CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY
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CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Employees
Employee
Years
Job
Industry
Sharon Labbate Sharon Labbate's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 2006 - 2009
Job Franchise Director | Change Strategy | North America Region | Janssen Pharmaceuticals Inc., Pharmaceutical Companies of
Industry Hospital & Health Care
Experience
Janssen Pharmaceuticals Inc., Pharmaceutical Companies of Johnson & Johnson 2015 - Present
Janssen Pharmaceuticals Inc., Pharmaceutical Companies of Johnson & Johnson 2009 - 2015
Cordis Corporation, a Johnson and Johnson Company 2006 - 2009
Cordis Corporation and Biosense Webster, Inc. 2003 - 2006
PeopleSoft Usa Inc 1999 - 2003
Booz & Company 1995 - 1999
Skills
Succession Planning, Talent Management, Talent Acquisition, Onboarding, Performance Management, Organizational..., HR Policies, Workforce Planning, Organizational Design, Human Resources, Pharmaceutical Industry, HRIS, Organizational..., Personnel Management, Employee Relations, Coaching, Executive Coaching, Leadership Development, Deferred Compensation, Employee Engagement, Labor Relations, HR Transformation, Culture Change, Performance Improvement, HR Consulting, Benefits Administration, Employee Benefits, Compensation & Benefit, Recruiting
Education
Baruch College, City University of New York (CUNY)
MBA Master of Business Administration, Industrial and Organizational Psychology
Hofstra University
BA Bachelor of Arts, Psychology, Industrial and Organizational Psychology
Janssen Pharmaceuticals Inc., Pharmaceutical Companies of Johnson & Johnson 2015 - Present
Janssen Pharmaceuticals Inc., Pharmaceutical Companies of Johnson & Johnson 2009 - 2015
Cordis Corporation, a Johnson and Johnson Company 2006 - 2009
Cordis Corporation and Biosense Webster, Inc. 2003 - 2006
PeopleSoft Usa Inc 1999 - 2003
Booz & Company 1995 - 1999
Skills
Succession Planning, Talent Management, Talent Acquisition, Onboarding, Performance Management, Organizational..., HR Policies, Workforce Planning, Organizational Design, Human Resources, Pharmaceutical Industry, HRIS, Organizational..., Personnel Management, Employee Relations, Coaching, Executive Coaching, Leadership Development, Deferred Compensation, Employee Engagement, Labor Relations, HR Transformation, Culture Change, Performance Improvement, HR Consulting, Benefits Administration, Employee Benefits, Compensation & Benefit, Recruiting
Education
Baruch College, City University of New York (CUNY)
MBA Master of Business Administration, Industrial and Organizational Psychology
Hofstra University
BA Bachelor of Arts, Psychology, Industrial and Organizational Psychology
Heather Harries Heather Harries's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience May 2005 - December 2007
Job Vice President of Quality Assurance at Bolton Medical
Industry Medical Devices
Experience
Bolton Medical April 2015 - Present
Heather Harries Medical Device Consulting, Inc. November 2009 - Present
Johnson & Johnson November 2012 - April 2015
Cordis July 2010 - November 2012
HeartWare Inc January 2008 - September 2009
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY May 2005 - December 2007
Cordis March 2003 - May 2005
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY December 2000 - March 2003
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY July 1998 - December 2000
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY July 1997 - July 1998
Skills
Healthcare, R&D, Medical Devices, Quality Assurance, Program Management, Product Development, Quality Engineering, Quality Auditing, ISO standards, Risk Management, Change Management, Change Control, FDA, Engineering, Problem Solving, Testing, Technical Writing, Design Control, ISO 13485, Cross-functional Team..., Quality Management, Product Launch, Project Planning, Biotechnology, Quality System, FMEA, Manufacturing, Design of Experiments, Root Cause Analysis, ISO, Validation, Quality Control, CAPA, V&V, Team Leadership, Regulatory Affairs, Process Engineering, GMP, Sop, Software Documentation, Minitab, DMAIC, ISO 14971, Process Simulation, 21 CFR Part 11, Biomedical Engineering, SPC, Commercialization, Technology Transfer, Leadership
Education
Florida International University 1999 — 2001
M.S., Engineering Management
Dartmouth College 1995 — 1997
M.S., Biomaterials Engineering
Duke University 1991 — 1995
BS, Biomedical and Mechanical Engineering and Materials Science
Ellenville Central 1979 — 1991
High School Degree, General
Bolton Medical April 2015 - Present
Heather Harries Medical Device Consulting, Inc. November 2009 - Present
Johnson & Johnson November 2012 - April 2015
Cordis July 2010 - November 2012
HeartWare Inc January 2008 - September 2009
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY May 2005 - December 2007
Cordis March 2003 - May 2005
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY December 2000 - March 2003
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY July 1998 - December 2000
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY July 1997 - July 1998
Skills
Healthcare, R&D, Medical Devices, Quality Assurance, Program Management, Product Development, Quality Engineering, Quality Auditing, ISO standards, Risk Management, Change Management, Change Control, FDA, Engineering, Problem Solving, Testing, Technical Writing, Design Control, ISO 13485, Cross-functional Team..., Quality Management, Product Launch, Project Planning, Biotechnology, Quality System, FMEA, Manufacturing, Design of Experiments, Root Cause Analysis, ISO, Validation, Quality Control, CAPA, V&V, Team Leadership, Regulatory Affairs, Process Engineering, GMP, Sop, Software Documentation, Minitab, DMAIC, ISO 14971, Process Simulation, 21 CFR Part 11, Biomedical Engineering, SPC, Commercialization, Technology Transfer, Leadership
Education
Florida International University 1999 — 2001
M.S., Engineering Management
Dartmouth College 1995 — 1997
M.S., Biomaterials Engineering
Duke University 1991 — 1995
BS, Biomedical and Mechanical Engineering and Materials Science
Ellenville Central 1979 — 1991
High School Degree, General
Mira (Sullivan) Leiwant's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience September 2007 - December 2007
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
Rients Van Werven Rients Van Werven's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 2007 - October 2012
Job Execution Excellence Manager Packaging and Product labeling at Ethicon EndoSurgery
Industry Medical Devices
Experience
Ethicon Endo-Surgery February 2013 - Present
Johnson & Johnson October 2009 - Present
Cordis Corporation a Johnson and Johnson Company 2007 - October 2012
Cordis / Johnson & Johnson November 2006 - August 2007
Johnson & Johnson October 2005 - November 2006
cordis europa 1991 - 2006
Cordis Europa N.V. October 2003 - October 2005
Cordis Europa January 2002 - October 2003
Cordis Europa N.V. March 2000 - February 2002
Cordis Europa N.V. January 1997 - March 2000
Skills
Liaison, Medical Devices, CAPA, ISO 13485, Quality System, Change Control, Manufacturing, Technology Transfer, FDA, Six Sigma, Design Control, Regulatory Affairs, Change Management, Commercialization, V&V, Validation, Design of Experiments, Software Documentation, DMAIC, R&D, Quality Assurance, GMP, FMEA, 21 CFR Part 11, Quality Management, Continuous Improvement, ISO 14971, Process Simulation, Management, Biomedical Engineering, Root Cause Analysis, ISO, SPC, Cross-functional Team..., Lean Manufacturing, Minitab, Design for Manufacturing, Computer System..., Engineering, Injection Molding, Manufacturing..., Process Engineering, Product Launch, Quality Auditing, Quality Control, Sop, Supplier Quality, Supply Chain Management, Black Belt, GxP
Education
1992 — 1998
Ethicon Endo-Surgery February 2013 - Present
Johnson & Johnson October 2009 - Present
Cordis Corporation a Johnson and Johnson Company 2007 - October 2012
Cordis / Johnson & Johnson November 2006 - August 2007
Johnson & Johnson October 2005 - November 2006
cordis europa 1991 - 2006
Cordis Europa N.V. October 2003 - October 2005
Cordis Europa January 2002 - October 2003
Cordis Europa N.V. March 2000 - February 2002
Cordis Europa N.V. January 1997 - March 2000
Skills
Liaison, Medical Devices, CAPA, ISO 13485, Quality System, Change Control, Manufacturing, Technology Transfer, FDA, Six Sigma, Design Control, Regulatory Affairs, Change Management, Commercialization, V&V, Validation, Design of Experiments, Software Documentation, DMAIC, R&D, Quality Assurance, GMP, FMEA, 21 CFR Part 11, Quality Management, Continuous Improvement, ISO 14971, Process Simulation, Management, Biomedical Engineering, Root Cause Analysis, ISO, SPC, Cross-functional Team..., Lean Manufacturing, Minitab, Design for Manufacturing, Computer System..., Engineering, Injection Molding, Manufacturing..., Process Engineering, Product Launch, Quality Auditing, Quality Control, Sop, Supplier Quality, Supply Chain Management, Black Belt, GxP
Education
1992 — 1998
Haya Taitel's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 2011 - Present
Job VP of New Products Commercialization at Kadmon Pharmaceuticals, LLC
Industry Pharmaceuticals
Experience
Kadmon Pharmaceuticals, LLC February 2014 - Present
Cordis Corporation a Johnson and Johnson Company 2011 - Present
Cordis Corporation a Johnson and Johnson Company 2010 - 2011
Ortho-McNeil Pharmaceutical Division of Johnson and Johnson 2005 - 2010
Ortho-McNeil Pharmaceutical Division of Johnson and Johnson 2004 - 2005
Ortho-McNeil Pharmaceutical Division of Johnson and Johnson 2002 - 2004
Ortho-McNeil Pharmaceutical Division of Johnson and Johnson 2000 - 2002
Ortho-McNeil Pharmaceutical Division of Johnson and Johnson 1997 - 2000
Ortho-McNeil Pharmaceutical Division of Johnson and Johnson 1993 - 1996
Promedex, Inc. acquired by Johnson and Johnson 1992 - 1993
Education
Temple University School of Medicine
MS Master's in Pharmacology, Pharmacology Embryotoxicity Immunology
The Hebrew University
BS Bachelor of Science, Pharmacy & Biology
Kadmon Pharmaceuticals, LLC February 2014 - Present
Cordis Corporation a Johnson and Johnson Company 2011 - Present
Cordis Corporation a Johnson and Johnson Company 2010 - 2011
Ortho-McNeil Pharmaceutical Division of Johnson and Johnson 2005 - 2010
Ortho-McNeil Pharmaceutical Division of Johnson and Johnson 2004 - 2005
Ortho-McNeil Pharmaceutical Division of Johnson and Johnson 2002 - 2004
Ortho-McNeil Pharmaceutical Division of Johnson and Johnson 2000 - 2002
Ortho-McNeil Pharmaceutical Division of Johnson and Johnson 1997 - 2000
Ortho-McNeil Pharmaceutical Division of Johnson and Johnson 1993 - 1996
Promedex, Inc. acquired by Johnson and Johnson 1992 - 1993
Education
Temple University School of Medicine
MS Master's in Pharmacology, Pharmacology Embryotoxicity Immunology
The Hebrew University
BS Bachelor of Science, Pharmacy & Biology
Tony Manguno Tony Manguno's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience June 2003 - March 2007
Job Senior R&D Engineer at Bolton Medical
Industry Medical Devices
Experience
Bolton Medical January 2012 - Present
Bolton Medical, Inc. April 2007 - February 2012
Cordis June 2003 - March 2007
Cordis Corporation a Johnson and Johnson Company June 2003 - March 2007
GlaxoSmithKline January 2003 - June 2003
Skills
Design Control, Medical Devices, Solidworks, CAPA, Design of Experiments, FMEA, Stents, Product Development, R&D, Delivery Systems, Engineering Management, Biomedical Engineering, CAD, Medical Device Product..., Engineering, Validation, FDA, Cross-functional Team..., ISO 13485, Catheters, Commercialization, V&V, Root Cause Analysis, Injection Molding, Quality System, ISO 14971, Drug Delivery
Education
Florida International University 2005 — 2006
Master of Science, Engineering Management with Concentration in Biomedical Engineering
Florida International University 1999 — 2002
BS, Mechanical/Biomedical Engineering
Bolton Medical January 2012 - Present
Bolton Medical, Inc. April 2007 - February 2012
Cordis June 2003 - March 2007
Cordis Corporation a Johnson and Johnson Company June 2003 - March 2007
GlaxoSmithKline January 2003 - June 2003
Skills
Design Control, Medical Devices, Solidworks, CAPA, Design of Experiments, FMEA, Stents, Product Development, R&D, Delivery Systems, Engineering Management, Biomedical Engineering, CAD, Medical Device Product..., Engineering, Validation, FDA, Cross-functional Team..., ISO 13485, Catheters, Commercialization, V&V, Root Cause Analysis, Injection Molding, Quality System, ISO 14971, Drug Delivery
Education
Florida International University 2005 — 2006
Master of Science, Engineering Management with Concentration in Biomedical Engineering
Florida International University 1999 — 2002
BS, Mechanical/Biomedical Engineering
Eamonn P. FitzGerald MSEM Eamonn P. FitzGerald MSEM's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience March 1996 - June 2003
Job Experienced Director of Programs with technical accomplishments in the medical device industry.
Industry Medical Devices
Experience
Stryker MAKO April 2012 - Present
MD3 1996 - 2013
Cordis April 2009 - March 2012
Cordis August 2008 - April 2009
Cordis Cardiology, Operations, a Division of Cordis Corporation a Johnson and Johnson company, Miami August 2006 - April 2008
Cordis Endovascular, a Division of Cordis Corporation a Johnson and Johnson company May 2005 - August 2006
- Cordis Corporation a Johnson and Johnson Company, Miami Lakes, Florida June 2003 - May 2005
Cordis Corporation a Johnson and Johnson Company March 1996 - June 2003
Skills
Validation, Lean Manufacturing, Six Sigma, Cross-functional Team..., Molding, Extrusion, Continuous Improvement, R&D, Medical Devices, V&V, FDA, ISO 13485, GMP, ISO, Electro-mechanical, Engineering, Design Control, Process Improvement, Design for Manufacturing, Leadership, Process Simulation, Manufacturing, Polymers, Product Development, Quality Assurance, Testing, Quality System, SPC, FMEA, Root Cause Analysis, Manufacturing..., Product Management
Education
Florida International University
Masters, Engineering
Barry University
Bachelor, Admin
Internal Training
Process Excellence - Green Belt Certification
City and Guilds
Apprentice Tool Maker
Stryker MAKO April 2012 - Present
MD3 1996 - 2013
Cordis April 2009 - March 2012
Cordis August 2008 - April 2009
Cordis Cardiology, Operations, a Division of Cordis Corporation a Johnson and Johnson company, Miami August 2006 - April 2008
Cordis Endovascular, a Division of Cordis Corporation a Johnson and Johnson company May 2005 - August 2006
- Cordis Corporation a Johnson and Johnson Company, Miami Lakes, Florida June 2003 - May 2005
Cordis Corporation a Johnson and Johnson Company March 1996 - June 2003
Skills
Validation, Lean Manufacturing, Six Sigma, Cross-functional Team..., Molding, Extrusion, Continuous Improvement, R&D, Medical Devices, V&V, FDA, ISO 13485, GMP, ISO, Electro-mechanical, Engineering, Design Control, Process Improvement, Design for Manufacturing, Leadership, Process Simulation, Manufacturing, Polymers, Product Development, Quality Assurance, Testing, Quality System, SPC, FMEA, Root Cause Analysis, Manufacturing..., Product Management
Education
Florida International University
Masters, Engineering
Barry University
Bachelor, Admin
Internal Training
Process Excellence - Green Belt Certification
City and Guilds
Apprentice Tool Maker
Dennis Genito Dennis Genito's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 1999 - 2004
Job Vice President, Regulatory Affairs at MAQUET Cardiovascular
Industry Medical Devices
Experience
MAQUET Cardiovascular June 2009 - Present
Prescient Medical, Inc. August 2004 - June 2009
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY 1999 - 2004
Cordis a Johnson & Johnson Co. 1997 - 2004
Cordis Endovascular 1997 - 1999
Meadox Medicals 1985 - 1997
Pharmacia Opthalmics March 1983 - April 1985
Skills
Medical Devices, FDA, PMA, Regulations, Quality System, Vascular, Regulatory Affairs, Clinical Research, Clinical Development, CAPA, R&D, CE marking, Commercialization, V&V, Design Control, Stents, Sop, Product Launch, Quality Assurance, 21 CFR Part 11, ISO 13485, Validation, Biotechnology, Change Control, Cross-functional Team..., GMP, ISO 14971, Lifesciences, Regulatory Submissions, Clinical Trials, Biomedical Engineering, Medical Device Directive, 21 CFR
Education
University of New Haven 1972 — 1976
BS, Biology
MAQUET Cardiovascular June 2009 - Present
Prescient Medical, Inc. August 2004 - June 2009
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY 1999 - 2004
Cordis a Johnson & Johnson Co. 1997 - 2004
Cordis Endovascular 1997 - 1999
Meadox Medicals 1985 - 1997
Pharmacia Opthalmics March 1983 - April 1985
Skills
Medical Devices, FDA, PMA, Regulations, Quality System, Vascular, Regulatory Affairs, Clinical Research, Clinical Development, CAPA, R&D, CE marking, Commercialization, V&V, Design Control, Stents, Sop, Product Launch, Quality Assurance, 21 CFR Part 11, ISO 13485, Validation, Biotechnology, Change Control, Cross-functional Team..., GMP, ISO 14971, Lifesciences, Regulatory Submissions, Clinical Trials, Biomedical Engineering, Medical Device Directive, 21 CFR
Education
University of New Haven 1972 — 1976
BS, Biology
Mayda Matos's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience August 2006 - July 2008
Job QS Manager at AMO
Industry Medical Devices
Experience
Abbott Medical Optics September 2014 - Present
Medtronic November 2012 - October 2014
Pall Life Sciences November 2010 - November 2012
Pall Life Sciences 2010 - September 2012
Angiotech July 2008 - December 2010
Cordis LLC August 2006 - July 2008
Cordis, Johnson & Johnson August 2006 - July 2008
Cordis Corporation a Johnson and Johnson company August 2006 - July 2008
Cordis 2003 - 2008
Cordis, a Johnson and Johnson Company 2003 - 2006
Skills
CAPA, ISO 13485, FDA, Quality System, V&V, Regulatory Affairs, Sterilization, Medical Devices, Laboratory, Quality Management, Supplier Quality, ISO 14971, Quality Assurance, GxP, Design Control, Root Cause Analysis, Change Control, ISO, DMAIC, Sop, GMP, GLP, Computer System..., Validation, FMEA, Quality Control, Minitab, Quality Auditing, Design of Experiments, 21 CFR Part 11, Iso 9000, Six Sigma, Technology Transfer, GAMP, Process Simulation, CQE, FDA GMP, Medical Device Directive, LIMS, CE marking, Biopharmaceuticals, CQA, Trackwise, Aseptic Processing, 21 CFR, SPC, Regulatory Requirements, Biocompatibility, Calibration, PMA
Education
Inter American University School of Medical Technology 1981 — 1982
Certificate in Medical Technology, Clinical Laboratory Science/Medical Technology/Technologist
Inter-American University of Puerto Rico-San Germán Campus 1977 — 1981
Abbott Medical Optics September 2014 - Present
Medtronic November 2012 - October 2014
Pall Life Sciences November 2010 - November 2012
Pall Life Sciences 2010 - September 2012
Angiotech July 2008 - December 2010
Cordis LLC August 2006 - July 2008
Cordis, Johnson & Johnson August 2006 - July 2008
Cordis Corporation a Johnson and Johnson company August 2006 - July 2008
Cordis 2003 - 2008
Cordis, a Johnson and Johnson Company 2003 - 2006
Skills
CAPA, ISO 13485, FDA, Quality System, V&V, Regulatory Affairs, Sterilization, Medical Devices, Laboratory, Quality Management, Supplier Quality, ISO 14971, Quality Assurance, GxP, Design Control, Root Cause Analysis, Change Control, ISO, DMAIC, Sop, GMP, GLP, Computer System..., Validation, FMEA, Quality Control, Minitab, Quality Auditing, Design of Experiments, 21 CFR Part 11, Iso 9000, Six Sigma, Technology Transfer, GAMP, Process Simulation, CQE, FDA GMP, Medical Device Directive, LIMS, CE marking, Biopharmaceuticals, CQA, Trackwise, Aseptic Processing, 21 CFR, SPC, Regulatory Requirements, Biocompatibility, Calibration, PMA
Education
Inter American University School of Medical Technology 1981 — 1982
Certificate in Medical Technology, Clinical Laboratory Science/Medical Technology/Technologist
Inter-American University of Puerto Rico-San Germán Campus 1977 — 1981
Lewis Lefteroff Lewis Lefteroff's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 2000 - 2006
Job Managing Member at Opus Solutions, LLC
Industry Hospital & Health Care
Experience
Opus Solutions, LLC July 2011 - Present
ValuMetrix Services, Johnson & Johnson February 2010 - July 2011
ValuMetrix Services, Johnson & Johnson June 2006 - February 2010
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY 2000 - 2006
Cordis September 2004 - August 2005
Skills
Change Management, Lean Healthcare, Operations Management, Process Excellence, Lean Manufacturing, Industrial Engineering, Kaizen, Value Stream Mapping, Six Sigma, Operational Excellence, Continuous Improvement, DMAIC, Lean Sigma, 5S, Process Improvement, Healthcare, Quality Systems, Performance Improvement, Leadership Development, Strategy Development, Medical Devices, Change Leadership, Organizational..., Problem Solving, Coaching, Quality Improvement, Service Improvement, Strategy, Process Engineering, Cross-functional Team..., Quality System, Supply Chain, Business Process..., Management, Quality Management, Root Cause Analysis, Training, Project Management, Black Belt, TQM, Minitab
Education
University of Miami 1996 — 2001
Master of Science, Industrial Engineering
University of Miami
Masters of Industrial Engineering
Opus Solutions, LLC July 2011 - Present
ValuMetrix Services, Johnson & Johnson February 2010 - July 2011
ValuMetrix Services, Johnson & Johnson June 2006 - February 2010
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY 2000 - 2006
Cordis September 2004 - August 2005
Skills
Change Management, Lean Healthcare, Operations Management, Process Excellence, Lean Manufacturing, Industrial Engineering, Kaizen, Value Stream Mapping, Six Sigma, Operational Excellence, Continuous Improvement, DMAIC, Lean Sigma, 5S, Process Improvement, Healthcare, Quality Systems, Performance Improvement, Leadership Development, Strategy Development, Medical Devices, Change Leadership, Organizational..., Problem Solving, Coaching, Quality Improvement, Service Improvement, Strategy, Process Engineering, Cross-functional Team..., Quality System, Supply Chain, Business Process..., Management, Quality Management, Root Cause Analysis, Training, Project Management, Black Belt, TQM, Minitab
Education
University of Miami 1996 — 2001
Master of Science, Industrial Engineering
University of Miami
Masters of Industrial Engineering
Cliff Dwyer Cliff Dwyer's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 1998 - 2007
Job Director, Advanced Design at Mentor Worldwide LLC
Industry Medical Devices
Experience
Mentor Worldwide LLC December 2014 - Present
Linguaflex Inc. April 2007 - December 2014
Cordis Endovascular March 1997 - April 2007
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY 1998 - 2007
NDC 2002 - 2004
C.R. Bard July 1991 - December 1997
C. R. Bard (Implants, Vascular Systems, CardioVascular, Ventures and IMPRA divisions) 1989 - 1997
TPV Energy Systems, Inc. December 1986 - June 1991
Skills
R&D, Design Control, Cross-functional Team..., Manufacturing, Medical Devices, Commercialization, Start-ups, FDA, Strategy, Testing, Clinical Trials, ISO 13485, Product Development, Biomedical Engineering, Design of Experiments
Education
Florida Atlantic University 1999 — 2001
MBA
Wentworth Institute of Technology 1989 — 1995
BSTM
Mentor Worldwide LLC December 2014 - Present
Linguaflex Inc. April 2007 - December 2014
Cordis Endovascular March 1997 - April 2007
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY 1998 - 2007
NDC 2002 - 2004
C.R. Bard July 1991 - December 1997
C. R. Bard (Implants, Vascular Systems, CardioVascular, Ventures and IMPRA divisions) 1989 - 1997
TPV Energy Systems, Inc. December 1986 - June 1991
Skills
R&D, Design Control, Cross-functional Team..., Manufacturing, Medical Devices, Commercialization, Start-ups, FDA, Strategy, Testing, Clinical Trials, ISO 13485, Product Development, Biomedical Engineering, Design of Experiments
Education
Florida Atlantic University 1999 — 2001
MBA
Wentworth Institute of Technology 1989 — 1995
BSTM
Kahlilah Jennings Guyah's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience June 2000 - October 2007
Job Environmental Health & Safety (EHS) Consultant
Industry Management Consulting
Experience
Specialty Technical Consultants (STC) May 2014 - Present
EHS Compliance Services Inc. June 2011 - Present
Acro Service Corp November 2012 - August 2014
Watson Pharmaceuticals April 2008 - May 2009
Hamilton Sundstrand November 2007 - April 2008
Cordis Corporation a Johnson and Johnson Company June 2000 - October 2007
Cordis Neurovascular a Johnson & Johnson Co. 2002 - 2005
Skills
EHS, ISO 14001, Hazardous Waste..., EHS Training Creation &..., Biomedical Waste..., Bloodborne Pathogens, Stormwater Management, Wastewater, Domestic &..., EHS Audits, EHS Management Systems, OSHAS 18001, SPCC Plans, Emergency Response Plans, Emergency Management, Hazardous Materials..., Compliance Reporting, Occupational Health, Environmental Awareness, Environmental Auditing, International, Waste Management, Hazardous Materials, Industrial Hygiene, Waste, Manufacturing, ISO, Workplace Safety, Industrial Safety, Environmental..., Root Cause Analysis, Environmental Compliance, Hazard Analysis, Ergonomics, Hazard Recognition, Safety Management..., Process Safety, EPA, Remediation, Risk Assessment, Accident Investigation, Incident Investigation, Safety Engineering, OHSAS 18001
Education
Penn State University 1998 — 2000
MS, Chemistry
Emory University 1994 — 1998
Bachelor of Science, Chemistry
Specialty Technical Consultants (STC) May 2014 - Present
EHS Compliance Services Inc. June 2011 - Present
Acro Service Corp November 2012 - August 2014
Watson Pharmaceuticals April 2008 - May 2009
Hamilton Sundstrand November 2007 - April 2008
Cordis Corporation a Johnson and Johnson Company June 2000 - October 2007
Cordis Neurovascular a Johnson & Johnson Co. 2002 - 2005
Skills
EHS, ISO 14001, Hazardous Waste..., EHS Training Creation &..., Biomedical Waste..., Bloodborne Pathogens, Stormwater Management, Wastewater, Domestic &..., EHS Audits, EHS Management Systems, OSHAS 18001, SPCC Plans, Emergency Response Plans, Emergency Management, Hazardous Materials..., Compliance Reporting, Occupational Health, Environmental Awareness, Environmental Auditing, International, Waste Management, Hazardous Materials, Industrial Hygiene, Waste, Manufacturing, ISO, Workplace Safety, Industrial Safety, Environmental..., Root Cause Analysis, Environmental Compliance, Hazard Analysis, Ergonomics, Hazard Recognition, Safety Management..., Process Safety, EPA, Remediation, Risk Assessment, Accident Investigation, Incident Investigation, Safety Engineering, OHSAS 18001
Education
Penn State University 1998 — 2000
MS, Chemistry
Emory University 1994 — 1998
Bachelor of Science, Chemistry
Thomas Patch's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience February 2001 - Present
Job Principle Engineer at Cordis
Industry Medical Devices
Experience
Cordis February 2001 - Present
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY February 2001 - Present
Sage Products 1996 - 2001
Skills
Design Control, Design of Experiments, V&V, R&D, Biomedical Engineering, Medical Devices, FDA, DMAIC, Lean Manufacturing, Validation, ISO 13485, CAPA, Minitab, Quality System, ISO 14971, SPC, GMP, FMEA, Catheters, Solidworks
Education
Florida International University 2005 — 2006
Master, Engineering Management
University of Massachusetts Lowell 1981 — 1985
Cordis February 2001 - Present
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY February 2001 - Present
Sage Products 1996 - 2001
Skills
Design Control, Design of Experiments, V&V, R&D, Biomedical Engineering, Medical Devices, FDA, DMAIC, Lean Manufacturing, Validation, ISO 13485, CAPA, Minitab, Quality System, ISO 14971, SPC, GMP, FMEA, Catheters, Solidworks
Education
Florida International University 2005 — 2006
Master, Engineering Management
University of Massachusetts Lowell 1981 — 1985
Al Stancampiano's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 2001 - 2004
Job Program Manager at Vention Medical
Industry Medical Devices
Experience
TDC Medical: A Vention Medical Company January 2014 - Present
CardioFocus January 2010 - Present
CardioFocus October 2005 - December 2009
LeMaitre Vascular April 2004 - October 2005
Cordis Corporation a Johnson and Johnson Company 2001 - 2004
Moog Inc. 1998 - 2001
Dept of Defense - Naval Air Warfare Center, Aircraft Division 1996 - 1998
Skills
Quality System, Solidworks, ISO 13485, Injection Molding, R&D, Validation, Plastics, Product Development, Manufacturing, Design of Experiments, Biomedical Engineering, FMEA, Process Improvement, CAPA, ISO 14971, V&V, Design for Manufacturing, Engineering, ISO
Education
State University of New York at Buffalo 1987 — 1996
Master of Science (MS), Mechanical & Biomedical Engineering
TDC Medical: A Vention Medical Company January 2014 - Present
CardioFocus January 2010 - Present
CardioFocus October 2005 - December 2009
LeMaitre Vascular April 2004 - October 2005
Cordis Corporation a Johnson and Johnson Company 2001 - 2004
Moog Inc. 1998 - 2001
Dept of Defense - Naval Air Warfare Center, Aircraft Division 1996 - 1998
Skills
Quality System, Solidworks, ISO 13485, Injection Molding, R&D, Validation, Plastics, Product Development, Manufacturing, Design of Experiments, Biomedical Engineering, FMEA, Process Improvement, CAPA, ISO 14971, V&V, Design for Manufacturing, Engineering, ISO
Education
State University of New York at Buffalo 1987 — 1996
Master of Science (MS), Mechanical & Biomedical Engineering
Armando Graupera's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 2007 - Present
Job Principal Engineer / MBB at Cordis Corp
Industry Medical Devices
Experience
Cordis Corp September 2007 - Present
Cordis Corporation a Johnson and Johnson company 2007 - Present
Cordis a Johnson & Johnson Co. 1986 - Present
Cordis Corportion 1986 - 2009
Cordis Dow 1984 - 1986
Education
University of Miami 2000 — 2004
PhD-ABD, Industrial Engineering
University of Miami 1997 — 1999
MSIE, Industrial Engineering
University of South Florida 1982 — 1984
BSChE, Chemical & Mechanical Engienering
Florida International University 1979 — 1981
BSCh, Chemistry and Physics
Cordis Corp September 2007 - Present
Cordis Corporation a Johnson and Johnson company 2007 - Present
Cordis a Johnson & Johnson Co. 1986 - Present
Cordis Corportion 1986 - 2009
Cordis Dow 1984 - 1986
Education
University of Miami 2000 — 2004
PhD-ABD, Industrial Engineering
University of Miami 1997 — 1999
MSIE, Industrial Engineering
University of South Florida 1982 — 1984
BSChE, Chemical & Mechanical Engienering
Florida International University 1979 — 1981
BSCh, Chemistry and Physics
Bob Bogren's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 1992 - 1997
Job Project Manager at ConMed Linvatec
Industry Medical Devices
Experience
ConMed Linvatec December 1999 - Present
Cordis Corporation, a Johnson and Johnson company 1992 - 1997
Skills
Stents, Manufacturing, Design of Experiments, V&V, Minitab, SPC, Design for Manufacturing, Injection Molding, Medical Devices, Product Development, ISO 13485, Lean Manufacturing, DMAIC, R&D, Validation, Design Control, Plastics, Quality System, ISO, Six Sigma, Process Improvement, Project Management, Manufacturing..., FMEA, Angioplasty, FDA, Cross-functional Team..., Continuous Improvement, CAPA, GMP, Kaizen, Product Launch, Solidworks, Quality Assurance, Biomedical Engineering, Process Simulation, Market Development, Process Engineering, Root Cause Analysis, Machine Tools, Commercialization
Education
University of Massachusetts Lowell 1985 — 1990
B.S., Plastics Engineering
ConMed Linvatec December 1999 - Present
Cordis Corporation, a Johnson and Johnson company 1992 - 1997
Skills
Stents, Manufacturing, Design of Experiments, V&V, Minitab, SPC, Design for Manufacturing, Injection Molding, Medical Devices, Product Development, ISO 13485, Lean Manufacturing, DMAIC, R&D, Validation, Design Control, Plastics, Quality System, ISO, Six Sigma, Process Improvement, Project Management, Manufacturing..., FMEA, Angioplasty, FDA, Cross-functional Team..., Continuous Improvement, CAPA, GMP, Kaizen, Product Launch, Solidworks, Quality Assurance, Biomedical Engineering, Process Simulation, Market Development, Process Engineering, Root Cause Analysis, Machine Tools, Commercialization
Education
University of Massachusetts Lowell 1985 — 1990
B.S., Plastics Engineering
Henry Comartin's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 1992 - 2000
Job Sr Ops Mgr at Tissue
Industry Medical Devices
Experience
Tissuetech October 2013 - Present
Biomet 3i November 2007 - October 2013
Biomet 3i January 2002 - May 2006
Biomet 3i November 2000 - December 2001
Cordis - Johnson & Johnson April 1998 - April 2000
Cordis 1998 - 2000
Johnson & Johnson- Cordis 1997 - 2000
Johnson & Johnson- Cordis 1997 - 2000
Cordis Corporation a Johnson and Johnson Company 1992 - 2000
Cordis, a Johnson & Johnson company 1992 - 2000
Skills
ISO 13485, Medical Devices, Quality System, V&V, Design Control, FDA, Quality Assurance, Six Sigma, 21 CFR Part 11, Biomedical Engineering, CAPA, Change Control, Continuous Improvement, DMAIC, Design of Experiments, FMEA, GMP, Global Marketing, ISO, ISO 14971, Kaizen, Manufacturing..., Manufacturing Operations, Minitab, Market Development, Process Improvement, Product Development, Quality Control, Regulatory Affairs, Root Cause Analysis, Sop, Supplier Quality, Surgical Instruments, Technology Transfer, Validation, Value Stream Mapping, Lean Manufacturing, Process Engineering, Quality Auditing, R, 5S, Capital Equipment, Contract Manufacturing, Cross-functional Team..., Disposables, Manufacturing, Quality Management, SOP, SPC, Black Belt
Education
Florida International University - College of Business 1991 — 1994
MBA, Internal Business
University of Miami 1984 — 1988
BS, Industrial Engineering -Mfg
Tissuetech October 2013 - Present
Biomet 3i November 2007 - October 2013
Biomet 3i January 2002 - May 2006
Biomet 3i November 2000 - December 2001
Cordis - Johnson & Johnson April 1998 - April 2000
Cordis 1998 - 2000
Johnson & Johnson- Cordis 1997 - 2000
Johnson & Johnson- Cordis 1997 - 2000
Cordis Corporation a Johnson and Johnson Company 1992 - 2000
Cordis, a Johnson & Johnson company 1992 - 2000
Skills
ISO 13485, Medical Devices, Quality System, V&V, Design Control, FDA, Quality Assurance, Six Sigma, 21 CFR Part 11, Biomedical Engineering, CAPA, Change Control, Continuous Improvement, DMAIC, Design of Experiments, FMEA, GMP, Global Marketing, ISO, ISO 14971, Kaizen, Manufacturing..., Manufacturing Operations, Minitab, Market Development, Process Improvement, Product Development, Quality Control, Regulatory Affairs, Root Cause Analysis, Sop, Supplier Quality, Surgical Instruments, Technology Transfer, Validation, Value Stream Mapping, Lean Manufacturing, Process Engineering, Quality Auditing, R, 5S, Capital Equipment, Contract Manufacturing, Cross-functional Team..., Disposables, Manufacturing, Quality Management, SOP, SPC, Black Belt
Education
Florida International University - College of Business 1991 — 1994
MBA, Internal Business
University of Miami 1984 — 1988
BS, Industrial Engineering -Mfg
Bruce Hoo's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 1999 - 2003
Job Sr. Manufacturing Engineer at Spectranetics
Industry Medical Devices
Experience
Spectranetics November 2007 - Present
Cordis Corp. January 2005 - November 2007
Cordis, Johnson & Johnson 2005 - 2005
Boston Scientific 2004 - 2004
Cordis Corporation, a Johnson and Johnson company 1999 - 2003
Boston Scientific 1998 - 1999
Education
Florida International University
MS, Engineering Management
The George Washington University 1994 — 1998
BS, Mechanical Engineering
Spectranetics November 2007 - Present
Cordis Corp. January 2005 - November 2007
Cordis, Johnson & Johnson 2005 - 2005
Boston Scientific 2004 - 2004
Cordis Corporation, a Johnson and Johnson company 1999 - 2003
Boston Scientific 1998 - 1999
Education
Florida International University
MS, Engineering Management
The George Washington University 1994 — 1998
BS, Mechanical Engineering
Gordon Hoath's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY 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
Tricia Ramdial's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience May 2012 - Present
Job Principal Sterilization Engineer, Technical Operations at Cordis Corporation, a Johnson and Johnson Company
Industry Medical Devices
Experience
Cordis Corporation, a Johnson and Johnson Company May 2012 - Present
Cordis Corporation, a Johnson & Johnson Company August 2010 - May 2012
Cordis Corporation, a Johnson & Johnson Company July 2005 - July 2010
Cordis Corporation, a Johnson & Johnson Company November 1999 - June 2005
Skills
CAPA, Microbiology, Chemistry, Sterilization, Technical Training, Training &..., Training Delivery
Education
Barry University 2002 — 2005
Masters, Biomedical Science
University of Florida
BS, Microbiology and Cell Science
Cordis Corporation, a Johnson and Johnson Company May 2012 - Present
Cordis Corporation, a Johnson & Johnson Company August 2010 - May 2012
Cordis Corporation, a Johnson & Johnson Company July 2005 - July 2010
Cordis Corporation, a Johnson & Johnson Company November 1999 - June 2005
Skills
CAPA, Microbiology, Chemistry, Sterilization, Technical Training, Training &..., Training Delivery
Education
Barry University 2002 — 2005
Masters, Biomedical Science
University of Florida
BS, Microbiology and Cell Science
Alberto G. Paret's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience May 1993 - 1996
Job QA Fellow Microbiology & Sterilization at Johnson & Johnson
Industry Medical Devices
Experience
Johnson & Johnson January 2014 - Present
Cordis August 2009 - Present
Cordis August 2007 - February 2009
Cordis April 2005 - November 2007
J&J 2002 - 2005
Cordis 1996 - 1998
Cordis Corporation, a Johnson and Johnson Company May 1993 - 1996
Skills
Environmental Monitoring, Microbiology, Aseptic Technique, Start-ups, Auditing, Aseptic Processing, GMP, Sterilization, Project Management, CAPA, FDA, V&V, Medical Devices, LIMS, Change Control, ISO 13485, Design Control, Process Improvement, Manufacturing, Six Sigma, Lean Manufacturing, Validation, Quality Assurance, Quality System, DMAIC, Laboratory, 21 CFR Part 11, ISO, ISO 14971, GLP, USP, Quality Auditing, Clean Rooms, Computer System..., Compliance, GxP, 21 CFR, Quality Control
Education
Barry University 1993 — 1994
Masters in Biomedical Sciences, Physiology, Microbiology
Barry University 1988 — 1990
Bachelor, Biology, Marine Biology, Molecular biology
Northeastern Illinois University 1984 — 1987
Biology
Von Steuben H.S. Chicago, IL 1979 — 1983
Diploma, General Study
Johnson & Johnson January 2014 - Present
Cordis August 2009 - Present
Cordis August 2007 - February 2009
Cordis April 2005 - November 2007
J&J 2002 - 2005
Cordis 1996 - 1998
Cordis Corporation, a Johnson and Johnson Company May 1993 - 1996
Skills
Environmental Monitoring, Microbiology, Aseptic Technique, Start-ups, Auditing, Aseptic Processing, GMP, Sterilization, Project Management, CAPA, FDA, V&V, Medical Devices, LIMS, Change Control, ISO 13485, Design Control, Process Improvement, Manufacturing, Six Sigma, Lean Manufacturing, Validation, Quality Assurance, Quality System, DMAIC, Laboratory, 21 CFR Part 11, ISO, ISO 14971, GLP, USP, Quality Auditing, Clean Rooms, Computer System..., Compliance, GxP, 21 CFR, Quality Control
Education
Barry University 1993 — 1994
Masters in Biomedical Sciences, Physiology, Microbiology
Barry University 1988 — 1990
Bachelor, Biology, Marine Biology, Molecular biology
Northeastern Illinois University 1984 — 1987
Biology
Von Steuben H.S. Chicago, IL 1979 — 1983
Diploma, General Study
Garrick Horner's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 1999 - January 2006
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
Veronica Reott's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience September 2006 - December 2008
Job Engineering Consultant at Naglreiter Consulting
Industry Medical Devices
Experience
Naglreiter Consulting May 2013 - Present
SafeStitch February 2012 - April 2013
Cordis June 2010 - February 2012
Cordis January 2010 - January 2011
Cordis March 2009 - December 2009
Cordis Corporation, a Johnson and Johnson Company September 2006 - December 2008
Education
Stetson University 2001 — 2005
BS, Mathematics
Universidad Complutense de Madrid
Naglreiter Consulting May 2013 - Present
SafeStitch February 2012 - April 2013
Cordis June 2010 - February 2012
Cordis January 2010 - January 2011
Cordis March 2009 - December 2009
Cordis Corporation, a Johnson and Johnson Company September 2006 - December 2008
Education
Stetson University 2001 — 2005
BS, Mathematics
Universidad Complutense de Madrid
Bill Eifert's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 2006 - 2008
Job Validation Consultant at Edwards Lifesciences
Industry Medical Devices
Experience
Edwards Lifesciences March 2015 - July 2015
Edwards Lifesciences October 2013 - March 2015
Edwards Lifesciences January 2013 - September 2013
Edwards Lifesciences March 2011 - December 2012
Edwards Lifesciences March 2010 - March 2011
HeartWare Inc October 2009 - February 2010
Cordis Corporation, a Johnson and Johnson Company 2006 - 2008
Cordis Corporation, a Johnson and Johnson Company 2002 - 2006
Cordis Corporation, a Johnson and Johnson Company 2000 - 2002
Cordis Corporation, a Johnson and Johnson Company 1996 - 2000
Skills
Materials Science, Visio, PMP, SAP, Polymers, Validation, Design Control, Design of Experiments, Minitab, Quality Auditing, Technology Transfer, Engineering Management, Project Management, Packaging, ISO 13485, Medical Devices, V&V, CAPA, R&D, Six Sigma, FMEA, DMAIC, Manufacturing, Lean Manufacturing, Cross-functional Team..., Manufacturing..., Process Engineering, Process Excellence, Black Belt, Value Stream Mapping, Engineering, 21 CFR Part 11, Quality System, ISO, Quality Assurance, Root Cause Analysis, GMP, FDA, Continuous Improvement, Biomedical Engineering, Quality Control, Testing, Process Simulation, SPC, Product Development, Commercialization, ISO 14971, Change Control, Quality Management, Design for Manufacturing
Education
Florida International University 1977 — 1980
BA, Psychology: course study related to industry and human behavior
Miami Dade College 1974 — 1976
AA, General Education: major courses included Physics, Chemistry, Materials of Industry, Social Science
Penn State University 1970 — 1972
Mechanical Engineering
Industrial Management Institute 1966 — 1968
Tool Design, Tool Design, Strength of Materials, Motion & Time Study, Mathematics, Physics
Edwards Lifesciences March 2015 - July 2015
Edwards Lifesciences October 2013 - March 2015
Edwards Lifesciences January 2013 - September 2013
Edwards Lifesciences March 2011 - December 2012
Edwards Lifesciences March 2010 - March 2011
HeartWare Inc October 2009 - February 2010
Cordis Corporation, a Johnson and Johnson Company 2006 - 2008
Cordis Corporation, a Johnson and Johnson Company 2002 - 2006
Cordis Corporation, a Johnson and Johnson Company 2000 - 2002
Cordis Corporation, a Johnson and Johnson Company 1996 - 2000
Skills
Materials Science, Visio, PMP, SAP, Polymers, Validation, Design Control, Design of Experiments, Minitab, Quality Auditing, Technology Transfer, Engineering Management, Project Management, Packaging, ISO 13485, Medical Devices, V&V, CAPA, R&D, Six Sigma, FMEA, DMAIC, Manufacturing, Lean Manufacturing, Cross-functional Team..., Manufacturing..., Process Engineering, Process Excellence, Black Belt, Value Stream Mapping, Engineering, 21 CFR Part 11, Quality System, ISO, Quality Assurance, Root Cause Analysis, GMP, FDA, Continuous Improvement, Biomedical Engineering, Quality Control, Testing, Process Simulation, SPC, Product Development, Commercialization, ISO 14971, Change Control, Quality Management, Design for Manufacturing
Education
Florida International University 1977 — 1980
BA, Psychology: course study related to industry and human behavior
Miami Dade College 1974 — 1976
AA, General Education: major courses included Physics, Chemistry, Materials of Industry, Social Science
Penn State University 1970 — 1972
Mechanical Engineering
Industrial Management Institute 1966 — 1968
Tool Design, Tool Design, Strength of Materials, Motion & Time Study, Mathematics, Physics
Jackson Lordeus's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 1993 - August 2011
Job Senior R&D Technician at Cordis Neurovascular
Industry Medical Devices
Experience
Biosense Webster January 2012 - Present
Cordis 1993 - Present
Cordis Corporation a Johnson and Johnson Company 1993 - August 2011
Cordis Neurovascular 1993 - 2007
Education
Miami Dade College 1990 — 1992
A. S. degree, Electronic Engineering
Biosense Webster January 2012 - Present
Cordis 1993 - Present
Cordis Corporation a Johnson and Johnson Company 1993 - August 2011
Cordis Neurovascular 1993 - 2007
Education
Miami Dade College 1990 — 1992
A. S. degree, Electronic Engineering
Dennis Griffin's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 1998 - 2013
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
Rosanne Terraciano's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 1996 - 1997
Job Vice President, Operations at Vascular Therapies, Inc.
Industry Medical Devices
Experience
Vascular Therapies Inc. October 2005 - Present
Datascope (Collagen Products Division) 1997 - 2005
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY 1996 - 1997
W.R Grace National Medical Care Division 1990 - 1995
Meadox Medicals 1982 - 1986
Skills
Market Research, Business Units, Business Development, Income Statement, Medical Devices, Competitive Analysis, ISO 13485, Cross-functional Team..., Product Marketing, Sales Operations, Start-ups, Product Development, Business Planning, P&L Management, Product Launch, P&L, FDA, Management, Cardiology, Strategic Planning, Marketing Strategy, Commercialization, Global Marketing
Education
Saint Peter's University 1980 — 1985
BS, Health Care Management
Englewood Hospital School of Nursing
Diploma, Nursing
Vascular Therapies Inc. October 2005 - Present
Datascope (Collagen Products Division) 1997 - 2005
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY 1996 - 1997
W.R Grace National Medical Care Division 1990 - 1995
Meadox Medicals 1982 - 1986
Skills
Market Research, Business Units, Business Development, Income Statement, Medical Devices, Competitive Analysis, ISO 13485, Cross-functional Team..., Product Marketing, Sales Operations, Start-ups, Product Development, Business Planning, P&L Management, Product Launch, P&L, FDA, Management, Cardiology, Strategic Planning, Marketing Strategy, Commercialization, Global Marketing
Education
Saint Peter's University 1980 — 1985
BS, Health Care Management
Englewood Hospital School of Nursing
Diploma, Nursing
Maria Polanco's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience January 2007 - June 2008
Job Digital Campaigns Marketing at TMF Group
Industry Marketing and Advertising
Experience
TMF Group August 2014 - Present
TMF Group July 2013 - July 2014
Media 8 May 2012 - May 2013
Multiplica March 2011 - May 2012
Diamond Public Relations June 2008 - September 2009
Cordis Corporation, a Johnson and Johnson Company January 2007 - June 2008
Skills
Fully bilingual in..., Proficiency in Office..., Working remotely with..., Information..., Content management..., Project Management, Spanish, Management, Business Development, Quality Assurance, Account Management, Digital Marketing, Marketing, Project Planning, SEM, E-commerce, Event Planning, Social Media Marketing, CRM, Media Relations, Analytics, Press Releases, Mobile Devices, Strategy, Sales, Online Advertising
Education
University of London 2009 — 2011
Masters, Transnational Communications & Global Media
Florida International University 2002 — 2006
Bachelors, International Business, Marketing & Finance
TMF Group August 2014 - Present
TMF Group July 2013 - July 2014
Media 8 May 2012 - May 2013
Multiplica March 2011 - May 2012
Diamond Public Relations June 2008 - September 2009
Cordis Corporation, a Johnson and Johnson Company January 2007 - June 2008
Skills
Fully bilingual in..., Proficiency in Office..., Working remotely with..., Information..., Content management..., Project Management, Spanish, Management, Business Development, Quality Assurance, Account Management, Digital Marketing, Marketing, Project Planning, SEM, E-commerce, Event Planning, Social Media Marketing, CRM, Media Relations, Analytics, Press Releases, Mobile Devices, Strategy, Sales, Online Advertising
Education
University of London 2009 — 2011
Masters, Transnational Communications & Global Media
Florida International University 2002 — 2006
Bachelors, International Business, Marketing & Finance
Tyler Binney's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience April 2006 - March 2010
Job Vice President of Sales at NeoTract
Industry Medical Devices
Experience
NeoTract September 2014 - Present
Acclarent, a Johnson and Johnson company September 2012 - September 2014
Acclarent, a Johnson and Johnson company March 2010 - September 2012
Cordis Corporation, a Johnson and Johnson Company April 2006 - March 2010
Cordis Corporation, a Johnson and Johnson Company April 2004 - April 2006
Cordis Corporation, a Johnson and Johnson Company April 2003 - April 2004
Cordis Corporation, a Johnson and Johnson Company August 2000 - April 2003
Cordis Corporation, a Johnson and Johnson Company January 2000 - August 2000
Warner Lambert, Parke-Davis Pharmaceutical Division January 1997 - January 2000
Medirisk June 1996 - January 1997
Skills
Interventional..., Medical Devices, Product Launch, Hospitals, Healthcare, Operating Room, Cardiology, Cath Lab, Surgery, Clinical Research, Capital Equipment, Disposables, Market Development, Sales Operations, Vascular, FDA, Interventional Radiology, Surgeons, Surgical Instruments, Neurosurgery, Orthopedic, Urology, OB/GYN, Vascular Surgery
Education
Presbyterian College 1992 — 1996
B.S.
NeoTract September 2014 - Present
Acclarent, a Johnson and Johnson company September 2012 - September 2014
Acclarent, a Johnson and Johnson company March 2010 - September 2012
Cordis Corporation, a Johnson and Johnson Company April 2006 - March 2010
Cordis Corporation, a Johnson and Johnson Company April 2004 - April 2006
Cordis Corporation, a Johnson and Johnson Company April 2003 - April 2004
Cordis Corporation, a Johnson and Johnson Company August 2000 - April 2003
Cordis Corporation, a Johnson and Johnson Company January 2000 - August 2000
Warner Lambert, Parke-Davis Pharmaceutical Division January 1997 - January 2000
Medirisk June 1996 - January 1997
Skills
Interventional..., Medical Devices, Product Launch, Hospitals, Healthcare, Operating Room, Cardiology, Cath Lab, Surgery, Clinical Research, Capital Equipment, Disposables, Market Development, Sales Operations, Vascular, FDA, Interventional Radiology, Surgeons, Surgical Instruments, Neurosurgery, Orthopedic, Urology, OB/GYN, Vascular Surgery
Education
Presbyterian College 1992 — 1996
B.S.
Chuck Ryan's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience April 1997 - January 2002
Job Senior Manager, Regulatory Affairs at Bayer HealthCare
Industry Medical Devices
Experience
Bayer HealthCare - Medical Care June 2014 - Present
Bayer HealthCare - Diabetes Care June 2013 - June 2014
Bayer HealthCare - Diabetes Care July 2011 - June 2013
ConvaTec February 2010 - July 2011
Johnson & Johnson Health Care Systems Inc. September 2006 - January 2010
Johnson & Johnson Gateway, LLC February 2002 - August 2006
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY April 1997 - January 2002
Bausch & Lomb October 1996 - April 1997
Skills
Regulatory Affairs, FDA, Medical Devices, CAPA, Validation, Regulatory Requirements, V&V, GMP, Computer System..., ISO 13485, 21 CFR Part 11, Quality System, Change Control, Quality Assurance, SOP, Quality Auditing, GxP, Project Management, Staff Management, Internet Compliance, Quality and Compliance, US Medical Device..., Canadian Medical Device..., Advertising and..., Medical Device Labeling, QSR, In Vitro Diagnostic..., AdvaMed Working Groups, ISO Standards, Blood Glucose..., Regulatory Intelligence, Import/Export, European Medical Device..., Spanish to English..., Health Canada, European Commission, CMDCAS, Privacy Compliance, Information Security..., Orthopedic Medical..., Cardiovascular Medical..., Cosmetics, Monograph Drugs, General Hospital..., Electronic Labeling, EUCOMED Working Groups, Strategic Planning, Unique Device...
Education
The Graduate Center, City University of New York 1990 — 1992
MA
Binghamton University 1985 — 1987
BA
State University of New York Empire State College 1992 — 1993
BA
Bayer HealthCare - Medical Care June 2014 - Present
Bayer HealthCare - Diabetes Care June 2013 - June 2014
Bayer HealthCare - Diabetes Care July 2011 - June 2013
ConvaTec February 2010 - July 2011
Johnson & Johnson Health Care Systems Inc. September 2006 - January 2010
Johnson & Johnson Gateway, LLC February 2002 - August 2006
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY April 1997 - January 2002
Bausch & Lomb October 1996 - April 1997
Skills
Regulatory Affairs, FDA, Medical Devices, CAPA, Validation, Regulatory Requirements, V&V, GMP, Computer System..., ISO 13485, 21 CFR Part 11, Quality System, Change Control, Quality Assurance, SOP, Quality Auditing, GxP, Project Management, Staff Management, Internet Compliance, Quality and Compliance, US Medical Device..., Canadian Medical Device..., Advertising and..., Medical Device Labeling, QSR, In Vitro Diagnostic..., AdvaMed Working Groups, ISO Standards, Blood Glucose..., Regulatory Intelligence, Import/Export, European Medical Device..., Spanish to English..., Health Canada, European Commission, CMDCAS, Privacy Compliance, Information Security..., Orthopedic Medical..., Cardiovascular Medical..., Cosmetics, Monograph Drugs, General Hospital..., Electronic Labeling, EUCOMED Working Groups, Strategic Planning, Unique Device...
Education
The Graduate Center, City University of New York 1990 — 1992
MA
Binghamton University 1985 — 1987
BA
State University of New York Empire State College 1992 — 1993
BA
Insley Allen's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience January 2006 - August 2006
Job Senior Sales Coordinator at London Bridge Trading Company, Ltd.
Industry Defense & Space
Experience
London Bridge Trading Company September 2009 - Present
Pratt Industries June 2007 - February 2009
Cordis Corporation, a Johnson and Johnson Company January 2006 - August 2006
Skills
Packaging, Testing, Packaging Engineering, Medical Devices, Manufacturing, Product Development, Continuous Improvement, Plastics, Corrugated, Cross-functional Team..., Sales Operations, Logistics, Sales, Quality Assurance, Management, New Business Development, Customer Service, Marketing, Purchasing, Trade Shows
Education
Clemson University 2002 — 2007
B.S., Packaging Science, Business
London Bridge Trading Company September 2009 - Present
Pratt Industries June 2007 - February 2009
Cordis Corporation, a Johnson and Johnson Company January 2006 - August 2006
Skills
Packaging, Testing, Packaging Engineering, Medical Devices, Manufacturing, Product Development, Continuous Improvement, Plastics, Corrugated, Cross-functional Team..., Sales Operations, Logistics, Sales, Quality Assurance, Management, New Business Development, Customer Service, Marketing, Purchasing, Trade Shows
Education
Clemson University 2002 — 2007
B.S., Packaging Science, Business
Juan Carlos Sandoval's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience October 1990 - August 2011
Job Medical Device Principal Technician
Industry Medical Devices
Experience
SafeStitch Medical January 2012 - Present
Safestitch Medical 2012 - 2012
Cordis Corporation a Johnson and Johnson Company October 1990 - August 2011
Cordis January 1996 - January 1997
Cordis January 1994 - January 1996
Cordis January 1992 - January 1994
Cordis January 1990 - January 1992
DELLARIZZA ENGINEERING CONSULTANTS May 1990 - October 1990
Florida International University January 1988 - January 1990
Skills
Scanning Electron..., Design of Experiments, Design Control, Medical Devices, V&V
Education
South Carolina State University 1982 — 1985
B.S, Mechanical Engineering Technology
SafeStitch Medical January 2012 - Present
Safestitch Medical 2012 - 2012
Cordis Corporation a Johnson and Johnson Company October 1990 - August 2011
Cordis January 1996 - January 1997
Cordis January 1994 - January 1996
Cordis January 1992 - January 1994
Cordis January 1990 - January 1992
DELLARIZZA ENGINEERING CONSULTANTS May 1990 - October 1990
Florida International University January 1988 - January 1990
Skills
Scanning Electron..., Design of Experiments, Design Control, Medical Devices, V&V
Education
South Carolina State University 1982 — 1985
B.S, Mechanical Engineering Technology
Carlos Sabater's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 2002 - 2008
Job Strategic New Product Manager at McNeil Healthcare LLC
Industry Pharmaceuticals
Experience
McNeil Healthcare LLC Packaging Section MangerMcNeil Consumer Healthcare LLC - PR2008 - 2009
McNeil Healthcare LLC 2008 - 2009
Cordis LLC 2002 - 2008
Cordis Corporation, a Johnson and Johnson Company 2002 - 2008
Education
Universidad de Puerto Rico 1986 — 1991
Bachelor in Science, Mechanical Engineering
McNeil Healthcare LLC Packaging Section MangerMcNeil Consumer Healthcare LLC - PR2008 - 2009
McNeil Healthcare LLC 2008 - 2009
Cordis LLC 2002 - 2008
Cordis Corporation, a Johnson and Johnson Company 2002 - 2008
Education
Universidad de Puerto Rico 1986 — 1991
Bachelor in Science, Mechanical Engineering
Grant Ayayee's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 1999 - 2004
Job Quality Engineer /Project Engineer
Industry Medical Devices
Experience
Aerotek April 2015 - Present
World Class Pharmaceutical Company January 2015 - March 2015
Pulse Technologies July 2013 - July 2014
Teleflex Medical April 2010 - December 2012
BBraun Medical Inc July 2007 - November 2010
Atlas Spine 2006 - 2007
Symphony Medical Inc November 2005 - August 2006
Symbiosis Medical Inc 2004 - 2006
Cordis Corporation a Johnson and Johnson Company 1999 - 2004
Cordis / Telectronics Pacing System 1990 - 1997
Skills
Medical Devices, FDA, Quality Assurance, Validation, Design Control, Manufacturing, Product Development, Reliability, Six Sigma, Engineering, Product Launch, Lean Manufacturing, ISO 13485, CAPA, Root Cause Analysis, SPC, ISO, GMP, V&V
Education
Barry University 2000 — 2004
BSc, Computer Engineering & Network Systems Engineering
Florida International University 1990 — 1992
Mechanical Engineering
Miami Dade College 1990 — 1992
AA, Mechanical Eengineering
Aerotek April 2015 - Present
World Class Pharmaceutical Company January 2015 - March 2015
Pulse Technologies July 2013 - July 2014
Teleflex Medical April 2010 - December 2012
BBraun Medical Inc July 2007 - November 2010
Atlas Spine 2006 - 2007
Symphony Medical Inc November 2005 - August 2006
Symbiosis Medical Inc 2004 - 2006
Cordis Corporation a Johnson and Johnson Company 1999 - 2004
Cordis / Telectronics Pacing System 1990 - 1997
Skills
Medical Devices, FDA, Quality Assurance, Validation, Design Control, Manufacturing, Product Development, Reliability, Six Sigma, Engineering, Product Launch, Lean Manufacturing, ISO 13485, CAPA, Root Cause Analysis, SPC, ISO, GMP, V&V
Education
Barry University 2000 — 2004
BSc, Computer Engineering & Network Systems Engineering
Florida International University 1990 — 1992
Mechanical Engineering
Miami Dade College 1990 — 1992
AA, Mechanical Eengineering
Jack Springer's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 2003 - 2006
Job Executive Consultant Medical Device and Diagnostics
Industry Medical Devices
Experience
Capture Vascular, Inc. September 2013 - Present
JDS Consulting; Medical Devices and Diagnostics January 2012 - Present
Vatrix Medical November 2011 - Present
Aneurysm Diagnostics December 2011 - Present
Micell Technologies 2013 - 2015
Micell Technologies 2013 - 2015
Medtronic April 2010 - August 2011
INVATEC May 2008 - April 2010
Neuromonics 2006 - 2008
Cordis Corporation a Johnson and Johnson Company 2003 - 2006
Skills
General Management, Product..., Business Development, Strategic Planning, Sales & Marketing..., Capital Raising, Start-up Leadership, Cross Functional Team..., Global Strategy, Market Development, International Sales and..., Portfolio Management, Medical Devices, Management Consulting, Strategic Consulting, Acquisition Integration, Six Sigma, Sales Process, Sales Rep Training, Strategic Negotiations, Executive Coaching, Executive Management, Cross-functional Team..., Regulatory Affairs, Cardiology, Strategic Partnerships, International Sales, FDA, Strategy, Capital Equipment, Sales Management, Competitive Analysis, Commercialization, Start-ups, Product Launch, Management, P&L Management, Operating Room, Mergers & Acquisitions, Surgeons, Leadership, Global Marketing, Surgical Instruments, ISO 13485, R&D, Interventional..., Sales Effectiveness
Education
University of Michigan Business School
Western Maryland College
Bachelor of Arts (B.A.), Political Science
Capture Vascular, Inc. September 2013 - Present
JDS Consulting; Medical Devices and Diagnostics January 2012 - Present
Vatrix Medical November 2011 - Present
Aneurysm Diagnostics December 2011 - Present
Micell Technologies 2013 - 2015
Micell Technologies 2013 - 2015
Medtronic April 2010 - August 2011
INVATEC May 2008 - April 2010
Neuromonics 2006 - 2008
Cordis Corporation a Johnson and Johnson Company 2003 - 2006
Skills
General Management, Product..., Business Development, Strategic Planning, Sales & Marketing..., Capital Raising, Start-up Leadership, Cross Functional Team..., Global Strategy, Market Development, International Sales and..., Portfolio Management, Medical Devices, Management Consulting, Strategic Consulting, Acquisition Integration, Six Sigma, Sales Process, Sales Rep Training, Strategic Negotiations, Executive Coaching, Executive Management, Cross-functional Team..., Regulatory Affairs, Cardiology, Strategic Partnerships, International Sales, FDA, Strategy, Capital Equipment, Sales Management, Competitive Analysis, Commercialization, Start-ups, Product Launch, Management, P&L Management, Operating Room, Mergers & Acquisitions, Surgeons, Leadership, Global Marketing, Surgical Instruments, ISO 13485, R&D, Interventional..., Sales Effectiveness
Education
University of Michigan Business School
Western Maryland College
Bachelor of Arts (B.A.), Political Science
James Patak's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 1990 - 2004
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
Fertac Bilge's CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY Experience 2003 - 2006
Job Consultant at Validant
Industry Medical Devices
Experience
Validant June 2015 - Present
Helix Medical October 2013 - Present
Terumo Medical Corporation March 2011 - April 2013
Covidien December 2009 - January 2011
Thoratec 2006 - 2009
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY 2003 - 2006
Medtronic Vascular 1999 - 2003
Mentor Medical Systems 1994 - 1998
Skills
Medical Devices, Product Development, ISO 13485, Design Control, Project Management, FDA, Biomedical Engineering, Quality System, CAPA, V&V, R&D, Cross-functional Team...
Education
The University of Texas Southwestern Medical Center at Dallas 1977 — 1981
Ph.D., Biomedical engineering
Texas A&M University
M.S., Biomedical Engineering
Validant June 2015 - Present
Helix Medical October 2013 - Present
Terumo Medical Corporation March 2011 - April 2013
Covidien December 2009 - January 2011
Thoratec 2006 - 2009
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY 2003 - 2006
Medtronic Vascular 1999 - 2003
Mentor Medical Systems 1994 - 1998
Skills
Medical Devices, Product Development, ISO 13485, Design Control, Project Management, FDA, Biomedical Engineering, Quality System, CAPA, V&V, R&D, Cross-functional Team...
Education
The University of Texas Southwestern Medical Center at Dallas 1977 — 1981
Ph.D., Biomedical engineering
Texas A&M University
M.S., Biomedical Engineering