Terumo Cardiovascular Systems
Industry: Company
DescriptionFounded: 1999 Parent organization: Terumo Medical Corporation
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Terumo Cardiovascular Systems Employees
Employee
Years
Job
Industry
Rafael Elias Rafael Elias's Terumo Cardiovascular Systems Experience December 2012 - Present
Job Central Engineering Manager at Terumo Cardiovascular Systems
Industry Biotechnology
Experience
Terumo Cardiovascular Systems December 2012 - Present
Motorola Mobile Devices June 2005 - October 2012
Motorola Mobile Devices January 2000 - June 2005
LifeScan 1999 - 2001
Symmetricom 1986 - 1998
Skills
Computer Hardware, Manufacturing..., Software Testing Life..., Data Analysis, Database Design, Database Administration, Financial Reporting, Quality Reporting, Operating Systems, Microsoft Office, Microsoft Excel, Access Database, MySQL Database, Linux Desktop, Mechanical Aptitude, Regression Testing, Field Training, Independent..., Fully bilingual English, Spanish-speaking, Musicians, Electronics Repair, Electrical..., Telecommunications..., Biomedical Engineering, Management, Staff Supervision, internal audit, Training Delivery, Software Documentation, Technical Documentation, Schematic, Production Support, Technical Presentations, Biodiesel Production, Internal Audit, Six Sigma, V&V, Process Improvement, Cross-functional Team...
Education
University of Puerto Rico - Mayaguez Campus 1975 — 1980
BS, Electrical and Electronics Engineering
University of Puerto Rico-Mayaguez 1975 — 1980
Bachelor of Science (BS), Electrical and Electronics Engineering
Terumo Cardiovascular Systems December 2012 - Present
Motorola Mobile Devices June 2005 - October 2012
Motorola Mobile Devices January 2000 - June 2005
LifeScan 1999 - 2001
Symmetricom 1986 - 1998
Skills
Computer Hardware, Manufacturing..., Software Testing Life..., Data Analysis, Database Design, Database Administration, Financial Reporting, Quality Reporting, Operating Systems, Microsoft Office, Microsoft Excel, Access Database, MySQL Database, Linux Desktop, Mechanical Aptitude, Regression Testing, Field Training, Independent..., Fully bilingual English, Spanish-speaking, Musicians, Electronics Repair, Electrical..., Telecommunications..., Biomedical Engineering, Management, Staff Supervision, internal audit, Training Delivery, Software Documentation, Technical Documentation, Schematic, Production Support, Technical Presentations, Biodiesel Production, Internal Audit, Six Sigma, V&V, Process Improvement, Cross-functional Team...
Education
University of Puerto Rico - Mayaguez Campus 1975 — 1980
BS, Electrical and Electronics Engineering
University of Puerto Rico-Mayaguez 1975 — 1980
Bachelor of Science (BS), Electrical and Electronics Engineering
Chloe Garrage Chloe Garrage's Terumo Cardiovascular Systems Experience May 2015 - Present
Job Engineer I at Terumo Cardiovascular Systems
Industry Mechanical or Industrial Engineering
Experience
Terumo Cardiovascular Systems May 2015 - Present
NSTAR, now Eversource Energy June 2014 - April 2015
IAC Group July 2013 - October 2013
Skills
Matlab, Microsoft Office, Solidworks, Mathematics, Cypress, Manufacturing, CAD, Simulink, Engineering, Process Engineering, Mechanical Engineering
Education
University of New Hampshire 2009 — 2013
Bachelor of Science (BS), Mechanical Engineering, Cum Laude
Terumo Cardiovascular Systems May 2015 - Present
NSTAR, now Eversource Energy June 2014 - April 2015
IAC Group July 2013 - October 2013
Skills
Matlab, Microsoft Office, Solidworks, Mathematics, Cypress, Manufacturing, CAD, Simulink, Engineering, Process Engineering, Mechanical Engineering
Education
University of New Hampshire 2009 — 2013
Bachelor of Science (BS), Mechanical Engineering, Cum Laude
Florence Laverny-Rafter Florence Laverny-Rafter's Terumo Cardiovascular Systems Experience August 2013 - Present
Job Director, Corporate Quality Systems at Terumo Cardiovascular Systems
Industry Medical Devices
Experience
Terumo Cardiovascular Systems August 2013 - Present
Medtronic June 2012 - May 2013
Medtronic February 2007 - June 2012
Baker Tilly Virchow Krause, LLP January 2004 - February 2007
QIAGEN February 2002 - January 2004
Arthur Andersen May 1998 - November 2001
Boehringer Ingelheim January 1994 - August 1996
Skills
FDA, Medical Devices, Quality System, Validation, Quality Strategy, Root Cause Analysis, Quality Auditing, Program Management, Business Process..., V&V, CAPA, Design Control, Quality Control, Change Control, ISO, Cross-functional Team...
Education
University of Minnesota - Carlson School of Management 1996 — 1998
MBA, Operations
European Engineering school of Chemistry, Polymers, and Materials Science (ECPM) 1990 — 1993
Ingenieur chimiste, Grandes Ecoles
Terumo Cardiovascular Systems August 2013 - Present
Medtronic June 2012 - May 2013
Medtronic February 2007 - June 2012
Baker Tilly Virchow Krause, LLP January 2004 - February 2007
QIAGEN February 2002 - January 2004
Arthur Andersen May 1998 - November 2001
Boehringer Ingelheim January 1994 - August 1996
Skills
FDA, Medical Devices, Quality System, Validation, Quality Strategy, Root Cause Analysis, Quality Auditing, Program Management, Business Process..., V&V, CAPA, Design Control, Quality Control, Change Control, ISO, Cross-functional Team...
Education
University of Minnesota - Carlson School of Management 1996 — 1998
MBA, Operations
European Engineering school of Chemistry, Polymers, and Materials Science (ECPM) 1990 — 1993
Ingenieur chimiste, Grandes Ecoles
Jessica Rey's Terumo Cardiovascular Systems Experience May 2015 - Present
Job Program Management Office at Terumo Cardiovascular Systems
Industry Executive Office
Experience
Terumo Cardiovascular Systems May 2015 - Present
Rolls-Royce Power Systems AG (MTU America Division) May 2013 - May 2015
Proctor Financial, Inc June 2012 - May 2013
Skills
Microsoft Word, Microsoft Excel, Microsoft Office, Planning, PowerPoint, Customer Service, Event Planning, Leadership, Process Improvement, Continuous Improvement, Teamwork, Training, Time Management, Project Management, Microsoft SharePoint..., Accomodation/Contract...
Education
University of Michigan-Flint 2011 — 2015
Bachelor of Business Administration (BBA), International Business and Marketing
Terumo Cardiovascular Systems May 2015 - Present
Rolls-Royce Power Systems AG (MTU America Division) May 2013 - May 2015
Proctor Financial, Inc June 2012 - May 2013
Skills
Microsoft Word, Microsoft Excel, Microsoft Office, Planning, PowerPoint, Customer Service, Event Planning, Leadership, Process Improvement, Continuous Improvement, Teamwork, Training, Time Management, Project Management, Microsoft SharePoint..., Accomodation/Contract...
Education
University of Michigan-Flint 2011 — 2015
Bachelor of Business Administration (BBA), International Business and Marketing
Timothy Cassity Timothy Cassity's Terumo Cardiovascular Systems Experience January 2011 - April 2012
Job Supplier Quality Assurance at Philips Heathcare
Industry Medical Devices
Experience
Philips Healthcare October 2014 - Present
Zimmer June 2014 - October 2014
Sparta Systems, Inc. December 2013 - June 2014
Volcano Corporation 2013 - 2014
Hill-Rom May 2013 - October 2013
Synthes April 2013 - May 2013
Zimmer October 2012 - April 2013
Shire Pharmaceuticals June 2012 - October 2012
Terumo Cardiovascular Systems January 2011 - April 2012
Pinnacle Enterprise Group February 2002 - January 2011
Skills
ISO 13485, FDA, CAPA, 21 CFR Part 11, Quality System, V&V, Validation, Medical Devices, Quality Auditing, Change Control, GMP, ISO 14971, Regulatory Affairs, Quality Assurance, Complaint Management, FMEA, Manufacturing, Quality Control, Biotechnology, Auditing, Iso 9000, Six Sigma, Continuous Improvement, Internal Audit, Quality Management, ISO, Root Cause Analysis, ISO 14001, SPC, Design Control, Calibration, TQM, Value Stream Mapping, Testing, Sop, Product Quality, 21 CFR, Corrective Actions, Supplier Quality, Computer System..., DMAIC, GxP, AS9100, Minitab, Cleaning Validation, Regulatory Requirements, GAMP, FDA GMP, ISO 9000
Education
UNIVERSITY OF PHOENIX 1990 — 1992
Total Quality Management -Certificate Program, Quality Management, GPA 3.8
University of New Orleans
Philips Healthcare October 2014 - Present
Zimmer June 2014 - October 2014
Sparta Systems, Inc. December 2013 - June 2014
Volcano Corporation 2013 - 2014
Hill-Rom May 2013 - October 2013
Synthes April 2013 - May 2013
Zimmer October 2012 - April 2013
Shire Pharmaceuticals June 2012 - October 2012
Terumo Cardiovascular Systems January 2011 - April 2012
Pinnacle Enterprise Group February 2002 - January 2011
Skills
ISO 13485, FDA, CAPA, 21 CFR Part 11, Quality System, V&V, Validation, Medical Devices, Quality Auditing, Change Control, GMP, ISO 14971, Regulatory Affairs, Quality Assurance, Complaint Management, FMEA, Manufacturing, Quality Control, Biotechnology, Auditing, Iso 9000, Six Sigma, Continuous Improvement, Internal Audit, Quality Management, ISO, Root Cause Analysis, ISO 14001, SPC, Design Control, Calibration, TQM, Value Stream Mapping, Testing, Sop, Product Quality, 21 CFR, Corrective Actions, Supplier Quality, Computer System..., DMAIC, GxP, AS9100, Minitab, Cleaning Validation, Regulatory Requirements, GAMP, FDA GMP, ISO 9000
Education
UNIVERSITY OF PHOENIX 1990 — 1992
Total Quality Management -Certificate Program, Quality Management, GPA 3.8
University of New Orleans
David A. White David A. White's Terumo Cardiovascular Systems Experience April 2011 - August 2011
Job Contract Design Quality Engineer
Industry Medical Devices
Experience
Takeda Pharmaceuticals January 2015 - May 2015
St. Jude Medical August 2011 - December 2014
Validant April 2011 - August 2011
Terumo Cardiovascular Systems April 2011 - August 2011
Abbott Laboratories 2002 - 2010
Abbott Laboratories 1998 - 2002
Abbott Laboratories 1995 - 1998
Abbott Diagnostics 1984 - 1995
Skills
CAPA, Design Control, FDA, ISO 13485, Quality Assurance, Medical Devices, Risk Management, Quality Management, ISO 14971, Root Cause Analysis, Validation, Process Control, Quality System, R&D, Quality Control, GMP, Design of Experiments, Quality Auditing, V&V, Change Control, FMEA, Manufacturing, 21 CFR, DMAIC, SPC
Education
University of North Texas
Bachelor's degree, Biology, Genetics
Takeda Pharmaceuticals January 2015 - May 2015
St. Jude Medical August 2011 - December 2014
Validant April 2011 - August 2011
Terumo Cardiovascular Systems April 2011 - August 2011
Abbott Laboratories 2002 - 2010
Abbott Laboratories 1998 - 2002
Abbott Laboratories 1995 - 1998
Abbott Diagnostics 1984 - 1995
Skills
CAPA, Design Control, FDA, ISO 13485, Quality Assurance, Medical Devices, Risk Management, Quality Management, ISO 14971, Root Cause Analysis, Validation, Process Control, Quality System, R&D, Quality Control, GMP, Design of Experiments, Quality Auditing, V&V, Change Control, FMEA, Manufacturing, 21 CFR, DMAIC, SPC
Education
University of North Texas
Bachelor's degree, Biology, Genetics
Garrett Mecca Garrett Mecca's Terumo Cardiovascular Systems Experience January 2009 - May 2009
Job Network Administrator at Rogue Community College
Industry Information Technology and Services
Experience
Rogue Community College September 2011 - Present
Fast Server LLC September 2010 - September 2011
TEKsystems November 2009 - November 2009
Terumo Cardiovascular Systems January 2009 - May 2009
Toyota Material Handling September 2007 - January 2009
Toyota Material Handling, U.S.A., Inc. 2007 - 2009
Professional Resume Assistance June 2007 - July 2008
Impac Mortgage Holdings April 2007 - September 2007
Lamont Electrical Construction November 2006 - April 2007
United Communications April 2005 - November 2006
Skills
Troubleshooting, Technical Support, Training, Telecommunications, SAP, Networking, System Administration, Network Administration, Help Desk Support, Process Improvement, Vendor Management, Project Management, Integration, Computer Hardware
Education
University of Portland 1998 — 2002
BS, Electrical Engineering
Rogue Community College September 2011 - Present
Fast Server LLC September 2010 - September 2011
TEKsystems November 2009 - November 2009
Terumo Cardiovascular Systems January 2009 - May 2009
Toyota Material Handling September 2007 - January 2009
Toyota Material Handling, U.S.A., Inc. 2007 - 2009
Professional Resume Assistance June 2007 - July 2008
Impac Mortgage Holdings April 2007 - September 2007
Lamont Electrical Construction November 2006 - April 2007
United Communications April 2005 - November 2006
Skills
Troubleshooting, Technical Support, Training, Telecommunications, SAP, Networking, System Administration, Network Administration, Help Desk Support, Process Improvement, Vendor Management, Project Management, Integration, Computer Hardware
Education
University of Portland 1998 — 2002
BS, Electrical Engineering
Crystal Fuller Crystal Fuller's Terumo Cardiovascular Systems Experience July 2013 - Present
Job Business Analyst at Terumo Cardiovascular Systems
Industry Medical Devices
Experience
Terumo Cardiovascular Systems July 2013 - Present
Terumo Cardiovascular Systems November 2010 - July 2013
Terumo Cardiovascular Systems February 2009 - October 2010
Terumo Cardiovascular Systems May 2007 - February 2009
Independent Bank June 2002 - May 2007
Skills
Process Improvement, Crystal Reports, Business Objects, Business Analysis, SQL, Microsoft Excel, Payroll, Quality System, Software Documentation, Microsoft Office, Training, Analysis, Human Resources, Microsoft SQL Server, Quality Assurance
Education
University of Michigan-Flint 2001 — 2005
BBA, Marketing
Terumo Cardiovascular Systems July 2013 - Present
Terumo Cardiovascular Systems November 2010 - July 2013
Terumo Cardiovascular Systems February 2009 - October 2010
Terumo Cardiovascular Systems May 2007 - February 2009
Independent Bank June 2002 - May 2007
Skills
Process Improvement, Crystal Reports, Business Objects, Business Analysis, SQL, Microsoft Excel, Payroll, Quality System, Software Documentation, Microsoft Office, Training, Analysis, Human Resources, Microsoft SQL Server, Quality Assurance
Education
University of Michigan-Flint 2001 — 2005
BBA, Marketing
Jackie Jackson Jackie Jackson's Terumo Cardiovascular Systems Experience February 2011 - March 2014
Job Operations Buyer at Destaco
Industry Industrial Automation
Experience
Destaco - Industrial Product Group December 2014 - Present
Terumo Cardiovascular Systems February 2011 - March 2014
Inergy Automotive Systems May 2004 - July 2010
General Motors January 1998 - January 2004
Vehma International February 1996 - March 1998
Skills
Lean Manufacturing, Automotive, Continuous Improvement, FMEA, Process Improvement, Six Sigma, Root Cause Analysis, Manufacturing, Kaizen, PPAP, Value Stream Mapping
Education
University of Phoenix 2009 — 2011
BS, Intergrated Supply Chain Operations and Management
Wayne Community College
Business Administration
Destaco - Industrial Product Group December 2014 - Present
Terumo Cardiovascular Systems February 2011 - March 2014
Inergy Automotive Systems May 2004 - July 2010
General Motors January 1998 - January 2004
Vehma International February 1996 - March 1998
Skills
Lean Manufacturing, Automotive, Continuous Improvement, FMEA, Process Improvement, Six Sigma, Root Cause Analysis, Manufacturing, Kaizen, PPAP, Value Stream Mapping
Education
University of Phoenix 2009 — 2011
BS, Intergrated Supply Chain Operations and Management
Wayne Community College
Business Administration
Carpenter Jeff Carpenter Jeff's Terumo Cardiovascular Systems Experience ATS MEDICALATS Medical, Inc.1900 - 1900
Job Senior Territory Manager at Terumo Cardiovascular Systems
Industry Medical Devices
Experience
Terumo Cardiovascular Systems ATS MEDICALATS Medical, Inc.1900 - 1900
Skills
Medical Devices, Operating Room, Product Launch, Cardiac Surgery, Capital Equipment, Surgery, Hospitals, Healthcare
Education
University of Missouri-Columbia, College of Business 1976 — 1980
Terumo Cardiovascular Systems ATS MEDICALATS Medical, Inc.1900 - 1900
Skills
Medical Devices, Operating Room, Product Launch, Cardiac Surgery, Capital Equipment, Surgery, Hospitals, Healthcare
Education
University of Missouri-Columbia, College of Business 1976 — 1980
Doug Hewitt Doug Hewitt's Terumo Cardiovascular Systems Experience 2011 - 2014
Job Technical Writer and Editor
Industry Writing and Editing
Experience
Terumo Cardiovascular Systems 2011 - 2014
home January 1990 - July 2011
Gilbarco Inc January 1989 - July 2011
Gilbarco Veeder Root January 1984 - January 1989
Skills
Technical Writing, Publications, Software Documentation, Freelance Writing, Editing, Writing
Education
University of North Carolina at Greensboro 1995 — 1999
M.A., Liberal Studies
University of North Carolina at Greensboro
B.S, Mathematics
Terumo Cardiovascular Systems 2011 - 2014
home January 1990 - July 2011
Gilbarco Inc January 1989 - July 2011
Gilbarco Veeder Root January 1984 - January 1989
Skills
Technical Writing, Publications, Software Documentation, Freelance Writing, Editing, Writing
Education
University of North Carolina at Greensboro 1995 — 1999
M.A., Liberal Studies
University of North Carolina at Greensboro
B.S, Mathematics
Razi Jafri's Terumo Cardiovascular Systems Experience July 2011 - April 2012
Job Co Founder at NeighborFix
Industry Medical Devices
Experience
NeighborFix February 2015 - Present
Xoran Technologies May 2012 - May 2015
Terumo Cardiovascular Systems July 2011 - April 2012
Terumo Cardiovascular Systems January 2011 - July 2011
Yazaki North America May 2010 - January 2011
Yazaki North America January 2006 - May 2010
Skills
Root Cause Analysis, CAPA, ISO 13485, Quality Control, Product Design, Quality Assurance, Product Development, Catia, PowerPoint, Industrial Engineering, FDA GMP, CAD, Microsoft Office, Visio, 8D Problem Solving, 5S, 21 CFR 820, Six Sigma, Microsoft Word, Pro Engineer, I-DEAS, FDA, Project Management, Team Management, Team Building, Team Leadership, Cross-functional Team..., Design, Photography, Creativity Skills, Innovation Development, Focus Groups, Design Engineering, Product Management
Education
University of Michigan-Dearborn 2000 — 2005
Bachelors of Science, Manufacturing Engineering
NeighborFix February 2015 - Present
Xoran Technologies May 2012 - May 2015
Terumo Cardiovascular Systems July 2011 - April 2012
Terumo Cardiovascular Systems January 2011 - July 2011
Yazaki North America May 2010 - January 2011
Yazaki North America January 2006 - May 2010
Skills
Root Cause Analysis, CAPA, ISO 13485, Quality Control, Product Design, Quality Assurance, Product Development, Catia, PowerPoint, Industrial Engineering, FDA GMP, CAD, Microsoft Office, Visio, 8D Problem Solving, 5S, 21 CFR 820, Six Sigma, Microsoft Word, Pro Engineer, I-DEAS, FDA, Project Management, Team Management, Team Building, Team Leadership, Cross-functional Team..., Design, Photography, Creativity Skills, Innovation Development, Focus Groups, Design Engineering, Product Management
Education
University of Michigan-Dearborn 2000 — 2005
Bachelors of Science, Manufacturing Engineering
Andrew Endahl Andrew Endahl's Terumo Cardiovascular Systems Experience October 2011 - March 2015
Job Consultant at Medical Device Regulatory Solutions (MDRS,LLC)
Industry Medical Devices
Experience
Medical Device Regulatory Solutions (MDRS,LLC) June 2015 - Present
Terumo Cardiovascular Systems October 2011 - March 2015
TelCare June 2011 - August 2011
Hakki Medical Technologies Inc. December 2009 - June 2011
University of Central Florida August 2008 - November 2009
Ela Medical January 2000 - February 2008
Ideas for Medicine, Inc. March 1993 - January 2000
Skills
Medical Devices, CAPA, ISO 13485, Quality Assurance, Quality System, Process Improvement, Root Cause Analysis, Quality Management, Biomedical Engineering, Manufacturing, R&D, Engineering, FDA, Design Control, Validation, Manufacturing..., V&V, FMEA, Design of Experiments, ISO 14971, Minitab
Education
University of South Florida 1985 — 1992
BSEE, Electrical Engineering
University of South Florida
MSBE, Biomedical Engineering
Medical Device Regulatory Solutions (MDRS,LLC) June 2015 - Present
Terumo Cardiovascular Systems October 2011 - March 2015
TelCare June 2011 - August 2011
Hakki Medical Technologies Inc. December 2009 - June 2011
University of Central Florida August 2008 - November 2009
Ela Medical January 2000 - February 2008
Ideas for Medicine, Inc. March 1993 - January 2000
Skills
Medical Devices, CAPA, ISO 13485, Quality Assurance, Quality System, Process Improvement, Root Cause Analysis, Quality Management, Biomedical Engineering, Manufacturing, R&D, Engineering, FDA, Design Control, Validation, Manufacturing..., V&V, FMEA, Design of Experiments, ISO 14971, Minitab
Education
University of South Florida 1985 — 1992
BSEE, Electrical Engineering
University of South Florida
MSBE, Biomedical Engineering
Danielle Wittbrodt Danielle Wittbrodt's Terumo Cardiovascular Systems Experience June 2015 - Present
Job Engineer at Terumo Cardiovascular
Industry Biotechnology
Experience
Terumo Cardiovascular Systems June 2015 - Present
Terumo Cardiovascular Systems October 2014 - June 2015
LandArc July 2014 - October 2014
Genentech August 2013 - June 2014
The Elbow Room July 2009 - August 2013
University of Michigan-Flint September 2012 - January 2013
University of Michigan-Flint August 2008 - December 2012
The City of Flushing July 2006 - August 2011
Skills
Laboratory Skills, Molecular Biology, Biochemistry, Western Blotting, Gel Electrophoresis, Research Experience, Chemistry, Report Writing, PCR, Mammalian Cell Culture, Trackwise, FDA GMP, Emerson DeltaV, Critical Thinking, Data Analysis, Public Speaking, PowerPoint, Microsoft Word, Community Outreach, Microsoft Office, Microsoft Excel, Customer Service, Sop, Research, SOP
Education
University of Michigan-Flint 2008 — 2012
Bachelor of Science (B.S.), Molecular Biology and Biotechnology
Terumo Cardiovascular Systems June 2015 - Present
Terumo Cardiovascular Systems October 2014 - June 2015
LandArc July 2014 - October 2014
Genentech August 2013 - June 2014
The Elbow Room July 2009 - August 2013
University of Michigan-Flint September 2012 - January 2013
University of Michigan-Flint August 2008 - December 2012
The City of Flushing July 2006 - August 2011
Skills
Laboratory Skills, Molecular Biology, Biochemistry, Western Blotting, Gel Electrophoresis, Research Experience, Chemistry, Report Writing, PCR, Mammalian Cell Culture, Trackwise, FDA GMP, Emerson DeltaV, Critical Thinking, Data Analysis, Public Speaking, PowerPoint, Microsoft Word, Community Outreach, Microsoft Office, Microsoft Excel, Customer Service, Sop, Research, SOP
Education
University of Michigan-Flint 2008 — 2012
Bachelor of Science (B.S.), Molecular Biology and Biotechnology
Thomas Danowski Jr Thomas Danowski Jr's Terumo Cardiovascular Systems Experience June 2014 - Present
Job Engineer II Product Subject Matter Expert at Terumo Cardiovascular Systems
Industry Mechanical or Industrial Engineering
Experience
Terumo Cardiovascular Systems June 2014 - Present
Terumo Cardiovascular Systems March 2013 - June 2014
Terumo Cardiovascular Systems October 2010 - March 2013
Professional Educational Services Group LLC October 2009 - October 2010
University of Michigan Dearborn January 2004 - April 2008
Associated Spring Barnes Group August 2005 - August 2007
Skills
Finite Element Analysis, Pro Engineer, GD&T, CAD, Catia, Machining, Heat Transfer, FMEA, Lean Manufacturing, Manufacturing, Failure Analysis, CAPA, Ideas NX, Product Complaints, FDA GMP, FDA, Mechanical Engineering, Solidworks, Health Hazard..., Recalls, GDP, Microsoft Office, Unix, ISO 13485, Medical Devices, Design of Experiments, Minitab, Continuous Improvement, Root Cause Analysis, SolidWorks, Geometric Dimensioning...
Education
University of Michigan-Dearborn 2003 — 2008
Bachelors of Science Engineering, Mechanical Engineering
Terumo Cardiovascular Systems June 2014 - Present
Terumo Cardiovascular Systems March 2013 - June 2014
Terumo Cardiovascular Systems October 2010 - March 2013
Professional Educational Services Group LLC October 2009 - October 2010
University of Michigan Dearborn January 2004 - April 2008
Associated Spring Barnes Group August 2005 - August 2007
Skills
Finite Element Analysis, Pro Engineer, GD&T, CAD, Catia, Machining, Heat Transfer, FMEA, Lean Manufacturing, Manufacturing, Failure Analysis, CAPA, Ideas NX, Product Complaints, FDA GMP, FDA, Mechanical Engineering, Solidworks, Health Hazard..., Recalls, GDP, Microsoft Office, Unix, ISO 13485, Medical Devices, Design of Experiments, Minitab, Continuous Improvement, Root Cause Analysis, SolidWorks, Geometric Dimensioning...
Education
University of Michigan-Dearborn 2003 — 2008
Bachelors of Science Engineering, Mechanical Engineering
Tom Silka's Terumo Cardiovascular Systems Experience July 2008 - March 2012
Job Manufacturing Engineer at Delphinus Medical Technologies, Inc.
Industry Medical Devices
Experience
Delphinus Medical Technologies, Inc. April 2014 - Present
Delphinus Medical Technologies, Inc. March 2012 - September 2014
Terumo Cardiovascular Systems July 2008 - March 2012
Terumo Cardiovascular Systems May 2007 - July 2008
Oakwood Healthcare October 2006 - May 2007
Fresenius Medical Care July 2002 - October 2006
Skills
ISO 13485, ISO 14971, FDA, Medical Devices, Product Development, Quality Systems, Quality Assurance, Validation, Risk Management, Hazard Analysis, FMEA, Quality System, Design Control, Product Launch, V&V, 21 CFR Part 11, CAPA, GMP
Education
Wayne State University 2009 — 2011
Masters of Science (M.S.), Biomedical Engineering
University of Michigan-Dearborn 2002 — 2007
Bachelors of Science in Engineering (B.S.E.), Mechanical Engineering
Delphinus Medical Technologies, Inc. April 2014 - Present
Delphinus Medical Technologies, Inc. March 2012 - September 2014
Terumo Cardiovascular Systems July 2008 - March 2012
Terumo Cardiovascular Systems May 2007 - July 2008
Oakwood Healthcare October 2006 - May 2007
Fresenius Medical Care July 2002 - October 2006
Skills
ISO 13485, ISO 14971, FDA, Medical Devices, Product Development, Quality Systems, Quality Assurance, Validation, Risk Management, Hazard Analysis, FMEA, Quality System, Design Control, Product Launch, V&V, 21 CFR Part 11, CAPA, GMP
Education
Wayne State University 2009 — 2011
Masters of Science (M.S.), Biomedical Engineering
University of Michigan-Dearborn 2002 — 2007
Bachelors of Science in Engineering (B.S.E.), Mechanical Engineering
Elizabeth (Klimek) Perez's Terumo Cardiovascular Systems Experience October 2004 - November 2006
Job Scientist
Industry Research
Experience
Roche Molecular Systems November 2009 - August 2015
Planet Biotechnology Inc. December 2008 - September 2009
University of Michigan November 2006 - November 2008
Terumo Cardiovascular Systems October 2004 - November 2006
Skills
PCR, Biotechnology, Molecular Biology, FDA, ELISA, Medical Devices, Cell, Western Blotting, Biochemistry, Protein Chemistry, SDS-PAGE, RT-PCR, Protein Expression, Laboratory, DNA, Assay Development
Education
University of Notre Dame 2000 — 2004
BS, Biochemistry
Roche Molecular Systems November 2009 - August 2015
Planet Biotechnology Inc. December 2008 - September 2009
University of Michigan November 2006 - November 2008
Terumo Cardiovascular Systems October 2004 - November 2006
Skills
PCR, Biotechnology, Molecular Biology, FDA, ELISA, Medical Devices, Cell, Western Blotting, Biochemistry, Protein Chemistry, SDS-PAGE, RT-PCR, Protein Expression, Laboratory, DNA, Assay Development
Education
University of Notre Dame 2000 — 2004
BS, Biochemistry
Dale Schak's Terumo Cardiovascular Systems Experience January 2013 - July 2013
Job Manufacturing Engineer at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical August 2014 - Present
Covidien August 2013 - July 2014
Terumo Cardiovascular Systems January 2013 - July 2013
Apnex Medical, Inc. June 2012 - September 2012
American Medical Systems November 2011 - June 2012
Apnex Medical, Inc. January 2011 - November 2011
Olympus Medical (Fomerly Gyrus ACMI Medical) November 2008 - March 2010
Medtronic September 1997 - October 2005
Skills
Medical Devices, FDA, ISO 13485, Biomedical Engineering, Design Control, Lean Manufacturing, Validation, R&D, Solidworks, Product Development, V&V, Design of Experiments, Design for Manufacturing, CAPA, Manufacturing, Quality System, FMEA, Manufacturing..., Process Simulation, SPC, Product Launch, Root Cause Analysis, GMP, ISO, Quality Control, Minitab, Cross-functional Team..., Product Design
Education
University of Minnesota-Twin Cities 1994 — 1998
B.S., Mat Sci
St. Jude Medical August 2014 - Present
Covidien August 2013 - July 2014
Terumo Cardiovascular Systems January 2013 - July 2013
Apnex Medical, Inc. June 2012 - September 2012
American Medical Systems November 2011 - June 2012
Apnex Medical, Inc. January 2011 - November 2011
Olympus Medical (Fomerly Gyrus ACMI Medical) November 2008 - March 2010
Medtronic September 1997 - October 2005
Skills
Medical Devices, FDA, ISO 13485, Biomedical Engineering, Design Control, Lean Manufacturing, Validation, R&D, Solidworks, Product Development, V&V, Design of Experiments, Design for Manufacturing, CAPA, Manufacturing, Quality System, FMEA, Manufacturing..., Process Simulation, SPC, Product Launch, Root Cause Analysis, GMP, ISO, Quality Control, Minitab, Cross-functional Team..., Product Design
Education
University of Minnesota-Twin Cities 1994 — 1998
B.S., Mat Sci
Amy Gebers's Terumo Cardiovascular Systems Experience 2008 - Present
Job Clinical Specialist Terumo CVS
Industry Medical Practice
Experience
Terumo Cardiovascular Systems 2008 - Present
Kaiser Permanente October 2010 - April 2013
Vail Valley Medical Center November 2007 - November 2012
Skills
Surgery, Hospitals, Medical Devices, Operating Room, Healthcare, Orthopedic, Vascular, Capital Equipment, General Surgery, Interventional Radiology, Neurosurgery, Spine, Interventional..., Vascular Surgery, Cardiac Surgery, Surgeons, Surgical Instruments, Disposables, Cardiothoracic Surgery, Cath Lab, Endoscopy, Cardiology
Education
The University of Montana
Health Science
Western Iowa Tech Community College
Terumo Cardiovascular Systems 2008 - Present
Kaiser Permanente October 2010 - April 2013
Vail Valley Medical Center November 2007 - November 2012
Skills
Surgery, Hospitals, Medical Devices, Operating Room, Healthcare, Orthopedic, Vascular, Capital Equipment, General Surgery, Interventional Radiology, Neurosurgery, Spine, Interventional..., Vascular Surgery, Cardiac Surgery, Surgeons, Surgical Instruments, Disposables, Cardiothoracic Surgery, Cath Lab, Endoscopy, Cardiology
Education
The University of Montana
Health Science
Western Iowa Tech Community College
Chip Wertenberger's Terumo Cardiovascular Systems Experience May 2014 - Present
Job Now working as Sr. Design Quality Engineer at Terumo Cardiovascular in Ann Arbor MI
Industry Medical Devices
Experience
Terumo Cardiovascular Systems May 2014 - Present
REVA Medical, Inc. July 2013 - March 2014
Vesta Thermoplastics January 2012 - July 2013
Consulting Company January 2007 - October 2010
Hospira January 1999 - January 2007
Abbott Laboratories December 1996 - January 1999
Skills
Calibration, Quality System, FDA, Project Management, Validation, Metrology, Preventive Maintenance, Medical Devices, Manufacturing, Testing, Quality Assurance, Lean Manufacturing, Six Sigma, Process Engineering, Engineering, Software Documentation, Manufacturing..., Continuous Improvement, Process Improvement, ISO 13485, FMEA, V&V, CAPA, R&D, ISO 14971, 21 CFR Part 11, Sop, Change Control, GxP, Iso 9000, Root Cause Analysis, Computer System..., GMP, GLP, Quality Control, Supplier Quality, Quality Auditing, Quality Management, Process Simulation, DMAIC, Software Quality..., SPC, SDLC, Minitab, Design of Experiments, Design Control, Cross-functional Team..., Regulatory Affairs, 21 CFR, ISO
Education
University of Phoenix 2009 — 2010
MBA, Business
University of Phoenix 2001 — 2007
BSIT, Information Technology
Terumo Cardiovascular Systems May 2014 - Present
REVA Medical, Inc. July 2013 - March 2014
Vesta Thermoplastics January 2012 - July 2013
Consulting Company January 2007 - October 2010
Hospira January 1999 - January 2007
Abbott Laboratories December 1996 - January 1999
Skills
Calibration, Quality System, FDA, Project Management, Validation, Metrology, Preventive Maintenance, Medical Devices, Manufacturing, Testing, Quality Assurance, Lean Manufacturing, Six Sigma, Process Engineering, Engineering, Software Documentation, Manufacturing..., Continuous Improvement, Process Improvement, ISO 13485, FMEA, V&V, CAPA, R&D, ISO 14971, 21 CFR Part 11, Sop, Change Control, GxP, Iso 9000, Root Cause Analysis, Computer System..., GMP, GLP, Quality Control, Supplier Quality, Quality Auditing, Quality Management, Process Simulation, DMAIC, Software Quality..., SPC, SDLC, Minitab, Design of Experiments, Design Control, Cross-functional Team..., Regulatory Affairs, 21 CFR, ISO
Education
University of Phoenix 2009 — 2010
MBA, Business
University of Phoenix 2001 — 2007
BSIT, Information Technology
Jeff Hanna's Terumo Cardiovascular Systems Experience 2011 - Present
Job Product Manager at Terumo Cardiovascular Systems
Industry Medical Devices
Experience
Terumo Cardiovascular Systems 2011 - Present
terumo cardiovascular systems February 2007 - 2011
Terumo Cardiovascular Systems March 2000 - February 2007
Perceptron March 1996 - March 1999
Murray's Car Audio June 1992 - February 1995
Skills
Product Development, Microsoft Office, Product Management, Medical Devices, Product Launch, Disposables, Pricing Strategy, Product Marketing, Product Launches, Capital Equipment, FDA, Product Design, Market Analysis, Cardiology, Market Research, Segmentation, Marketing Strategy, Quality Systems, Biomedical Engineering, Quality System, Design Control, ISO 13485
Education
University of Phoenix 2008 — 2012
BSB/MKT, Business Management/Marketing
Terumo Cardiovascular Systems 2011 - Present
terumo cardiovascular systems February 2007 - 2011
Terumo Cardiovascular Systems March 2000 - February 2007
Perceptron March 1996 - March 1999
Murray's Car Audio June 1992 - February 1995
Skills
Product Development, Microsoft Office, Product Management, Medical Devices, Product Launch, Disposables, Pricing Strategy, Product Marketing, Product Launches, Capital Equipment, FDA, Product Design, Market Analysis, Cardiology, Market Research, Segmentation, Marketing Strategy, Quality Systems, Biomedical Engineering, Quality System, Design Control, ISO 13485
Education
University of Phoenix 2008 — 2012
BSB/MKT, Business Management/Marketing
Andrew Kwasnieski's Terumo Cardiovascular Systems Experience December 2009 - Present
Job at Terumo Cardiovascular Systems
Industry Medical Devices
Experience
Terumo Cardiovascular Systems December 2009 - Present
Ventana Medical Systems April 2008 - April 2010
Mallinckrodt July 2006 - April 2008
Bristol-Myers Squibb Medical Imaging October 2004 - July 2006
Tiffany 2002 - 2004
Skills
Cardiology, Capital Equipment, Market Development, Radiology, Pharmaceutical Sales, Hospitals, Sales Management, Cardiac Surgery, Disposables, Managed Care, Product Development, Medical Devices, Physicians, Sales Operations, Product Launch
Education
University of Pittsburgh 1993 — 1998
B.S., Chemistry
Terumo Cardiovascular Systems December 2009 - Present
Ventana Medical Systems April 2008 - April 2010
Mallinckrodt July 2006 - April 2008
Bristol-Myers Squibb Medical Imaging October 2004 - July 2006
Tiffany 2002 - 2004
Skills
Cardiology, Capital Equipment, Market Development, Radiology, Pharmaceutical Sales, Hospitals, Sales Management, Cardiac Surgery, Disposables, Managed Care, Product Development, Medical Devices, Physicians, Sales Operations, Product Launch
Education
University of Pittsburgh 1993 — 1998
B.S., Chemistry
Christopher Pugh's Terumo Cardiovascular Systems Experience August 2010 - January 2012
Job Philips Medical Systems (Cleveland), Inc at Philips Medical
Industry Medical Devices
Experience
Philips Medical September 2014 - Present
Philips Medical Systems (Cleveland), Inc. January 2012 - Present
Terumo Cardiovascular Systems August 2010 - January 2012
Jabil August 1996 - August 2010
Skills
ISO 13485, CAPA, Medical Devices, Supplier Quality, Quality System, FDA, Design Control, V&V, Change Control, ISO 14971, 21 CFR Part 11, Quality Management, Quality Control, Root Cause Analysis, Cross-functional Team..., Continuous Improvement, Document Management, Six Sigma, ISO 14001, ISO, Quality Assurance, Process Improvement, GMP, Value Stream Mapping, Manufacturing..., TS16949, SPC, Validation, Auditing, Iso 9000, DMAIC, Manufacturing, 5S, Calibration, Product Quality, Quality Auditing, FMEA, Kaizen, Sop, Lean Manufacturing, ISO 9000
Education
University of Michigan-Flint
BA, Economics, Political Science
Philips Medical September 2014 - Present
Philips Medical Systems (Cleveland), Inc. January 2012 - Present
Terumo Cardiovascular Systems August 2010 - January 2012
Jabil August 1996 - August 2010
Skills
ISO 13485, CAPA, Medical Devices, Supplier Quality, Quality System, FDA, Design Control, V&V, Change Control, ISO 14971, 21 CFR Part 11, Quality Management, Quality Control, Root Cause Analysis, Cross-functional Team..., Continuous Improvement, Document Management, Six Sigma, ISO 14001, ISO, Quality Assurance, Process Improvement, GMP, Value Stream Mapping, Manufacturing..., TS16949, SPC, Validation, Auditing, Iso 9000, DMAIC, Manufacturing, 5S, Calibration, Product Quality, Quality Auditing, FMEA, Kaizen, Sop, Lean Manufacturing, ISO 9000
Education
University of Michigan-Flint
BA, Economics, Political Science
Brandon Clary's Terumo Cardiovascular Systems Experience March 2008 - March 2013
Job Executive TeamCEO Elbert Memorial HospitalAssistant Vice President of Affiliated Services at AnMed Health
Industry Hospital & Health Care
Experience
AnMed Health January 2015 - Present
Edgefield County Hospital April 2013 - December 2014
Terumo Cardiovascular Systems March 2008 - March 2013
Skills
Surgeons, Medical Devices, Operating Room, Market Development, Surgery, Orthopedics, Leadership, Hospital Operations, Hospitals, Healthcare, Healthcare Management, Sales Operations, Healthcare Information..., Product Launch, Sales, Strategic Planning
Education
Medical University of South Carolina 2014 — 2017
MHA
University of South Carolina - The Moore School of Business 1995 — 2000
Management/Marketing
University of South Carolina-Columbia 1995 — 2000
TL Hanna High School
AnMed Health January 2015 - Present
Edgefield County Hospital April 2013 - December 2014
Terumo Cardiovascular Systems March 2008 - March 2013
Skills
Surgeons, Medical Devices, Operating Room, Market Development, Surgery, Orthopedics, Leadership, Hospital Operations, Hospitals, Healthcare, Healthcare Management, Sales Operations, Healthcare Information..., Product Launch, Sales, Strategic Planning
Education
Medical University of South Carolina 2014 — 2017
MHA
University of South Carolina - The Moore School of Business 1995 — 2000
Management/Marketing
University of South Carolina-Columbia 1995 — 2000
TL Hanna High School
Thomas Baranowski Jr.'s Terumo Cardiovascular Systems Experience November 2003 - Present
Job Senior Clinical Specialist at Terumo Cardiovascular Systems
Industry Medical Devices
Experience
Terumo Cardiovascular Systems November 2003 - Present
Quest Medical August 1996 - August 2003
Emory University May 1984 - August 1993
Skills
Clinical Support, Medical Devices, Cardiac Surgery, Vascular, Biomedical Engineering, Capital Equipment, Cardiology, Clinical Research, Disposables, FDA, Interventional..., Operating Room, Orthopedic, Product Launch, Surgeons, Surgery, Surgical Instruments
Education
University of Pennsylvania 1973 — 1983
Ph.D., Bioengineering
Terumo Cardiovascular Systems November 2003 - Present
Quest Medical August 1996 - August 2003
Emory University May 1984 - August 1993
Skills
Clinical Support, Medical Devices, Cardiac Surgery, Vascular, Biomedical Engineering, Capital Equipment, Cardiology, Clinical Research, Disposables, FDA, Interventional..., Operating Room, Orthopedic, Product Launch, Surgeons, Surgery, Surgical Instruments
Education
University of Pennsylvania 1973 — 1983
Ph.D., Bioengineering
Georgia Eierman's Terumo Cardiovascular Systems Experience December 2012 - December 2013
Job Technical Writing/Business Analysis Consultant
Industry Medical Devices
Experience
Zimmer February 2015 - Present
Zimmer October 2014 - February 2015
DePuy Orthopaedics December 2013 - September 2014
Terumo Cardiovascular Systems December 2012 - December 2013
Elkhart Products, Corporation August 2012 - December 2012
DePuy Orthopaedics June 2011 - December 2011
Zimmer April 2007 - February 2011
Monaco Coach Corporation June 2003 - April 2007
Zimmer April 2002 - February 2003
Bodkin Abstract & Tile Company June 2001 - April 2002
Skills
Business Analysis, Strategic Planning, Business Development, Analysis, Software Documentation, Training, Project Management, Manufacturing, Cross-functional Team..., Process Improvement, Databases, Quality Assurance, Technical Writing, SharePoint, Management Consulting, Integration, Project Planning, Program Management, SDLC, Business Process...
Education
University of Michigan-Flint
Bachelor of Arts, Social Sciences/Communication
Zimmer February 2015 - Present
Zimmer October 2014 - February 2015
DePuy Orthopaedics December 2013 - September 2014
Terumo Cardiovascular Systems December 2012 - December 2013
Elkhart Products, Corporation August 2012 - December 2012
DePuy Orthopaedics June 2011 - December 2011
Zimmer April 2007 - February 2011
Monaco Coach Corporation June 2003 - April 2007
Zimmer April 2002 - February 2003
Bodkin Abstract & Tile Company June 2001 - April 2002
Skills
Business Analysis, Strategic Planning, Business Development, Analysis, Software Documentation, Training, Project Management, Manufacturing, Cross-functional Team..., Process Improvement, Databases, Quality Assurance, Technical Writing, SharePoint, Management Consulting, Integration, Project Planning, Program Management, SDLC, Business Process...
Education
University of Michigan-Flint
Bachelor of Arts, Social Sciences/Communication
Robert Dick's Terumo Cardiovascular Systems Experience 2011 - 2013
Job Risk Management, Design Control, Production and Process Control SME at Validant
Industry Medical Devices
Experience
Advanced Sterilization Products September 2013 - January 2015
Validant August 2011 - August 2013
Terumo Cardiovascular Systems 2011 - 2013
CareFusion May 2007 - October 2010
Viasys HealthCare2003 May 2003 - 2007
Newport Medical Instruments, Inc January 1995 - January 2002
Bear Medical Systems, Inc January 1992 - January 1995
Alcon/Coopervision/Cilco January 1985 - January 1992
Skills
CAPA, FDA, Quality Systems, Validation, Quality Assurance, Design Control, Risk Management, ISO 13485, ISO 14971, ISO 14001, ISO 27001, 21 CFR Part 11, ISO 17025, V&V, Gage R&R, Test Method Validation, GMP, DMAIC, Lean Manufacturing, Root Cause Analysis, Consent Decree
Education
Cal State University, Long Beach
BSEE, Biomedical/Clinical
University of Phoenix
MBA, Technology Management
Advanced Sterilization Products September 2013 - January 2015
Validant August 2011 - August 2013
Terumo Cardiovascular Systems 2011 - 2013
CareFusion May 2007 - October 2010
Viasys HealthCare2003 May 2003 - 2007
Newport Medical Instruments, Inc January 1995 - January 2002
Bear Medical Systems, Inc January 1992 - January 1995
Alcon/Coopervision/Cilco January 1985 - January 1992
Skills
CAPA, FDA, Quality Systems, Validation, Quality Assurance, Design Control, Risk Management, ISO 13485, ISO 14971, ISO 14001, ISO 27001, 21 CFR Part 11, ISO 17025, V&V, Gage R&R, Test Method Validation, GMP, DMAIC, Lean Manufacturing, Root Cause Analysis, Consent Decree
Education
Cal State University, Long Beach
BSEE, Biomedical/Clinical
University of Phoenix
MBA, Technology Management
Nitin Gulati's Terumo Cardiovascular Systems Experience February 2010 - Present
Job Quality Engineer II at Terumo Cardiovascular Systems
Industry Medical Devices
Experience
Terumo Cardiovascular Systems February 2010 - Present
Skills
Solidworks, Project Management, Pro Engineer, Quality Assurance, Failure Analysis, Continuous Improvement, Manufacturing, Testing, Process Improvement, Troubleshooting, ISO 13485, Quality System, Root Cause Analysis
Education
University of Nevada-Reno 2003 — 2008
Bachelors of Science, Mechanical Engineer
Terumo Cardiovascular Systems February 2010 - Present
Skills
Solidworks, Project Management, Pro Engineer, Quality Assurance, Failure Analysis, Continuous Improvement, Manufacturing, Testing, Process Improvement, Troubleshooting, ISO 13485, Quality System, Root Cause Analysis
Education
University of Nevada-Reno 2003 — 2008
Bachelors of Science, Mechanical Engineer
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY