Quality System
Education
Stony Brook University 1965 — 1969
BS, Chemistry
Kim Pottinger's Cordis Corporation Experience 1982 - 1984
Job Teacher, Civics at Millennium Middle School
Industry Education Management
Experience
Millennium Middle School January 2012 - Present
Seminole County Public Schools - Lake Mary High School August 2010 - June 2011
Komatsu America Corporation 1986 - 1989
Tensar Corporation 1984 - 1986
Cordis Corporation 1982 - 1984
Education
Auburn University
Millennium Middle School January 2012 - Present
Seminole County Public Schools - Lake Mary High School August 2010 - June 2011
Komatsu America Corporation 1986 - 1989
Tensar Corporation 1984 - 1986
Cordis Corporation 1982 - 1984
Education
Auburn University
Rosemary Serbent Harry's Cordis Corporation Experience 1984 - 1993
Job Device Foundations
Industry Medical Devices
Experience
Device Foundations, Inc 2011 - Present
ORTHOCON 2011 - 2012
RHarry Consulting 2000 - June 2011
Zeltiq Aesthetics 2005 - 2010
Calypso Medical 2000 - 2007
Frazier Healthcare Ventures 2000 - 2007
EKOS Corporation 1998 - 2000
Quinton Instrument Company 1995 - 1998
Cordis Corporation 1984 - 1993
Skills
Medical Devices, FDA, Design Control, ISO 13485, Regulatory Affairs, Clinical Research, Cardiology, Quality System, Clinical Trials, V&V, Commercialization, Regulatory Submissions, Capital Equipment, Clinical Development, Biotechnology, Validation, Biomedical Engineering, CAPA
Education
Saint Mary's College 1975 — 1979
BS, Biology
University of Miami
MSBME, Biomedical Engineering
Device Foundations, Inc 2011 - Present
ORTHOCON 2011 - 2012
RHarry Consulting 2000 - June 2011
Zeltiq Aesthetics 2005 - 2010
Calypso Medical 2000 - 2007
Frazier Healthcare Ventures 2000 - 2007
EKOS Corporation 1998 - 2000
Quinton Instrument Company 1995 - 1998
Cordis Corporation 1984 - 1993
Skills
Medical Devices, FDA, Design Control, ISO 13485, Regulatory Affairs, Clinical Research, Cardiology, Quality System, Clinical Trials, V&V, Commercialization, Regulatory Submissions, Capital Equipment, Clinical Development, Biotechnology, Validation, Biomedical Engineering, CAPA
Education
Saint Mary's College 1975 — 1979
BS, Biology
University of Miami
MSBME, Biomedical Engineering
Wesley Van De Water's Cordis Corporation Experience February 1982 - June 1985
Job Sales and Technical Consultant CRM at Sorin Group
Industry Marketing and Advertising
Experience
Sorin Group November 2012 - Present
Fresh Impression September 2008 - Present
Lockwoods Greenhouses and Farm April 2007 - September 2008
Guidant January 2006 - February 2007
Guidant August 2000 - January 2006
Guidant August 1995 - August 2000
Telectronics Pacing Systems July 1985 - August 1995
Cordis Corporation February 1982 - June 1985
Cordis Corporation February 1981 - February 1982
Cordis Corporation June 1980 - February 1981
Education
Hobart and William Smith Colleges 1974 — 1978
BS, Biology
Sorin Group November 2012 - Present
Fresh Impression September 2008 - Present
Lockwoods Greenhouses and Farm April 2007 - September 2008
Guidant January 2006 - February 2007
Guidant August 2000 - January 2006
Guidant August 1995 - August 2000
Telectronics Pacing Systems July 1985 - August 1995
Cordis Corporation February 1982 - June 1985
Cordis Corporation February 1981 - February 1982
Cordis Corporation June 1980 - February 1981
Education
Hobart and William Smith Colleges 1974 — 1978
BS, Biology
Angela Falzone's Cordis Corporation Experience August 2003 - June 2013
Job Director of Validation, Fort Washington Site
Industry Pharmaceuticals
Experience
McNeil Consumer Healthcare January 2014 - Present
McNeil Consumer Healthcare January 2014 - Present
Cordis Corporation August 2003 - June 2013
Education
University of the Sciences in Philadelphia 1979 — 1984
Bachelor of Science, Pharmacy
Purdue University
McNeil Consumer Healthcare January 2014 - Present
McNeil Consumer Healthcare January 2014 - Present
Cordis Corporation August 2003 - June 2013
Education
University of the Sciences in Philadelphia 1979 — 1984
Bachelor of Science, Pharmacy
Purdue University
Patrick Rimroth's Cordis Corporation Experience June 1979 - April 1986
Job General Manager at Mizuho OSI
Industry Medical Devices
Experience
Mizuho OSI February 2008 - Present
PneumRx, Inc. May 2006 - January 2008
Access Closure, Inc. February 2006 - May 2006
Curon Medical September 2001 - January 2006
Symphonix Devices, Inc. November 1995 - August 2001
Camino NeuroCare, Inc. June 1994 - November 1995
CR Bard, Electrophysiology Division September 1992 - June 1994
Bard Critical Care December 1988 - September 1992
Telectronics and Cordis Pacing Systems May 1986 - December 1988
Cordis Corporation June 1979 - April 1986
Skills
Medical Devices, FDA, ISO 13485, Design Control, Capital Equipment, Quality System, Design for Manufacturing, R&D, Product Development, Manufacturing, Catheters, SAP ERP, Electrical Engineering, Operations Management, Implants, Sterilization, Quality Management, Disposables, ETO, Operating Room, Cross-functional Team..., Product Launch, CAPA, V&V, Pacemaker Design and..., Cardiac Mapping, Implantable Hearing..., Multi-Site Management, Steerable Catheter..., RF Engineering and..., Biomedical Engineering, Validation, Market Development, Commercialization, GMP, Process Improvement
Education
Purdue University 1973 — 1979
BSEE, Electrical and Electronics Engineering
Purdue University 1973 — 1979
Bachelor of Science (BS), Biology, General, Anatomy, Physiology
Mizuho OSI February 2008 - Present
PneumRx, Inc. May 2006 - January 2008
Access Closure, Inc. February 2006 - May 2006
Curon Medical September 2001 - January 2006
Symphonix Devices, Inc. November 1995 - August 2001
Camino NeuroCare, Inc. June 1994 - November 1995
CR Bard, Electrophysiology Division September 1992 - June 1994
Bard Critical Care December 1988 - September 1992
Telectronics and Cordis Pacing Systems May 1986 - December 1988
Cordis Corporation June 1979 - April 1986
Skills
Medical Devices, FDA, ISO 13485, Design Control, Capital Equipment, Quality System, Design for Manufacturing, R&D, Product Development, Manufacturing, Catheters, SAP ERP, Electrical Engineering, Operations Management, Implants, Sterilization, Quality Management, Disposables, ETO, Operating Room, Cross-functional Team..., Product Launch, CAPA, V&V, Pacemaker Design and..., Cardiac Mapping, Implantable Hearing..., Multi-Site Management, Steerable Catheter..., RF Engineering and..., Biomedical Engineering, Validation, Market Development, Commercialization, GMP, Process Improvement
Education
Purdue University 1973 — 1979
BSEE, Electrical and Electronics Engineering
Purdue University 1973 — 1979
Bachelor of Science (BS), Biology, General, Anatomy, Physiology
Eugene Melewski, PE, PMP's Cordis Corporation Experience 2009 - 2012
Job Project Management Consultant at Acclarent
Industry Medical Devices
Experience
Acclarent 2015 - Present
Thermo Fisher Scientific 2013 - 2015
Centofanti Consulting Inc. 2012 - 2013
Cordis Corporation 2009 - 2012
LifeScan 2006 - 2009
Johnson & Johnson 1998 - 2005
Skills
Six Sigma, Lean Manufacturing, Design Control, Design for Manufacturing, Medical Devices, ISO 13485, ISO 14971, Cross-functional Team..., R&D, Manufacturing, Process Improvement, Root Cause Analysis, Project Management, Validation, V&V, Process Engineering, IEC 60601, FMEA, DMAIC, Process Excellence, International Project..., Multi-cultural Team..., Process Development, Management Of..., Intercultural Awareness, GMP, Technology Transfer, Continuous Improvement, Change Control, MS Project, Program Management, Computer System..., Automation, GxP, SDLC, Vendor Management, Project Planning, Process Simulation, PMO, Quality System, Design of Experiments, SPC, Quality Assurance, Supply Chain, Minitab, Engineering Management, Engineering, 21 CFR Part 11, FDA
Education
Stevens Institute of Technology
Bachelor of Engineering (BE), Electrical Engineering
Acclarent 2015 - Present
Thermo Fisher Scientific 2013 - 2015
Centofanti Consulting Inc. 2012 - 2013
Cordis Corporation 2009 - 2012
LifeScan 2006 - 2009
Johnson & Johnson 1998 - 2005
Skills
Six Sigma, Lean Manufacturing, Design Control, Design for Manufacturing, Medical Devices, ISO 13485, ISO 14971, Cross-functional Team..., R&D, Manufacturing, Process Improvement, Root Cause Analysis, Project Management, Validation, V&V, Process Engineering, IEC 60601, FMEA, DMAIC, Process Excellence, International Project..., Multi-cultural Team..., Process Development, Management Of..., Intercultural Awareness, GMP, Technology Transfer, Continuous Improvement, Change Control, MS Project, Program Management, Computer System..., Automation, GxP, SDLC, Vendor Management, Project Planning, Process Simulation, PMO, Quality System, Design of Experiments, SPC, Quality Assurance, Supply Chain, Minitab, Engineering Management, Engineering, 21 CFR Part 11, FDA
Education
Stevens Institute of Technology
Bachelor of Engineering (BE), Electrical Engineering
Luis M. Toledo's Cordis Corporation Experience January 1994 - January 2004
Job Sr.Mechanical/Manufacturing/ProcessTechnician at Boston Scientific
Industry Medical Devices
Experience
Boston Scientific January 2004 - Present
Boston Scientific September 2004 - December 2011
Boston Scientific January 2004 - December 2011
Cordis Corporation January 1994 - January 2004
Cordis Corporation January 1994 - January 2004
Cordis Corp 1994 - 2004
Cordis Corp 1994 - 2004
AT&T January 1985 - January 1994
AT&T January 1985 - January 1994
Skills
Validation, ISO, Manufacturing, Calibration, Engineering, Solidworks, Root Cause Analysis, Six Sigma, Troubleshooting, CAPA, Design Control, V&V, Software Documentation, Medical Devices, Kaizen, Electronics, FDA, Design of Experiments, FMEA, ISO 13485, R&D, Quality System, Testing
Education
DeVry University 2010 — 2011
Bachelor Technical management
DeVry University 2010 — 2011
B.S, Technical Management; Project Management
DeVry University
B.S, Technical Management; Project Management
Boston Scientific January 2004 - Present
Boston Scientific September 2004 - December 2011
Boston Scientific January 2004 - December 2011
Cordis Corporation January 1994 - January 2004
Cordis Corporation January 1994 - January 2004
Cordis Corp 1994 - 2004
Cordis Corp 1994 - 2004
AT&T January 1985 - January 1994
AT&T January 1985 - January 1994
Skills
Validation, ISO, Manufacturing, Calibration, Engineering, Solidworks, Root Cause Analysis, Six Sigma, Troubleshooting, CAPA, Design Control, V&V, Software Documentation, Medical Devices, Kaizen, Electronics, FDA, Design of Experiments, FMEA, ISO 13485, R&D, Quality System, Testing
Education
DeVry University 2010 — 2011
Bachelor Technical management
DeVry University 2010 — 2011
B.S, Technical Management; Project Management
DeVry University
B.S, Technical Management; Project Management
Judianne Davis-Van Nostrand's Cordis Corporation Experience June 1989 - September 1989
Job
Industry Research
Experience
Stony Brook University September 1996 - Present
University of North Carolina at Chapel Hill June 1995 - September 1996
UC Irvine September 1989 - June 1995
Cordis Corporation June 1989 - September 1989
National Eye Institute, NIH May 1988 - June 1989
Bascom Palmer Eye Institute, University of Miami 1985 - 1989
Maimi Meterozoo 1984 - 1985
Denver Zoo 1983 - 1984
Los Angeles Zoo 1982 - 1983
Playboy Mansion Zoo 1982 - 1983
Skills
Neurodegenerative..., Opthalmic Research, Higher Education..., Teaching, Life Sciences, Research, Molecular Biology, Tissue Culture, PCR, ELISA, Genetics, Data Analysis, Cell Based Assays, Cell Culture, Microsoft Office, Purification, Word, Analysis, Experimentation, R, Animal Models, Writing, PowerPoint, Administration, Editing, Excel, Cancer, Photoshop, Windows, RT-PCR, Western Blotting, Microscopy, Biochemistry, DNA, Gel Electrophoresis, RNA isolation, qPCR, Science, Cell Biology, Immunohistochemistry, Transfection, DNA extraction, Immunoprecipitation, SDS-PAGE, Fluorescence Microscopy, Immunofluorescence, Cell, Molecular Cloning, Scientific Writing, Microbiology
Education
Stony Brook University 2004 — 2006
MA, Education
California State University-Long Beach 1993 — 1995
MS, Biology
University of California, Irvine 1989 — 1993
BS, Biology
Moorpark College 1981 — 1983
A.S., Zoology
Stony Brook University September 1996 - Present
University of North Carolina at Chapel Hill June 1995 - September 1996
UC Irvine September 1989 - June 1995
Cordis Corporation June 1989 - September 1989
National Eye Institute, NIH May 1988 - June 1989
Bascom Palmer Eye Institute, University of Miami 1985 - 1989
Maimi Meterozoo 1984 - 1985
Denver Zoo 1983 - 1984
Los Angeles Zoo 1982 - 1983
Playboy Mansion Zoo 1982 - 1983
Skills
Neurodegenerative..., Opthalmic Research, Higher Education..., Teaching, Life Sciences, Research, Molecular Biology, Tissue Culture, PCR, ELISA, Genetics, Data Analysis, Cell Based Assays, Cell Culture, Microsoft Office, Purification, Word, Analysis, Experimentation, R, Animal Models, Writing, PowerPoint, Administration, Editing, Excel, Cancer, Photoshop, Windows, RT-PCR, Western Blotting, Microscopy, Biochemistry, DNA, Gel Electrophoresis, RNA isolation, qPCR, Science, Cell Biology, Immunohistochemistry, Transfection, DNA extraction, Immunoprecipitation, SDS-PAGE, Fluorescence Microscopy, Immunofluorescence, Cell, Molecular Cloning, Scientific Writing, Microbiology
Education
Stony Brook University 2004 — 2006
MA, Education
California State University-Long Beach 1993 — 1995
MS, Biology
University of California, Irvine 1989 — 1993
BS, Biology
Moorpark College 1981 — 1983
A.S., Zoology
Ann Karakla's Cordis Corporation Experience 1993 - July 2003
Job Retired
Industry Medical Devices
Experience
Cordis Corporation 1993 - July 2003
Education
American International College
Bachelor of Science (B.S.), Business/Minor in Education
Bay Path Junior College
Associate's Degree, Business
Cordis Corporation 1993 - July 2003
Education
American International College
Bachelor of Science (B.S.), Business/Minor in Education
Bay Path Junior College
Associate's Degree, Business
Franzine Shields's Cordis Corporation Experience May 2005 - Present
Job BI System Manager at Cordis Corporation
Industry Medical Devices
Experience
Cordis Corporation May 2005 - Present
Cordis February 2000 - Present
Skills
Medical Devices, FDA, ISO 13485, Validation, Quality System, CAPA, Design Control, Six Sigma, Cross-functional Team..., R&D, V&V, Quality Assurance, GMP, Process Improvement, Product Launch, Capital Equipment, Product Development, Design of Experiments, Market Development, Biomedical Engineering
Education
Loyola University New Orleans 1976 — 1977
N/A, Computer Science
University of Miami 1969 — 1971
N/A, Accounting
Cordis Corporation May 2005 - Present
Cordis February 2000 - Present
Skills
Medical Devices, FDA, ISO 13485, Validation, Quality System, CAPA, Design Control, Six Sigma, Cross-functional Team..., R&D, V&V, Quality Assurance, GMP, Process Improvement, Product Launch, Capital Equipment, Product Development, Design of Experiments, Market Development, Biomedical Engineering
Education
Loyola University New Orleans 1976 — 1977
N/A, Computer Science
University of Miami 1969 — 1971
N/A, Accounting
Fred R. Connell's Cordis Corporation Experience July 2012 - Present
Job Graphic Designer for Labeling CoE at Cordis a Johnson and Johnson company
Industry Medical Devices
Experience
Cordis Corporation July 2012 - Present
Education
Broward College 2014 — 2016
Bachelor’s Degree
Broward College 2006 — 2008
Associate of Arts and Sciences (A.A.S.)
Broward College
Associate’s Degree
Cordis Corporation July 2012 - Present
Education
Broward College 2014 — 2016
Bachelor’s Degree
Broward College 2006 — 2008
Associate of Arts and Sciences (A.A.S.)
Broward College
Associate’s Degree
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY