Terumo Heart, Inc
Industry: Company
DescriptionFounded: 2003 Parent organization: Terumo CorporationFeedbackDisclaimer Claim this knowledge panel Knowledge ResultSee outside Moved, closed, or was never hereReportTerumo Heart IncWebsiteDirections Saved (0) Saved Save Manufacturer in Washtenaw County, Michigan Address: 6190 Jackson Rd, Ann Arbor, MI 48103 Phone: (800) 262-3304: Website: Hours: : : Category: : Place name: : : Website: http://www.terumomedical.com/ Category: Manufacturer Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo. · Own this business?Add missing informationAdd business hours Unable to add this file. Please check that it is a valid photo. Questions & answers Ask a questionBe the first to ask a question Add a photoThanks for sharing!Your photo will be posted publicly on Google.Contribute MoreDoneUpload public photos of Terumo Heart Inc Posting publicly on the Web Write a review Reviews Be the first to review
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Terumo Heart, Inc Employees
Employee
Years
Job
Industry
Walid Yasin Walid Yasin's Terumo Heart, Inc Experience 2012 - 2013
Job Sr. Engineering Consultant in Aviation & Aerospace
Industry Aviation & Aerospace
Experience
Aerospace/Aviation Consulting 2013 - Present
Terumo Heart Inc 2012 - 2013
Hamilton Sundstrand 2010 - 2012
Rockwell Collins 2006 - 2010
Swell Software 2004 - 2006
Skills
C/C++, DO-178B, ARINC 429, VectorCast, Embedded Software, Structural Coverage, Software Verification, Debuggers, Firmware, Telelogic DOORS, ClearQuest, Avionics, Visual Basic, Flight Management..., Device Drivers, TI DSPs, Graphics, Matlab, MKS Integrity, CAN bus, IEC 62304, Ada programming, Polyspace, Code Composer Studio, GreenHills, VSS, ChipView, Python, MC/DC, Surround SCM, TestTrack, Software Development, Testing, RTOS, VxWorks, Debugging, ISO 14971, Requirements Analysis, Software Engineering, Microcontrollers, Embedded Systems, Software Design, C, Software Quality..., Systems Engineering, Requirements Management, Aerospace, C++, Rational DOORS
Education
Wayne State University 2003 — 2005
MSEE, Electrical Engineering, Signal Processing/ Controls
Ryerson Polytechnic University 1992 — 1997
BSEE, Electrical Engineering
University of Alabama 1987 — 1990
Bachelor of Science (B.S), Mathematics
Aerospace/Aviation Consulting 2013 - Present
Terumo Heart Inc 2012 - 2013
Hamilton Sundstrand 2010 - 2012
Rockwell Collins 2006 - 2010
Swell Software 2004 - 2006
Skills
C/C++, DO-178B, ARINC 429, VectorCast, Embedded Software, Structural Coverage, Software Verification, Debuggers, Firmware, Telelogic DOORS, ClearQuest, Avionics, Visual Basic, Flight Management..., Device Drivers, TI DSPs, Graphics, Matlab, MKS Integrity, CAN bus, IEC 62304, Ada programming, Polyspace, Code Composer Studio, GreenHills, VSS, ChipView, Python, MC/DC, Surround SCM, TestTrack, Software Development, Testing, RTOS, VxWorks, Debugging, ISO 14971, Requirements Analysis, Software Engineering, Microcontrollers, Embedded Systems, Software Design, C, Software Quality..., Systems Engineering, Requirements Management, Aerospace, C++, Rational DOORS
Education
Wayne State University 2003 — 2005
MSEE, Electrical Engineering, Signal Processing/ Controls
Ryerson Polytechnic University 1992 — 1997
BSEE, Electrical Engineering
University of Alabama 1987 — 1990
Bachelor of Science (B.S), Mathematics
Naoya Sugiura Naoya Sugiura's Terumo Heart, Inc Experience December 2011 - Present
Job Software Development Manager at Terumo Heart, Inc.
Industry Medical Devices
Experience
Terumo Heart, Inc. December 2011 - Present
Terumo Heart, Inc. July 2007 - November 2011
Terumo April 1995 - June 2007
Skills
Software Development, Medical Device Product..., Software Requirements, Debugging, Telelogic DOORS, Embedded Software, V&V, Software Design, Object Oriented Design, C++, Software Project..., Requirements Analysis, MFC, C, Requirements Management, Software Validation, Testing, Medical Devices, FDA, ISO 13485, ISO 14971, Software Engineering, R&D, Design Control, Quality System, Validation, Quality Assurance, Computer System..., FMEA, CAPA, Cross-functional Team..., Product Launch, Rational DOORS, MS VC, IEC 62304, IBM Rational Rhapsody
Education
Shizuoka University 1989 — 1995
MS, Electronics
Terumo Heart, Inc. December 2011 - Present
Terumo Heart, Inc. July 2007 - November 2011
Terumo April 1995 - June 2007
Skills
Software Development, Medical Device Product..., Software Requirements, Debugging, Telelogic DOORS, Embedded Software, V&V, Software Design, Object Oriented Design, C++, Software Project..., Requirements Analysis, MFC, C, Requirements Management, Software Validation, Testing, Medical Devices, FDA, ISO 13485, ISO 14971, Software Engineering, R&D, Design Control, Quality System, Validation, Quality Assurance, Computer System..., FMEA, CAPA, Cross-functional Team..., Product Launch, Rational DOORS, MS VC, IEC 62304, IBM Rational Rhapsody
Education
Shizuoka University 1989 — 1995
MS, Electronics
Joshua Ball Joshua Ball's Terumo Heart, Inc Experience March 2012 - October 2012
Job Quality Control Manager
Industry Construction
Experience
Wurtec June 2015 - Present
Terumo Cardiovascular Systems June 2013 - June 2015
Invacare October 2012 - June 2013
Terumo Heart Inc. March 2012 - October 2012
Fresenius Medical Care January 2011 - March 2012
Fresenius Medical Care North America July 2004 - January 2011
Fresenius Medical Care North America December 2000 - July 2004
Skills
Fine Art Photography, Photo Editing, Creative Writing, Medical Devices, Document Management, Technical Documentation, Quality Assurance, Quality Systems, Social Media Marketing, Web 2.0, Quality Auditing, Internal Audit, Supplier Auditing, ISO standards, ISO 13485, Risk Management, Risk Analysis, Root Cause Analysis, Team Building, Supplier Quality, Process Improvement, CAPA, Cross-functional Team..., cGMP, Digital Photography, Portrait Photography, Business Portraits, Event Photography, Writing, Web Design, FMEA, Quality System, 21 CFR, Part 820, DFMEA, Quality System..., Microsoft Excel, Microsoft Office, Microsoft Word, GMP, Business Process Mapping, Continuous Improvement..., Change Control, V&V, Design Control, ISO, Image Editing, Auditing, Lean Manufacturing, Quality Control
Education
University of Toledo 2007 — 2009
Bachelor of Business Administration, Electronic Commerce
Owens Community College 2000 — 2006
Associate of Science, Business Administration Concentration
Bowsher 1994 — 1999
High School Diploma, Marketing
Wurtec June 2015 - Present
Terumo Cardiovascular Systems June 2013 - June 2015
Invacare October 2012 - June 2013
Terumo Heart Inc. March 2012 - October 2012
Fresenius Medical Care January 2011 - March 2012
Fresenius Medical Care North America July 2004 - January 2011
Fresenius Medical Care North America December 2000 - July 2004
Skills
Fine Art Photography, Photo Editing, Creative Writing, Medical Devices, Document Management, Technical Documentation, Quality Assurance, Quality Systems, Social Media Marketing, Web 2.0, Quality Auditing, Internal Audit, Supplier Auditing, ISO standards, ISO 13485, Risk Management, Risk Analysis, Root Cause Analysis, Team Building, Supplier Quality, Process Improvement, CAPA, Cross-functional Team..., cGMP, Digital Photography, Portrait Photography, Business Portraits, Event Photography, Writing, Web Design, FMEA, Quality System, 21 CFR, Part 820, DFMEA, Quality System..., Microsoft Excel, Microsoft Office, Microsoft Word, GMP, Business Process Mapping, Continuous Improvement..., Change Control, V&V, Design Control, ISO, Image Editing, Auditing, Lean Manufacturing, Quality Control
Education
University of Toledo 2007 — 2009
Bachelor of Business Administration, Electronic Commerce
Owens Community College 2000 — 2006
Associate of Science, Business Administration Concentration
Bowsher 1994 — 1999
High School Diploma, Marketing
Rebecca Mackey, PMP Rebecca Mackey, PMP's Terumo Heart, Inc Experience December 2011 - December 2012
Job Project Manager at MB Financial Bank / R3 Recruitment
Industry Management Consulting
Experience
Orchid Orthopedic Solutions November 2014 - April 2015
AAA / R-3 Recruiting May 2014 - November 2014
Terumo Cardiovascular (TCVS) January 2013 - December 2013
Terumo Heart, Inc. December 2011 - December 2012
Hickory Woods Condominium Association March 2009 - October 2012
Terumo Heart, Inc. September 2011 - December 2011
Terumo Heart, Inc. April 2008 - September 2011
SPL/Dow Chemical April 2006 - June 2007
Skills
Project Management, Leadership, Training, Project Planning, Validation, Product Launch, Editing, Public Relations, Press Releases, Management, Medical Devices, Cross-functional Team..., CRM, FDA, Strategic Planning, Corporate Communications, ISO 13485, ISO 9001, ISO 21500, Writing, News Writing, Team Building, Team Leadership, Quality Assurance, Video Editing, Product Development, Copywriting, Budgets, Newsletters, Internal Communications, Marketing Communications, Design Control, Market Research, Contract Management, Technical Writing, Strategic Communications, Social Media Marketing, HTML, Critical Chain Project..., Iso 9000, Manufacturing, Quality Management, Quality System, CAPA, Process Improvement, Strategy, Program Management
Education
Florida Tech University 2013 — 2016
Master of Business Administration (MBA), Project Management, 3.0
Wayne County Community College District 2010 — 2010
Certificate, Web Design
Central Michigan University 2003 — 2006
BAA, Integrative Public Relations, Political Science
Davenport University 1996 — 2003
AAS, Marketing
Orchid Orthopedic Solutions November 2014 - April 2015
AAA / R-3 Recruiting May 2014 - November 2014
Terumo Cardiovascular (TCVS) January 2013 - December 2013
Terumo Heart, Inc. December 2011 - December 2012
Hickory Woods Condominium Association March 2009 - October 2012
Terumo Heart, Inc. September 2011 - December 2011
Terumo Heart, Inc. April 2008 - September 2011
SPL/Dow Chemical April 2006 - June 2007
Skills
Project Management, Leadership, Training, Project Planning, Validation, Product Launch, Editing, Public Relations, Press Releases, Management, Medical Devices, Cross-functional Team..., CRM, FDA, Strategic Planning, Corporate Communications, ISO 13485, ISO 9001, ISO 21500, Writing, News Writing, Team Building, Team Leadership, Quality Assurance, Video Editing, Product Development, Copywriting, Budgets, Newsletters, Internal Communications, Marketing Communications, Design Control, Market Research, Contract Management, Technical Writing, Strategic Communications, Social Media Marketing, HTML, Critical Chain Project..., Iso 9000, Manufacturing, Quality Management, Quality System, CAPA, Process Improvement, Strategy, Program Management
Education
Florida Tech University 2013 — 2016
Master of Business Administration (MBA), Project Management, 3.0
Wayne County Community College District 2010 — 2010
Certificate, Web Design
Central Michigan University 2003 — 2006
BAA, Integrative Public Relations, Political Science
Davenport University 1996 — 2003
AAS, Marketing
Leann Christman Leann Christman's Terumo Heart, Inc Experience December 2004 - July 2008
Job
Industry Medical Devices
Experience
Hygieia, Inc August 2014 - Present
Michigan Regulatory and Quality Consulting, LLC May 2010 - Present
MC3, Inc. March 2010 - July 2014
Medtronic Spine & Biologics March 2009 - March 2010
Terumo Heart, Inc December 2004 - July 2008
Ann Arbor Public Schools July 2004 - February 2005
Eastern Michigan University July 2002 - July 2004
Skills
Regulatory Affairs, ISO 13485, FDA, ISO 14971, Design Control, CE marking, PMA, Validation, Biomedical Engineering, Root Cause Analysis, Minitab, Regulatory Submissions, Quality System, Quality Assurance, CAPA, R&D, Medical Devices, Product Development
Education
Eastern Michigan University
B.S., History and General Business
Eastern Michigan University
M.A., Educational Leadership and Counseling
Eastern Michigan University
Advanced Graduate Certificate, Quality Management
Florida Atlantic University
Accounting and Business/Management
Hygieia, Inc August 2014 - Present
Michigan Regulatory and Quality Consulting, LLC May 2010 - Present
MC3, Inc. March 2010 - July 2014
Medtronic Spine & Biologics March 2009 - March 2010
Terumo Heart, Inc December 2004 - July 2008
Ann Arbor Public Schools July 2004 - February 2005
Eastern Michigan University July 2002 - July 2004
Skills
Regulatory Affairs, ISO 13485, FDA, ISO 14971, Design Control, CE marking, PMA, Validation, Biomedical Engineering, Root Cause Analysis, Minitab, Regulatory Submissions, Quality System, Quality Assurance, CAPA, R&D, Medical Devices, Product Development
Education
Eastern Michigan University
B.S., History and General Business
Eastern Michigan University
M.A., Educational Leadership and Counseling
Eastern Michigan University
Advanced Graduate Certificate, Quality Management
Florida Atlantic University
Accounting and Business/Management
Richard Pool Richard Pool's Terumo Heart, Inc Experience April 2006 - July 2013
Job Machine Shop Supervisor at Thoratec Corporation
Industry Medical Devices
Experience
Thoratec Corporation July 2013 - Present
Terumo Heart inc. April 2006 - July 2013
Skills
Manufacturing, Medical Devices, Machining, Precision Machining, Leadership, CAD/CAM, Management, CAPA, ISO 13485, Lean Manufacturing, Quality System, Continuous Improvement, FDA, SPC, Six Sigma
Education
Baker College of Allen Park 2013 — 2015
Associates Degree, Business Administration and Management, General
Monroe Community College
Thoratec Corporation July 2013 - Present
Terumo Heart inc. April 2006 - July 2013
Skills
Manufacturing, Medical Devices, Machining, Precision Machining, Leadership, CAD/CAM, Management, CAPA, ISO 13485, Lean Manufacturing, Quality System, Continuous Improvement, FDA, SPC, Six Sigma
Education
Baker College of Allen Park 2013 — 2015
Associates Degree, Business Administration and Management, General
Monroe Community College
Sergio Delgado Sergio Delgado's Terumo Heart, Inc Experience May 2004 - June 2009
Job Principal Engineer at Edwards Lifesciences
Industry Medical Devices
Experience
Edwards Lifesciences June 2009 - Present
Terumo Heart Inc May 2004 - June 2009
Hycorr Machine Corporation October 2001 - May 2004
Pharmacia/Pfizer March 2000 - July 2001
Florida International University June 1999 - December 1999
Skills
Medical Devices, Product Development, Product Design, FDA, Six Sigma, Design of Experiments, Minitab, Materials, AutoCAD, GD&T, Microsoft Office, Spreadsheets, Pro Engineer, Nitinol, Shape Memory Alloys, Process Development, Statistics, Machine Design, Equipment Design, In Vitro, Test Management, Test Automation, Labview, Cardiovascular Devices, Heart Valves, Ventricular Assist..., Validation, Design Control, Process Simulation, R&D, ISO 13485, CAPA, ISO 14971, Creo Parametric, Catheters, Testing, Biomedical Engineering, Engineering, Manufacturing, Finite Element Analysis, FMEA, Design for Manufacturing, GMP
Education
Eastern Michigan University 2005 — 2007
Masters, Engineering Management
Florida International University 1998 — 1999
Bachelor, Mechanical Engineering
Universidad de Los Andes 1995 — 1998
Engineering, Mechanical
Edwards Lifesciences June 2009 - Present
Terumo Heart Inc May 2004 - June 2009
Hycorr Machine Corporation October 2001 - May 2004
Pharmacia/Pfizer March 2000 - July 2001
Florida International University June 1999 - December 1999
Skills
Medical Devices, Product Development, Product Design, FDA, Six Sigma, Design of Experiments, Minitab, Materials, AutoCAD, GD&T, Microsoft Office, Spreadsheets, Pro Engineer, Nitinol, Shape Memory Alloys, Process Development, Statistics, Machine Design, Equipment Design, In Vitro, Test Management, Test Automation, Labview, Cardiovascular Devices, Heart Valves, Ventricular Assist..., Validation, Design Control, Process Simulation, R&D, ISO 13485, CAPA, ISO 14971, Creo Parametric, Catheters, Testing, Biomedical Engineering, Engineering, Manufacturing, Finite Element Analysis, FMEA, Design for Manufacturing, GMP
Education
Eastern Michigan University 2005 — 2007
Masters, Engineering Management
Florida International University 1998 — 1999
Bachelor, Mechanical Engineering
Universidad de Los Andes 1995 — 1998
Engineering, Mechanical
Nitin Mehta Nitin Mehta's Terumo Heart, Inc Experience May 2008 - August 2008
Job Regulatory Affairs Specialist
Industry Medical Devices
Experience
Edwards Lifesciences April 2012 - Present
Bio-Rad Laboratories June 2009 - April 2012
Second Sight Medical Products January 2009 - April 2009
Terumo Heart, Inc. May 2008 - August 2008
Tandon July 2006 - April 2007
Skills
Regulatory Affairs, Biomedical Engineering, Clinical, FDA, Design Control, ISO 13485, CE marking, Medical Devices, CAPA, PMA, ISO 14971, Validation, V&V, Quality System, Clinical Trials, GMP, Regulatory Submissions, Regulatory Requirements, Clinical Research
Education
University of Southern California 2007 — 2009
Master of Science, Biomedical Engineering
Panjab University 2002 — 2006
B.S, Electronics & Communication
Edwards Lifesciences April 2012 - Present
Bio-Rad Laboratories June 2009 - April 2012
Second Sight Medical Products January 2009 - April 2009
Terumo Heart, Inc. May 2008 - August 2008
Tandon July 2006 - April 2007
Skills
Regulatory Affairs, Biomedical Engineering, Clinical, FDA, Design Control, ISO 13485, CE marking, Medical Devices, CAPA, PMA, ISO 14971, Validation, V&V, Quality System, Clinical Trials, GMP, Regulatory Submissions, Regulatory Requirements, Clinical Research
Education
University of Southern California 2007 — 2009
Master of Science, Biomedical Engineering
Panjab University 2002 — 2006
B.S, Electronics & Communication
Tina Leventhal Tina Leventhal's Terumo Heart, Inc Experience February 2009 - December 2009
Job Clinical Trial Manager at Aastrom Biosciences
Industry Research
Experience
Vericel Corporation (formerly Aastrom Biosciences) September 2013 - Present
CytoPherx, Inc. February 2010 - May 2013
Terumo Heart, Inc February 2009 - December 2009
University of Michigan Health System (Cardiac Surgery Section) May 2006 - February 2009
Howard Hughes Medical Institute September 2004 - May 2006
Xanodyne Pharmaceuticals March 2003 - September 2004
Athersys, Inc. May 1998 - March 2003
Skills
Clinical Research, Clinical Trials, Contract Negotiation, EDC Management/Design, Data Management, Medical Devices, FDA, Hospitals, EDC, CRO, Clinical Development, CTMS, Protocol, GCP, Biotechnology, Lifesciences, Life Sciences, Molecular Biology, Management
Education
Eastern Michigan University 2004 — 2008
Master of Science (M.S.), Clinical Research
Case Western Reserve University 1993 — 1997
Master of Science (M.S.), Genetics
Ashland University
Bachelor of Science (B.S.), Biology
St. John Central
Vericel Corporation (formerly Aastrom Biosciences) September 2013 - Present
CytoPherx, Inc. February 2010 - May 2013
Terumo Heart, Inc February 2009 - December 2009
University of Michigan Health System (Cardiac Surgery Section) May 2006 - February 2009
Howard Hughes Medical Institute September 2004 - May 2006
Xanodyne Pharmaceuticals March 2003 - September 2004
Athersys, Inc. May 1998 - March 2003
Skills
Clinical Research, Clinical Trials, Contract Negotiation, EDC Management/Design, Data Management, Medical Devices, FDA, Hospitals, EDC, CRO, Clinical Development, CTMS, Protocol, GCP, Biotechnology, Lifesciences, Life Sciences, Molecular Biology, Management
Education
Eastern Michigan University 2004 — 2008
Master of Science (M.S.), Clinical Research
Case Western Reserve University 1993 — 1997
Master of Science (M.S.), Genetics
Ashland University
Bachelor of Science (B.S.), Biology
St. John Central
Monica Hadass Monica Hadass's Terumo Heart, Inc Experience December 2011 - January 2013
Job System V&V at Covidien
Industry Medical Devices
Experience
Covidien April 2013 - Present
Terumo Heart, Inc December 2011 - January 2013
Biomedical Systems 2008 - January 2012
bausch and lomb 2004 - 2008
Amdocs 2000 - 2003
Military 1978 - 2000
Skills
Black Belt- six sigma, Computer System..., Risk Management, Software Project..., Change Management, Configuration Management, Software Configuration..., IT Management, IT Strategy, Validation, Process Improvement, Team Leadership, Quality Management, CAPA, SDLC, Software Quality..., Innovative Thinking, Quality Auditing, Business Analysis, Systems Analysis, Regulatory Requirements, Quality System, Requirements Analysis, Six Sigma, Visio, Software Documentation, Cross-functional Team..., Testing, Vendor Management, Medical Devices, Business Process, Software Development, Quality Assurance, V&V, Management, Product Development, FDA
Education
Bar-Ilan University
Study towards Master degree, Organizational Sociology
Technion - Israel Institute of Technology
Bachelor of science, Industrial and Management Engineer
Technion-Machon Technologi Le' Israel
Bachelor of Applied Science (B.A.Sc.)
Covidien April 2013 - Present
Terumo Heart, Inc December 2011 - January 2013
Biomedical Systems 2008 - January 2012
bausch and lomb 2004 - 2008
Amdocs 2000 - 2003
Military 1978 - 2000
Skills
Black Belt- six sigma, Computer System..., Risk Management, Software Project..., Change Management, Configuration Management, Software Configuration..., IT Management, IT Strategy, Validation, Process Improvement, Team Leadership, Quality Management, CAPA, SDLC, Software Quality..., Innovative Thinking, Quality Auditing, Business Analysis, Systems Analysis, Regulatory Requirements, Quality System, Requirements Analysis, Six Sigma, Visio, Software Documentation, Cross-functional Team..., Testing, Vendor Management, Medical Devices, Business Process, Software Development, Quality Assurance, V&V, Management, Product Development, FDA
Education
Bar-Ilan University
Study towards Master degree, Organizational Sociology
Technion - Israel Institute of Technology
Bachelor of science, Industrial and Management Engineer
Technion-Machon Technologi Le' Israel
Bachelor of Applied Science (B.A.Sc.)
Brian Jeffery Brian Jeffery's Terumo Heart, Inc Experience April 2010 - July 2013
Job R&D Design Engineer II at Thoratec
Industry Medical Devices
Experience
Thoratec March 2015 - Present
Thoratec July 2013 - Present
Terumo Heart Inc. April 2010 - July 2013
Rebellious Automotive Engineering June 2005 - 2013
Terumo Heart INC. April 2007 - April 2010
Terumo Heart Inc April 2005 - April 2007
Alcoa Fujicura Limited May 2004 - April 2005
Belle tire October 2002 - May 2004
Cyntell Tool and Die October 2001 - October 2002
Accurate Transmission January 1999 - October 2001
Skills
Medical Devices, Catia, Welding, Plastic Design, Custom Fabrication, Automotive, Product Design, CAD, Product Development, Injection Molding, Manufacturing, AutoCAD, FDA, Problem Solving, Prototyping, Rapid Prototyping, GD&T, R&D, Solid Modeling, Excel, Word, Team Building, Engineering, Pro/Engineer, Machining, Metal Fabrication, ISO 13485, Continuous Improvement, Pro Engineer, Solidworks
Education
Henry Ford Community College 2002 — 2005
Associates in Science, Industrial Design
Melvindale High school 1998 — 2001
Thoratec March 2015 - Present
Thoratec July 2013 - Present
Terumo Heart Inc. April 2010 - July 2013
Rebellious Automotive Engineering June 2005 - 2013
Terumo Heart INC. April 2007 - April 2010
Terumo Heart Inc April 2005 - April 2007
Alcoa Fujicura Limited May 2004 - April 2005
Belle tire October 2002 - May 2004
Cyntell Tool and Die October 2001 - October 2002
Accurate Transmission January 1999 - October 2001
Skills
Medical Devices, Catia, Welding, Plastic Design, Custom Fabrication, Automotive, Product Design, CAD, Product Development, Injection Molding, Manufacturing, AutoCAD, FDA, Problem Solving, Prototyping, Rapid Prototyping, GD&T, R&D, Solid Modeling, Excel, Word, Team Building, Engineering, Pro/Engineer, Machining, Metal Fabrication, ISO 13485, Continuous Improvement, Pro Engineer, Solidworks
Education
Henry Ford Community College 2002 — 2005
Associates in Science, Industrial Design
Melvindale High school 1998 — 2001
Oksana Ivashkevych Oksana Ivashkevych's Terumo Heart, Inc Experience September 2008 - August 2009
Job Advanced Application Engineer at Brookhaven National Laboratory
Industry Medical Devices
Experience
Brookhaven National Laboratory November 2009 - Present
Terumo Heart, Inc September 2008 - August 2009
Terumo Heart Inc August 2006 - September 2008
Micromax, Inc January 2005 - March 2006
Lucent Technology 2000 - 2003
Motorola May 1998 - March 2000
Education
Moscow Institute of Physics and Technology (State University) (MIPT) 1987 — 1993
Ms.Sci., Optics and Laser Physics with distinction
Brookhaven National Laboratory November 2009 - Present
Terumo Heart, Inc September 2008 - August 2009
Terumo Heart Inc August 2006 - September 2008
Micromax, Inc January 2005 - March 2006
Lucent Technology 2000 - 2003
Motorola May 1998 - March 2000
Education
Moscow Institute of Physics and Technology (State University) (MIPT) 1987 — 1993
Ms.Sci., Optics and Laser Physics with distinction
Kari Olds's Terumo Heart, Inc Experience 2011 - Present
Job Director of Human Resources at Terumo Heart Inc.
Industry Medical Devices
Experience
Terumo Heart Inc. 2011 - Present
LAHRA (Livingston Area Human Resources Association) 2005 - 2012
Amerisure 2006 - April 2011
Beyond Interactive 2000 - 2005
Presbyterian Villages of Michigan 1993 - 2000
Skills
Organizational..., Personnel Management, Performance Management, Succession Planning, Talent Management, Employee Relations, Performance Improvement, Onboarding, Leadership Development, Workshop Facilitation, Benefits Administration, Leadership, Human Resources, Training, Workforce Planning, Deferred Compensation, Talent Acquisition
Education
EMU
Bachelor of Business Administration
Eastern Michigan University
Master of Science (M.S.), Human Resources and Organizational Development
Wayne State University
Master of Arts, Labor and Industrial Relations
Terumo Heart Inc. 2011 - Present
LAHRA (Livingston Area Human Resources Association) 2005 - 2012
Amerisure 2006 - April 2011
Beyond Interactive 2000 - 2005
Presbyterian Villages of Michigan 1993 - 2000
Skills
Organizational..., Personnel Management, Performance Management, Succession Planning, Talent Management, Employee Relations, Performance Improvement, Onboarding, Leadership Development, Workshop Facilitation, Benefits Administration, Leadership, Human Resources, Training, Workforce Planning, Deferred Compensation, Talent Acquisition
Education
EMU
Bachelor of Business Administration
Eastern Michigan University
Master of Science (M.S.), Human Resources and Organizational Development
Wayne State University
Master of Arts, Labor and Industrial Relations
Jennifer Yue Jennifer Yue's Terumo Heart, Inc Experience November 2003 - July 2013
Job Principal Quality Engineer at MedtronicMiniMed
Industry Medical Devices
Experience
Medtronic August 2013 - Present
Terumo heart Inc. November 2003 - July 2013
Digital Security Controls 1997 - 2003
Skills
Medical Devices, ISO 13485, FMEA, R&D, FDA, Validation, Quality System, Design Control, Cross-functional Team..., CAPA, Biomedical Engineering, Testing, Root Cause Analysis, V&V, Battery Charger, Design of Experiments, Reliability Engineering, Lithium-ion Batteries, Quality Management, Process Simulation, Minitab, Six Sigma, Quality Assurance, Design for Manufacturing, Supplier Quality, GMP
Education
University of Ottawa
MSc, Electrical engineering
Beijing Institute of Technology
Bachelor's degree, Eletrical Engineering
Medtronic August 2013 - Present
Terumo heart Inc. November 2003 - July 2013
Digital Security Controls 1997 - 2003
Skills
Medical Devices, ISO 13485, FMEA, R&D, FDA, Validation, Quality System, Design Control, Cross-functional Team..., CAPA, Biomedical Engineering, Testing, Root Cause Analysis, V&V, Battery Charger, Design of Experiments, Reliability Engineering, Lithium-ion Batteries, Quality Management, Process Simulation, Minitab, Six Sigma, Quality Assurance, Design for Manufacturing, Supplier Quality, GMP
Education
University of Ottawa
MSc, Electrical engineering
Beijing Institute of Technology
Bachelor's degree, Eletrical Engineering
Victoria Knight Victoria Knight's Terumo Heart, Inc Experience July 2009 - May 2011
Job Helping people make things no matter how large or small
Industry Mechanical or Industrial Engineering
Experience
Corning Incorporated July 2015 - Present
Corning Incorporated July 2013 - Present
Leaders for Global Operations June 2011 - June 2013
General Motors June 2012 - December 2012
Terumo Heart Inc July 2009 - May 2011
Aim4A and freelance tutoring April 2009 - February 2010
Hobbs + Black Architects July 2008 - March 2009
Payne/Bouchier June 2007 - August 2007
Taylor & Burns Architects January 2007 - January 2007
Payne/Bouchier June 2006 - August 2006
Skills
Process Improvement, Lean Manufacturing, Product Development, Medical Devices, Supply Chain Management, Project Management, Leadership, Program Management, Systems Engineering, AutoCAD, CAD, Construction, Capital Projects, Manufacturing, Six Sigma, Management, Testing, Process Engineering, Engineering, Cross-functional Team...
Education
Massachusetts Institute of Technology - Sloan School of Management 2011 — 2013
MBA, Operations, 4.7/5.0
Massachusetts Institute of Technology 2011 — 2013
Master of Science (MS), Systems Engineering, 4.7/5.0
Massachusetts Institute of Technology 2004 — 2008
BS, Architecture, 4.7/5.0
Corning Incorporated July 2015 - Present
Corning Incorporated July 2013 - Present
Leaders for Global Operations June 2011 - June 2013
General Motors June 2012 - December 2012
Terumo Heart Inc July 2009 - May 2011
Aim4A and freelance tutoring April 2009 - February 2010
Hobbs + Black Architects July 2008 - March 2009
Payne/Bouchier June 2007 - August 2007
Taylor & Burns Architects January 2007 - January 2007
Payne/Bouchier June 2006 - August 2006
Skills
Process Improvement, Lean Manufacturing, Product Development, Medical Devices, Supply Chain Management, Project Management, Leadership, Program Management, Systems Engineering, AutoCAD, CAD, Construction, Capital Projects, Manufacturing, Six Sigma, Management, Testing, Process Engineering, Engineering, Cross-functional Team...
Education
Massachusetts Institute of Technology - Sloan School of Management 2011 — 2013
MBA, Operations, 4.7/5.0
Massachusetts Institute of Technology 2011 — 2013
Master of Science (MS), Systems Engineering, 4.7/5.0
Massachusetts Institute of Technology 2004 — 2008
BS, Architecture, 4.7/5.0
Evan Kydland Evan Kydland's Terumo Heart, Inc Experience May 2011 - October 2012
Job Contract Embedded Software Engineer
Industry Computer Software
Experience
United Launch Alliance February 2015 - Present
GE Aviation May 2013 - February 2015
Curtiss-Wright Controls, Electronics & Defense October 2012 - April 2013
Terumo Heart Inc May 2011 - October 2012
Curtiss-Wright Defense November 2010 - May 2011
GE Aviation July 2008 - November 2010
Smiths Aerospace March 2005 - June 2008
Boeing Company May 2001 - February 2005
V3I May 1997 - June 2001
Lockheed Aircraft Service Company January 1990 - May 1997
Skills
Software Engineering, Embedded Software, C++, Testing, C, Software Development, Embedded Systems, Systems Engineering, Software Design, Debugging, Ada, Avionics, Medical Devices, Firmware, Requirements Analysis, RTOS, JavaScript, VxWorks, Java, TCP/IP, XML, C#, Process Improvement, Configuration Management, VMware, .NET, Object Oriented Design, Linux, Perl, DO-178B, Windows, Integration, System Design, SQL, Microcontrollers, HTML, Telelogic DOORS, Eclipse, Python
Education
Rutgers University-New Brunswick 1977 — 1983
BS, BA, Math, ME
Rutgers University-New Brunswick 1977 — 1983
Bachelor's degree, Mathematics
United Launch Alliance February 2015 - Present
GE Aviation May 2013 - February 2015
Curtiss-Wright Controls, Electronics & Defense October 2012 - April 2013
Terumo Heart Inc May 2011 - October 2012
Curtiss-Wright Defense November 2010 - May 2011
GE Aviation July 2008 - November 2010
Smiths Aerospace March 2005 - June 2008
Boeing Company May 2001 - February 2005
V3I May 1997 - June 2001
Lockheed Aircraft Service Company January 1990 - May 1997
Skills
Software Engineering, Embedded Software, C++, Testing, C, Software Development, Embedded Systems, Systems Engineering, Software Design, Debugging, Ada, Avionics, Medical Devices, Firmware, Requirements Analysis, RTOS, JavaScript, VxWorks, Java, TCP/IP, XML, C#, Process Improvement, Configuration Management, VMware, .NET, Object Oriented Design, Linux, Perl, DO-178B, Windows, Integration, System Design, SQL, Microcontrollers, HTML, Telelogic DOORS, Eclipse, Python
Education
Rutgers University-New Brunswick 1977 — 1983
BS, BA, Math, ME
Rutgers University-New Brunswick 1977 — 1983
Bachelor's degree, Mathematics
William Hassel William Hassel's Terumo Heart, Inc Experience November 2010 - December 2012
Job Medical Device Consultant, 30 years experience: design, compliance, quality, risk management, regulatory
Industry Medical Devices
Experience
Depuy Synthes - Johnson & Johnson July 2013 - Present
Project MedTech, Inc. 1998 - Present
Terumo Cardiovascular Systems May 2013 - July 2013
Terumo Heart, Inc. November 2010 - December 2012
MRC, Inc. July 2010 - August 2011
AlvaMed, LLC 2005 - 2010
Baxter Healthcare 2006 - 2009
QPharma, Inc. 2003 - 2006
Quintiles Consutling December 1988 - June 1999
Aastrom Biosciences 1994 - 1998
Skills
FDA, CAPA, Validation, Medical Devices, ISO 13485, Quality System, Quality Assurance, GMP, V&V, Regulatory Affairs, Cross-functional Team..., R&D, Biotechnology, Design Control, Testing, Engineering, Commercialization, Product Launch, ISO 14971, Manufacturing, Product Development, Quality Management, Risk Management, Quality Control, FMEA, Software Documentation, Lifesciences, Clinical Trials, Technology Transfer, Biomedical Engineering, Regulatory Requirements, Root Cause Analysis, Regulatory Submissions, Computer System..., Six Sigma, Clinical Development, Quality Auditing, ISO, 21 CFR Part 11, Change Control, GxP, Process Simulation, Sop, Electrical Engineering, 60601-1 3rd Edition, Functional Requirements, Requirements Management, Requirements...
Education
Rutgers University-New Brunswick
BA, English
University of Miami
MSBE, Biomedical Engineering
Vanderbilt University
Electrical and Biomedical Engineering
Depuy Synthes - Johnson & Johnson July 2013 - Present
Project MedTech, Inc. 1998 - Present
Terumo Cardiovascular Systems May 2013 - July 2013
Terumo Heart, Inc. November 2010 - December 2012
MRC, Inc. July 2010 - August 2011
AlvaMed, LLC 2005 - 2010
Baxter Healthcare 2006 - 2009
QPharma, Inc. 2003 - 2006
Quintiles Consutling December 1988 - June 1999
Aastrom Biosciences 1994 - 1998
Skills
FDA, CAPA, Validation, Medical Devices, ISO 13485, Quality System, Quality Assurance, GMP, V&V, Regulatory Affairs, Cross-functional Team..., R&D, Biotechnology, Design Control, Testing, Engineering, Commercialization, Product Launch, ISO 14971, Manufacturing, Product Development, Quality Management, Risk Management, Quality Control, FMEA, Software Documentation, Lifesciences, Clinical Trials, Technology Transfer, Biomedical Engineering, Regulatory Requirements, Root Cause Analysis, Regulatory Submissions, Computer System..., Six Sigma, Clinical Development, Quality Auditing, ISO, 21 CFR Part 11, Change Control, GxP, Process Simulation, Sop, Electrical Engineering, 60601-1 3rd Edition, Functional Requirements, Requirements Management, Requirements...
Education
Rutgers University-New Brunswick
BA, English
University of Miami
MSBE, Biomedical Engineering
Vanderbilt University
Electrical and Biomedical Engineering
Ron Metro Ron Metro's Terumo Heart, Inc Experience 2009 - 2009
Job Vice President of Sales, VP Business Development
Industry Medical Devices
Experience
Scion BioMedical, Inc March 2015 - Present
SimQuest Solutions, Inc. August 2013 - Present
VYGON USA November 2009 - December 2012
Terumo Heart, Inc. 2009 - 2009
Kensey Nash Corp. (a subsidiary of Royal DSM) March 2007 - July 2008
Edwards Lifesciences 2004 - 2006
ACMI Corp. (acquired by Gyrus & Olympus Corp.) 2002 - 2004
VisionScope, Inc. 1998 - 2002
US Surgical Corporation, (COVIDIEN) 1997 - 1998
Cordis, a Johnson & Johnson company December 1993 - October 1997
Skills
Medical Devices, Sales Operations, Start-ups, Market Development, Product Launch, Commercialization, Operating Room, Marketing Strategy, Surgical Instruments, Sales Management, Urology, Business Development, Cardiac Surgery, Management, Vascular, Selling Skills, Healthcare, Cardiology, Sales, Disposables, Surgeons, Interventional..., Strategy, Cath Lab, Interventional Radiology, Sales Effectiveness, B2B, Product Marketing, Surgery, Cardiac, Turnaround Strategy, Generating Revenue, Strategic Sales Plans, Forecasting, Process Improvement, Sales Compensation..., Coaching, Mentoring Of Staff, Training, Contract Management, Negotiation, C-Suite Selling, Performance Metrics, Contractual Agreements
Education
Suffolk University - Sawyer School of Management
Master of Business Administration (M.B.A.), Management
University of Massachusetts Boston
BA, Marketing Management
Scion BioMedical, Inc March 2015 - Present
SimQuest Solutions, Inc. August 2013 - Present
VYGON USA November 2009 - December 2012
Terumo Heart, Inc. 2009 - 2009
Kensey Nash Corp. (a subsidiary of Royal DSM) March 2007 - July 2008
Edwards Lifesciences 2004 - 2006
ACMI Corp. (acquired by Gyrus & Olympus Corp.) 2002 - 2004
VisionScope, Inc. 1998 - 2002
US Surgical Corporation, (COVIDIEN) 1997 - 1998
Cordis, a Johnson & Johnson company December 1993 - October 1997
Skills
Medical Devices, Sales Operations, Start-ups, Market Development, Product Launch, Commercialization, Operating Room, Marketing Strategy, Surgical Instruments, Sales Management, Urology, Business Development, Cardiac Surgery, Management, Vascular, Selling Skills, Healthcare, Cardiology, Sales, Disposables, Surgeons, Interventional..., Strategy, Cath Lab, Interventional Radiology, Sales Effectiveness, B2B, Product Marketing, Surgery, Cardiac, Turnaround Strategy, Generating Revenue, Strategic Sales Plans, Forecasting, Process Improvement, Sales Compensation..., Coaching, Mentoring Of Staff, Training, Contract Management, Negotiation, C-Suite Selling, Performance Metrics, Contractual Agreements
Education
Suffolk University - Sawyer School of Management
Master of Business Administration (M.B.A.), Management
University of Massachusetts Boston
BA, Marketing Management
Debra Adams, PHR MSHRM's Terumo Heart, Inc Experience May 2006 - January 2009
Job Director of Recruitment at Dreamstyle Remodeling
Industry Human Resources
Experience
Dreamstyle Remodeling February 2015 - Present
Archway May 2014 - September 2014
HR A-la-carte July 2009 - February 2014
ZeroHourParts October 2013 - January 2014
Ann Arbor American Society for Training and Development April 2013 - January 2014
MB Financial Bank Mortgage formerly Cole Taylor Mortgage April 2012 - October 2013
Oncimmune July 2009 - January 2013
Thomson Reuters July 2011 - March 2012
General Dynamics Advanced Information Systems April 2011 - June 2011
Terumo Heart, Inc. May 2006 - January 2009
Skills
Healthcare, Organizational..., Recruitment, Human Resources, Training/Development, Talent Acquisition, Team Building, Customer Service, Employee Relations, Event Planning, Health, HRIS, Hiring, Internet, Mentoring, Microsoft Office, Social Media, Manufacturing, Photoshop, PowerPoint, Strategic Planning, Photography, Customer Relations, Problem Solving, Teaching, Team Leadership, Vendor Management, Recruiting, Talent Management, Leadership, Program Management, College Recruiting, Sales, Technical Recruiting, Training, Management, Time Management, Start-ups, Screening, PeopleSoft, Payroll, SDLC, Onboarding, Applicant Tracking..., Performance Management, Sourcing, Internet Recruiting, Workforce Planning, Consulting, Team Management
Education
Concordia University-Ann Arbor 2001 — 2003
Master of Science
Concordia University-Ann Arbor 1994 — 1996
Bachelor of Art
Dreamstyle Remodeling February 2015 - Present
Archway May 2014 - September 2014
HR A-la-carte July 2009 - February 2014
ZeroHourParts October 2013 - January 2014
Ann Arbor American Society for Training and Development April 2013 - January 2014
MB Financial Bank Mortgage formerly Cole Taylor Mortgage April 2012 - October 2013
Oncimmune July 2009 - January 2013
Thomson Reuters July 2011 - March 2012
General Dynamics Advanced Information Systems April 2011 - June 2011
Terumo Heart, Inc. May 2006 - January 2009
Skills
Healthcare, Organizational..., Recruitment, Human Resources, Training/Development, Talent Acquisition, Team Building, Customer Service, Employee Relations, Event Planning, Health, HRIS, Hiring, Internet, Mentoring, Microsoft Office, Social Media, Manufacturing, Photoshop, PowerPoint, Strategic Planning, Photography, Customer Relations, Problem Solving, Teaching, Team Leadership, Vendor Management, Recruiting, Talent Management, Leadership, Program Management, College Recruiting, Sales, Technical Recruiting, Training, Management, Time Management, Start-ups, Screening, PeopleSoft, Payroll, SDLC, Onboarding, Applicant Tracking..., Performance Management, Sourcing, Internet Recruiting, Workforce Planning, Consulting, Team Management
Education
Concordia University-Ann Arbor 2001 — 2003
Master of Science
Concordia University-Ann Arbor 1994 — 1996
Bachelor of Art
Faizan Syed Faizan Syed's Terumo Heart, Inc Experience August 2012 - July 2013
Job Manufacturing Engineering Intern at Eberspaecher
Industry Mechanical or Industrial Engineering
Experience
Faurecia Interior Systems May 2014 - September 2014
DENSO International America Inc. August 2013 - April 2014
Terumo Heart Inc. August 2012 - July 2013
Skills
Engineering, CAD, AutoCAD, Mechanical Engineering, Product Design, Unigraphics, Pro Engineer, Catia, Design for Manufacturing, Finite Element Analysis, Solidworks, FMEA, ANSYS, Rapid Prototyping, Injection Molding, GD&T, Machining, Inventor, Solid Modeling, Sheet Metal, SolidWorks
Education
Lawrence Technological University 2012 — 2016
Bachelor of Science (B.S.), Mechanical Engineering, Junior
University of Michigan-Dearborn 2012 — 2012
Bachelor of Science (B.S.), Mechanical Engineering (transferred), Sophmore
Schoolcraft College 2010 — 2012
Associate of Arts (A.A.), Liberal Arts (transferred), Freshman
Faurecia Interior Systems May 2014 - September 2014
DENSO International America Inc. August 2013 - April 2014
Terumo Heart Inc. August 2012 - July 2013
Skills
Engineering, CAD, AutoCAD, Mechanical Engineering, Product Design, Unigraphics, Pro Engineer, Catia, Design for Manufacturing, Finite Element Analysis, Solidworks, FMEA, ANSYS, Rapid Prototyping, Injection Molding, GD&T, Machining, Inventor, Solid Modeling, Sheet Metal, SolidWorks
Education
Lawrence Technological University 2012 — 2016
Bachelor of Science (B.S.), Mechanical Engineering, Junior
University of Michigan-Dearborn 2012 — 2012
Bachelor of Science (B.S.), Mechanical Engineering (transferred), Sophmore
Schoolcraft College 2010 — 2012
Associate of Arts (A.A.), Liberal Arts (transferred), Freshman
Butkiewicz David Butkiewicz David's Terumo Heart, Inc Experience May 2005 - September 2013
Job Sr. Engineering Technologist at Terumo Heart Inc.
Industry Medical Devices
Experience
DABCO 1990 - 2014
Terumo Heart Inc. May 2005 - September 2013
Advanced Modular Power systems 1991 - 2003
Skills
Manufacturing, Root Cause Analysis, FDA, ISO 14971, Medical Devices, Validation, ISO, ISO 13485, Quality System, Design of Experiments, Design Control, Minitab, CAPA, R&D, Biomedical Engineering, DMAIC, FMEA
Education
Schoolcraft College
Associate of Arts and Sciences (A.A.S.), Automotive Engineering Technology/Technician
DABCO 1990 - 2014
Terumo Heart Inc. May 2005 - September 2013
Advanced Modular Power systems 1991 - 2003
Skills
Manufacturing, Root Cause Analysis, FDA, ISO 14971, Medical Devices, Validation, ISO, ISO 13485, Quality System, Design of Experiments, Design Control, Minitab, CAPA, R&D, Biomedical Engineering, DMAIC, FMEA
Education
Schoolcraft College
Associate of Arts and Sciences (A.A.S.), Automotive Engineering Technology/Technician
Flint Jeffrey Flint Jeffrey's Terumo Heart, Inc Experience August 2012 - July 2013
Job Quality Assurance Manager at Thoratec
Industry Medical Devices
Experience
Terumo Cardiovascular Systems February 2015 - Present
Thoratec July 2013 - January 2015
Terumo Heart Inc August 2012 - July 2013
Terumo Heart Inc October 2011 - August 2012
Bard Access Systems May 2006 - September 2011
Cardiovascular Research Institute May 2006 - January 2007
Flint Land Surveying March 1994 - May 2006
Skills
Medical Devices, Quality Systems, Biomedical Engineering, Product Design, FMEA, Quality Engineering, Six Sigma, Statistics, Product Development, Data Analysis, Design Control, Validation, Testing, Minitab, ISO 13485, Root Cause Analysis, CAPA, Quality Assurance, Analysis, Cross-functional Team..., Continuous Improvement, Quality System, Engineering, FDA, Lean Manufacturing, ISO 14971, Manufacturing, Quality Control, Team Management, Test Development, Development Testing, Cardiovascular..., Quality Management, SPC, Design of Experiments, R&D, 21 CFR, Design for Manufacturing, Biomaterials, Catheters, DMAIC, ISO, CQE, IEC 60601, GMP, V&V
Education
Southern Polytechnic State University 2008 — 2011
Masters of Science, Quality Engineering
University of Utah 2004 — 2007
Bachelors of Science, Biomedical Engineering
Terumo Cardiovascular Systems February 2015 - Present
Thoratec July 2013 - January 2015
Terumo Heart Inc August 2012 - July 2013
Terumo Heart Inc October 2011 - August 2012
Bard Access Systems May 2006 - September 2011
Cardiovascular Research Institute May 2006 - January 2007
Flint Land Surveying March 1994 - May 2006
Skills
Medical Devices, Quality Systems, Biomedical Engineering, Product Design, FMEA, Quality Engineering, Six Sigma, Statistics, Product Development, Data Analysis, Design Control, Validation, Testing, Minitab, ISO 13485, Root Cause Analysis, CAPA, Quality Assurance, Analysis, Cross-functional Team..., Continuous Improvement, Quality System, Engineering, FDA, Lean Manufacturing, ISO 14971, Manufacturing, Quality Control, Team Management, Test Development, Development Testing, Cardiovascular..., Quality Management, SPC, Design of Experiments, R&D, 21 CFR, Design for Manufacturing, Biomaterials, Catheters, DMAIC, ISO, CQE, IEC 60601, GMP, V&V
Education
Southern Polytechnic State University 2008 — 2011
Masters of Science, Quality Engineering
University of Utah 2004 — 2007
Bachelors of Science, Biomedical Engineering
Andrea Jewell's Terumo Heart, Inc Experience April 2008 - June 2010
Job Office Administrator at Liebherr Gear Technology
Industry Industrial Automation
Experience
Liebherr Gear Technology January 2013 - Present
Onago Farms June 2010 - January 2013
Terumo Heart, Inc. April 2008 - June 2010
Pall Life Sciences July 2003 - July 2007
Skills
Lotus Notes, Microsoft Office, Medical Devices, Clinical Research, Event Planning, Social Media, Marketing, Public Speaking, Invoicing, Product Development, Project Planning, Concur, Logistics, Leadership Development, Outlook, Executive..., Calendaring, Heavy Calendaring, Expense Reports, Executive Support, Spreadsheets, Management, Budgets, Process Improvement, Customer Service, Project Management, Team Building, Purchasing, Manufacturing
Education
Eastern Michigan University 2013 — 2019
Bachelor's Degree, Zoology/Animal Biology
Cleary University 2005 — 2007
BBA, Business Management
Cleary University 2004 — 2005
Associate's degree, Accounting Technology
Liebherr Gear Technology January 2013 - Present
Onago Farms June 2010 - January 2013
Terumo Heart, Inc. April 2008 - June 2010
Pall Life Sciences July 2003 - July 2007
Skills
Lotus Notes, Microsoft Office, Medical Devices, Clinical Research, Event Planning, Social Media, Marketing, Public Speaking, Invoicing, Product Development, Project Planning, Concur, Logistics, Leadership Development, Outlook, Executive..., Calendaring, Heavy Calendaring, Expense Reports, Executive Support, Spreadsheets, Management, Budgets, Process Improvement, Customer Service, Project Management, Team Building, Purchasing, Manufacturing
Education
Eastern Michigan University 2013 — 2019
Bachelor's Degree, Zoology/Animal Biology
Cleary University 2005 — 2007
BBA, Business Management
Cleary University 2004 — 2005
Associate's degree, Accounting Technology
Gregg Harris Gregg Harris's Terumo Heart, Inc Experience May 2002 - June 2005
Job Technology Assessment Engineer & Business Development Professional
Industry Medical Devices
Experience
MicroSystems Engineering, Inc August 2011 - Present
TEMP Expertise, LLC November 2010 - Present
Stereotaxis, Inc June 2005 - November 2010
Terumo Heart, Inc May 2002 - June 2005
Biotronik 1992 - 2002
University Medical Center of East Carolina - Pitt County 1986 - 1992
Morristown Memorial Hospital June 1983 - December 1985
Skills
Competitve Product..., Pre-clinical Testing, Clinical Applications, Clinical User Testing, Product Education, Website Design, Technical Writing, Market Analysis, Physician Relations, Mentoring, Requirements Gathering, Requirements..., Exhibition Management, International Marketing, Literature Reviews, Launch Of New Products, Clinical Research, Clinical Pharmacology, Product Launch, Positioning, Competitive Analysis, Marketing Strategy, Education, Testing, Troubleshooting, Medical Devices, Biomedical Engineering, Web Design, Cardiology, Product Management, Clinical Development, Business Development, Cross-functional Team..., Market Development, Global Marketing, FDA, Commercialization, Start-ups, Vascular, Design Control, ISO 13485, Clinical Trials, R&D, Validation, Medical Imaging, Regulatory Affairs, Hardware Diagnostics, Surgeons, Surgical Instruments, Orthopedic
Education
Duke University 1979 — 1983
BS, BME/Zoology
Rutgers, The State University of New Jersey-New Brunswick 1983 — 1985
Physiology, Master's Program
University of Phoenix 2000 — 2002
MBA, Marketing
MicroSystems Engineering, Inc August 2011 - Present
TEMP Expertise, LLC November 2010 - Present
Stereotaxis, Inc June 2005 - November 2010
Terumo Heart, Inc May 2002 - June 2005
Biotronik 1992 - 2002
University Medical Center of East Carolina - Pitt County 1986 - 1992
Morristown Memorial Hospital June 1983 - December 1985
Skills
Competitve Product..., Pre-clinical Testing, Clinical Applications, Clinical User Testing, Product Education, Website Design, Technical Writing, Market Analysis, Physician Relations, Mentoring, Requirements Gathering, Requirements..., Exhibition Management, International Marketing, Literature Reviews, Launch Of New Products, Clinical Research, Clinical Pharmacology, Product Launch, Positioning, Competitive Analysis, Marketing Strategy, Education, Testing, Troubleshooting, Medical Devices, Biomedical Engineering, Web Design, Cardiology, Product Management, Clinical Development, Business Development, Cross-functional Team..., Market Development, Global Marketing, FDA, Commercialization, Start-ups, Vascular, Design Control, ISO 13485, Clinical Trials, R&D, Validation, Medical Imaging, Regulatory Affairs, Hardware Diagnostics, Surgeons, Surgical Instruments, Orthopedic
Education
Duke University 1979 — 1983
BS, BME/Zoology
Rutgers, The State University of New Jersey-New Brunswick 1983 — 1985
Physiology, Master's Program
University of Phoenix 2000 — 2002
MBA, Marketing
Rebecca Brooks Rebecca Brooks's Terumo Heart, Inc Experience 2005 - 2006
Job Marketing Manager, BioSurgery at Baxter International Inc.
Industry Medical Devices
Experience
Baxter International Inc. September 2015 - Present
Zimmer 2013 - August 2015
Zimmer 2009 - 2013
Life Spine, Inc. 2006 - 2009
Terumo Heart, Inc. 2005 - 2006
Skills
Regulatory Affairs, Medical Devices, FDA, ISO 13485, Product Launch, Design Control, Orthopedic, Quality System, CAPA, Orthopedics, Market Development, Surgical Instruments, Surgery, Spine, Biomedical Engineering, Validation, Regulatory Submissions, Product Development, Salesforce.com, WebEx, SharePoint
Education
University of Michigan 2002 — 2006
Bachelor's, Communication Studies and Psychology
Baxter International Inc. September 2015 - Present
Zimmer 2013 - August 2015
Zimmer 2009 - 2013
Life Spine, Inc. 2006 - 2009
Terumo Heart, Inc. 2005 - 2006
Skills
Regulatory Affairs, Medical Devices, FDA, ISO 13485, Product Launch, Design Control, Orthopedic, Quality System, CAPA, Orthopedics, Market Development, Surgical Instruments, Surgery, Spine, Biomedical Engineering, Validation, Regulatory Submissions, Product Development, Salesforce.com, WebEx, SharePoint
Education
University of Michigan 2002 — 2006
Bachelor's, Communication Studies and Psychology
Kathryn Teer Kathryn Teer's Terumo Heart, Inc Experience April 2009 - February 2010
Job Sr. Manager, Corporate Communications at Plex Systems, Inc.
Industry Public Relations and Communications
Experience
Plex Systems, Inc. March 2015 - Present
Plex Systems, Inc. March 2012 - March 2015
Airfoil Public Relations March 2010 - March 2012
Terumo Heart, Inc April 2009 - February 2010
American Heart Association August 2006 - April 2008
Comcast Cable March 2002 - August 2006
Viviano Flower Shop, Inc. September 2001 - March 2002
Marx Layne & Company November 2000 - July 2001
Southwestern Oakland Cable Commission March 1999 - November 2000
Skills
Media Relations, Internal Communications, Executive Communications, Spokesperson Training, National Media Relations, Event Planning, Volunteer Management, Marketing Communications, Public Relations, Writing, Speech Writing, Automotive, SaaS, Non-profit..., Fundraising, Social Media, Social Networking, Corporate Social..., Public Speaking, Executive Positioning, Community Relations, Corporate Communications, Event Management, Special Events, Strategic Communications, Crisis Communications, Press Releases, Communications Strategy, Crisis Management, Newsletters, Blogging, Brand Awareness, Social Media Monitoring, Communications Planning, Message Development, Community Outreach, Advertising, Communication Training, Community Development, Nonprofits, Social Media Measurement, Marketing, Messaging, Publicity, Creative Direction, Copywriting, Analyst Relations, Sponsorship, Program Management, Management
Education
University of Detroit Mercy
BA, Communications
Plex Systems, Inc. March 2015 - Present
Plex Systems, Inc. March 2012 - March 2015
Airfoil Public Relations March 2010 - March 2012
Terumo Heart, Inc April 2009 - February 2010
American Heart Association August 2006 - April 2008
Comcast Cable March 2002 - August 2006
Viviano Flower Shop, Inc. September 2001 - March 2002
Marx Layne & Company November 2000 - July 2001
Southwestern Oakland Cable Commission March 1999 - November 2000
Skills
Media Relations, Internal Communications, Executive Communications, Spokesperson Training, National Media Relations, Event Planning, Volunteer Management, Marketing Communications, Public Relations, Writing, Speech Writing, Automotive, SaaS, Non-profit..., Fundraising, Social Media, Social Networking, Corporate Social..., Public Speaking, Executive Positioning, Community Relations, Corporate Communications, Event Management, Special Events, Strategic Communications, Crisis Communications, Press Releases, Communications Strategy, Crisis Management, Newsletters, Blogging, Brand Awareness, Social Media Monitoring, Communications Planning, Message Development, Community Outreach, Advertising, Communication Training, Community Development, Nonprofits, Social Media Measurement, Marketing, Messaging, Publicity, Creative Direction, Copywriting, Analyst Relations, Sponsorship, Program Management, Management
Education
University of Detroit Mercy
BA, Communications
Jon Lock's Terumo Heart, Inc Experience July 2013 - August 2015
Job Project Manager at Volcano Corporation
Industry Medical Devices
Experience
Volcano Corporation Project ManagerVolcano CorporationSeptember 2015 - Present
Terumo Heart Inc. July 2013 - August 2015
Terumo Heart Inc January 2011 - 2013
Terumo Heart Inc March 2006 - January 2011
Terumo Cardiovascular Systems April 2000 - April 2006
Wirtz Manufacturing Company June 1996 - March 2000
Skills
ISO 13485, V&V, Validation, Design Control, Medical Devices, FDA, GMP, CAPA, FMEA, Quality System, Cross-functional Team..., Engineering, Root Cause Analysis, ISO, Design of Experiments, Management, Biomedical Engineering, Product Launch, ISO 14971, Lean Manufacturing, Project Management..., Supplier Quality, Minitab, 21 CFR Part 11, GD&T, R&D, Six Sigma, Injection Molding, SPC, DMAIC, Program Management, SolidWorks
Education
Boston University 2012 — 2016
Master of Science (M.S.), Project Management
Michigan Technological University 1992 — 1996
Bachelor of Science (BS), Mechanical Engineering
Volcano Corporation Project ManagerVolcano CorporationSeptember 2015 - Present
Terumo Heart Inc. July 2013 - August 2015
Terumo Heart Inc January 2011 - 2013
Terumo Heart Inc March 2006 - January 2011
Terumo Cardiovascular Systems April 2000 - April 2006
Wirtz Manufacturing Company June 1996 - March 2000
Skills
ISO 13485, V&V, Validation, Design Control, Medical Devices, FDA, GMP, CAPA, FMEA, Quality System, Cross-functional Team..., Engineering, Root Cause Analysis, ISO, Design of Experiments, Management, Biomedical Engineering, Product Launch, ISO 14971, Lean Manufacturing, Project Management..., Supplier Quality, Minitab, 21 CFR Part 11, GD&T, R&D, Six Sigma, Injection Molding, SPC, DMAIC, Program Management, SolidWorks
Education
Boston University 2012 — 2016
Master of Science (M.S.), Project Management
Michigan Technological University 1992 — 1996
Bachelor of Science (BS), Mechanical Engineering
Frederick Macatula Frederick Macatula's Terumo Heart, Inc Experience November 2013 - Present
Job Quality Engineer I at Terumo Heart, Inc.
Industry Medical Devices
Experience
Terumo Heart, Inc. November 2013 - Present
Terumo Heart, Inc. March 2012 - August 2013
Bubble Island February 2009 - July 2011
Macy's December 2007 - February 2008
Skills
Biomedical Engineering, Medical Devices, Product Development, R&D, Quality Assurance, CAPA, Minitab, Matlab, Labview, Solidworks, Mechanical Testing, Engineering, Research, Product Design, Java, User Acceptance Testing, R, Validation, ISO 13485
Education
University of Michigan 2008 — 2011
B.S.E. in Biomedical Engineering, Biomechanical Concentration
University of Michigan-Flint 2006 — 2008
General Engineering
Terumo Heart, Inc. November 2013 - Present
Terumo Heart, Inc. March 2012 - August 2013
Bubble Island February 2009 - July 2011
Macy's December 2007 - February 2008
Skills
Biomedical Engineering, Medical Devices, Product Development, R&D, Quality Assurance, CAPA, Minitab, Matlab, Labview, Solidworks, Mechanical Testing, Engineering, Research, Product Design, Java, User Acceptance Testing, R, Validation, ISO 13485
Education
University of Michigan 2008 — 2011
B.S.E. in Biomedical Engineering, Biomechanical Concentration
University of Michigan-Flint 2006 — 2008
General Engineering
David Muczynski David Muczynski's Terumo Heart, Inc Experience August 2013 - Present
Job Quality System Manager at Terumo Heart, Inc.
Industry Medical Devices
Experience
Terumo Heart, Inc. August 2013 - Present
Terumo Heart, Inc. February 2007 - August 2013
Rainbow Rehabilitation Centers August 2008 - February 2009
University of Michigan Health System January 2008 - February 2009
Skills
Certified Quality..., Six Sigma, ISO 13485, CAPA, Root Cause Analysis, Healthcare, Medical Devices, FDA, Statistics, Technical Writing, Microsoft Office, Quality System, Minitab, Microsoft Excel, DMAIC, Process Improvement, Design of Experiments, Change Control, Continuous Improvement, Product Development, V&V, Manufacturing
Education
Florida Institute of Technology 2015 — 2017
Masters of Science, Quality Management
University of Michigan 2012 — 2013
Bachelor of Science (BS), Certified Six Sigma Black Belt Professional Course
University of Michigan 2004 — 2008
Bachelor of Science (B.S.), Brain, Behavior & Cognitive Science (BBCS)
Terumo Heart, Inc. August 2013 - Present
Terumo Heart, Inc. February 2007 - August 2013
Rainbow Rehabilitation Centers August 2008 - February 2009
University of Michigan Health System January 2008 - February 2009
Skills
Certified Quality..., Six Sigma, ISO 13485, CAPA, Root Cause Analysis, Healthcare, Medical Devices, FDA, Statistics, Technical Writing, Microsoft Office, Quality System, Minitab, Microsoft Excel, DMAIC, Process Improvement, Design of Experiments, Change Control, Continuous Improvement, Product Development, V&V, Manufacturing
Education
Florida Institute of Technology 2015 — 2017
Masters of Science, Quality Management
University of Michigan 2012 — 2013
Bachelor of Science (BS), Certified Six Sigma Black Belt Professional Course
University of Michigan 2004 — 2008
Bachelor of Science (B.S.), Brain, Behavior & Cognitive Science (BBCS)
Kristi Cameron, CSSBB Kristi Cameron, CSSBB's Terumo Heart, Inc Experience June 2006 - November 2011
Job Senior Engineer I Product Development at Terumo Cardiovascular Systems
Industry Medical Devices
Experience
Terumo Cardiovascular Systems March 2012 - Present
Xoran Technologies November 2011 - March 2012
Terumo Heart Inc. June 2006 - November 2011
Terumo Heart Inc. August 2001 - June 2006
University of Michigan, Orthopedics Research Laboratory September 2000 - December 2000
Medtronic, Inc May 2000 - September 2000
Ford Motor Company May 1999 - September 1999
Ford Motor Company May 1998 - September 1998
Skills
Medical Devices, Manufacturing Processes, Six Sigma, Solidworks, Pro Engineer, Product Development, Testing, ISO 13485, V&V, Design of Experiments, GD&T, FMEA, Minitab, DMAIC, Engineering, Validation, R&D, Biomedical Engineering, GMP, Cross-functional Team..., Labview, FDA, Product Design, Quality System, Design Control, Manufacturing, Continuous Improvement, Root Cause Analysis, ISO 14971, Design for Manufacturing, CAPA, Manufacturing..., SPC, Injection Molding
Education
University of Michigan 2000 — 2001
Master of Science, Biomedical Engineering
University of Michigan 1996 — 2000
Bachelor of Science, Mechanical Engineering
Novi High School 1992 — 1996
Diploma
Terumo Cardiovascular Systems March 2012 - Present
Xoran Technologies November 2011 - March 2012
Terumo Heart Inc. June 2006 - November 2011
Terumo Heart Inc. August 2001 - June 2006
University of Michigan, Orthopedics Research Laboratory September 2000 - December 2000
Medtronic, Inc May 2000 - September 2000
Ford Motor Company May 1999 - September 1999
Ford Motor Company May 1998 - September 1998
Skills
Medical Devices, Manufacturing Processes, Six Sigma, Solidworks, Pro Engineer, Product Development, Testing, ISO 13485, V&V, Design of Experiments, GD&T, FMEA, Minitab, DMAIC, Engineering, Validation, R&D, Biomedical Engineering, GMP, Cross-functional Team..., Labview, FDA, Product Design, Quality System, Design Control, Manufacturing, Continuous Improvement, Root Cause Analysis, ISO 14971, Design for Manufacturing, CAPA, Manufacturing..., SPC, Injection Molding
Education
University of Michigan 2000 — 2001
Master of Science, Biomedical Engineering
University of Michigan 1996 — 2000
Bachelor of Science, Mechanical Engineering
Novi High School 1992 — 1996
Diploma
Matt Baun Matt Baun's Terumo Heart, Inc Experience July 2013 - March 2015
Job Experienced Clinical Support and Clinical Research Medical Device Professional
Industry Medical Devices
Experience
Terumo Heart, Inc. July 2013 - March 2015
Terumo Heart, Inc. July 2009 - July 2013
Ventracor, Inc. November 2007 - July 2009
Bioreactor Group, University of Pittsburgh February 2003 - November 2007
UPMC October 2001 - November 2007
University of Pittsburgh December 2001 - November 2002
University of Pittsburgh January 2001 - December 2001
Intellicardia, Inc. August 2000 - December 2000
Respironics Inc May 1998 - August 2000
Skills
Clinical Trials, Medical Devices, Clinical Research, Biomedical Engineering, FDA, Surgery, Hospitals, Healthcare, Product Development, Validation, Training, Research, Data Analysis, Software Documentation, Interventional..., R&D, Biotechnology, Cardiology, CAPA, Human Factors, Cardiac Surgery, Mechanical Circulatory..., GCP
Education
Penn State University 1993 — 1998
BS, Mechanical Engineering, Minor Biomedical Engineering, Minor Engineering Mechanics
Smethport Area Jr.-Sr. High School 1988 — 1993
Terumo Heart, Inc. July 2013 - March 2015
Terumo Heart, Inc. July 2009 - July 2013
Ventracor, Inc. November 2007 - July 2009
Bioreactor Group, University of Pittsburgh February 2003 - November 2007
UPMC October 2001 - November 2007
University of Pittsburgh December 2001 - November 2002
University of Pittsburgh January 2001 - December 2001
Intellicardia, Inc. August 2000 - December 2000
Respironics Inc May 1998 - August 2000
Skills
Clinical Trials, Medical Devices, Clinical Research, Biomedical Engineering, FDA, Surgery, Hospitals, Healthcare, Product Development, Validation, Training, Research, Data Analysis, Software Documentation, Interventional..., R&D, Biotechnology, Cardiology, CAPA, Human Factors, Cardiac Surgery, Mechanical Circulatory..., GCP
Education
Penn State University 1993 — 1998
BS, Mechanical Engineering, Minor Biomedical Engineering, Minor Engineering Mechanics
Smethport Area Jr.-Sr. High School 1988 — 1993
Rohan Mendonza Rohan Mendonza's Terumo Heart, Inc Experience May 2004 - July 2009
Job Site Leader at Amazon
Industry Retail
Experience
Amazon June 2015 - Present
Amazon July 2013 - May 2015
Amazon.com March 2011 - July 2013
Amazon.com July 2009 - March 2011
Terumo Heart Inc. May 2004 - July 2009
Dimensional Control Systems July 2003 - May 2004
GE Medical Systems September 2000 - June 2003
Skills
Cross-functional Team..., Operational Excellence, Change Management, Operations Management, Six Sigma, Lean Manufacturing, Product Development, Continuous Improvement, Leadership, Management Consulting, Process Engineering, Supply Chain Management, Project Planning, Supply Chain, Manufacturing, Management, Project Management, Process Improvement, Business Analysis, Business Process..., Program Management, Strategy, Forecasting, Product Management, Logistics, Vendor Management, Competitive Analysis, Business Strategy, Procurement, Kaizen
Education
University of Michigan - Stephen M. Ross School of Business 2005 — 2009
MBA, Operations and Corporate Strategy
Bangalore University 1996 — 2000
BS, Mechanical Engineering
Amazon June 2015 - Present
Amazon July 2013 - May 2015
Amazon.com March 2011 - July 2013
Amazon.com July 2009 - March 2011
Terumo Heart Inc. May 2004 - July 2009
Dimensional Control Systems July 2003 - May 2004
GE Medical Systems September 2000 - June 2003
Skills
Cross-functional Team..., Operational Excellence, Change Management, Operations Management, Six Sigma, Lean Manufacturing, Product Development, Continuous Improvement, Leadership, Management Consulting, Process Engineering, Supply Chain Management, Project Planning, Supply Chain, Manufacturing, Management, Project Management, Process Improvement, Business Analysis, Business Process..., Program Management, Strategy, Forecasting, Product Management, Logistics, Vendor Management, Competitive Analysis, Business Strategy, Procurement, Kaizen
Education
University of Michigan - Stephen M. Ross School of Business 2005 — 2009
MBA, Operations and Corporate Strategy
Bangalore University 1996 — 2000
BS, Mechanical Engineering
Subhan Khan Subhan Khan's Terumo Heart, Inc Experience July 2004 - April 2010
Job VP, Research and Development at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical December 2012 - Present
Maquet Cardiovascular April 2010 - October 2012
Terumo Heart, Inc July 2004 - April 2010
Bolton Medical 2003 - 2004
Novoste Corporation 1998 - 2003
Boston Scientific 1995 - 1998
CR Bard 1993 - 1995
Boston Scientific 1993 - 1993
Skills
Medical Devices, ISO 13485, Design Control, FDA, R&D, Biomedical Engineering, Quality System, Commercialization, Validation, Product Development, Start-ups, Product Launch, Strategic Planning, Strategic Negotiations, Overseas Experience, Intellectual Property, New Business Development, Business Planning, Manufacturing, Strategic Roadmaps, KOL development, Biomaterials, Cross-functional Team..., ISO, Strategy, Continuous Improvement, Process Simulation, V&V, Injection Molding, GMP, Medical Device R&D, Biotechnology, Capital Equipment, CAPA, Surgical Instruments, Market Development, Design for Manufacturing, Product Design
Education
University of Massachusetts at Lowell 1990 — 1993
Bachelor of Science (B.Sc.), Mechanical Engineering
University of Massachusetts at Lowell
Master of Science (M.Sc.), Plastics Engineering
St. Jude Medical December 2012 - Present
Maquet Cardiovascular April 2010 - October 2012
Terumo Heart, Inc July 2004 - April 2010
Bolton Medical 2003 - 2004
Novoste Corporation 1998 - 2003
Boston Scientific 1995 - 1998
CR Bard 1993 - 1995
Boston Scientific 1993 - 1993
Skills
Medical Devices, ISO 13485, Design Control, FDA, R&D, Biomedical Engineering, Quality System, Commercialization, Validation, Product Development, Start-ups, Product Launch, Strategic Planning, Strategic Negotiations, Overseas Experience, Intellectual Property, New Business Development, Business Planning, Manufacturing, Strategic Roadmaps, KOL development, Biomaterials, Cross-functional Team..., ISO, Strategy, Continuous Improvement, Process Simulation, V&V, Injection Molding, GMP, Medical Device R&D, Biotechnology, Capital Equipment, CAPA, Surgical Instruments, Market Development, Design for Manufacturing, Product Design
Education
University of Massachusetts at Lowell 1990 — 1993
Bachelor of Science (B.Sc.), Mechanical Engineering
University of Massachusetts at Lowell
Master of Science (M.Sc.), Plastics Engineering
J. Mark Hendricks, MBA's Terumo Heart, Inc Experience November 2012 - July 2013
Job Learning & Development Professional
Industry Human Resources
Experience
Terumo Global Cardiovascular Group August 2011 - Present
Terumo Heart, Inc. November 2012 - July 2013
Consultant August 2009 - August 2011
TTi Global September 2008 - May 2009
SPX - Valley Forge 2007 - 2007
Comau Pico February 2005 - October 2006
DMR Solutions, LLC 2002 - 2004
Spring Arbor University 1990 - 2002
Skills
Learning Management, Curriculum Development, Instructional Design, Technical Training, Quality Management, Organizational..., Process Improvement, Coaching, Budgets, Project Management, Strategic Planning, Vendor Management, Leadership, Educational Leadership, E-Learning, L&D Strategy, Learning Analytics, Training ROI, Learning & Development..., Instructional Technology, Learning Management..., E-learning..., E-learning Development, ADDIE, SCORM, Adult Learning Theory, Curriculum Mapping, Blended Learning, Training Delivery, Class III Medical..., Cardiovascular Devices, ISO 13485, 21 CFR, CAPA, Quality System..., Performance Improvement, Organizational Behavior, Operations Management, Talent Management, Business Analysis, Needs Analysis, Program Management, Training, Change Management, Human Resources, Six Sigma, Quality Assurance, CRM, Management, Cross-functional Team...
Education
Eastern Michigan University
Master of Arts (MA), Educational Media and Technology, 3.92
Cleary University
MBA, Management, 3.89
Spring Arbor University
BA, Liberal Arts, Cum Laude
University of Oxford
Post-graduate research
Terumo Global Cardiovascular Group August 2011 - Present
Terumo Heart, Inc. November 2012 - July 2013
Consultant August 2009 - August 2011
TTi Global September 2008 - May 2009
SPX - Valley Forge 2007 - 2007
Comau Pico February 2005 - October 2006
DMR Solutions, LLC 2002 - 2004
Spring Arbor University 1990 - 2002
Skills
Learning Management, Curriculum Development, Instructional Design, Technical Training, Quality Management, Organizational..., Process Improvement, Coaching, Budgets, Project Management, Strategic Planning, Vendor Management, Leadership, Educational Leadership, E-Learning, L&D Strategy, Learning Analytics, Training ROI, Learning & Development..., Instructional Technology, Learning Management..., E-learning..., E-learning Development, ADDIE, SCORM, Adult Learning Theory, Curriculum Mapping, Blended Learning, Training Delivery, Class III Medical..., Cardiovascular Devices, ISO 13485, 21 CFR, CAPA, Quality System..., Performance Improvement, Organizational Behavior, Operations Management, Talent Management, Business Analysis, Needs Analysis, Program Management, Training, Change Management, Human Resources, Six Sigma, Quality Assurance, CRM, Management, Cross-functional Team...
Education
Eastern Michigan University
Master of Arts (MA), Educational Media and Technology, 3.92
Cleary University
MBA, Management, 3.89
Spring Arbor University
BA, Liberal Arts, Cum Laude
University of Oxford
Post-graduate research
Mark Morsehead, PMP's Terumo Heart, Inc Experience October 2011 - Present
Job Program Director at TERUMO Heart Inc
Industry Medical Devices
Experience
TERUMO Heart Inc October 2011 - Present
Terumo Heart March 2011 - October 2011
ImageSoft, Inc. September 2009 - March 2011
Creative Technology Services 2006 - September 2009
MSX International 1999 - 2006
Excel Industries Inc 1997 - 1999
Excel Industries January 1989 - January 1997
Excel Industries Inc. 1987 - 1989
Design & Engineering Services 1978 - 1987
Skills
Medical Devices, Program Management, Continuous Improvement, Product Launch, Product Development, ISO 13485, Quality System, Biomedical Engineering, Quality Assurance, Design Control, CAPA, Manufacturing, Injection Molding, Supplier Quality, Automotive, Engineering, Engineering Management, FDA, Product Design, R&D, Design of Experiments, Plastics, Cross-functional Team..., Validation, Root Cause Analysis, V&V, DMAIC, Lean Manufacturing, FMEA, Six Sigma, Manufacturing..., Design for Manufacturing, SPC, Minitab, Quality Management, Commercialization, Process Simulation, Kaizen, PPAP
Education
Central Michigan University 1973 — 1977
TERUMO Heart Inc October 2011 - Present
Terumo Heart March 2011 - October 2011
ImageSoft, Inc. September 2009 - March 2011
Creative Technology Services 2006 - September 2009
MSX International 1999 - 2006
Excel Industries Inc 1997 - 1999
Excel Industries January 1989 - January 1997
Excel Industries Inc. 1987 - 1989
Design & Engineering Services 1978 - 1987
Skills
Medical Devices, Program Management, Continuous Improvement, Product Launch, Product Development, ISO 13485, Quality System, Biomedical Engineering, Quality Assurance, Design Control, CAPA, Manufacturing, Injection Molding, Supplier Quality, Automotive, Engineering, Engineering Management, FDA, Product Design, R&D, Design of Experiments, Plastics, Cross-functional Team..., Validation, Root Cause Analysis, V&V, DMAIC, Lean Manufacturing, FMEA, Six Sigma, Manufacturing..., Design for Manufacturing, SPC, Minitab, Quality Management, Commercialization, Process Simulation, Kaizen, PPAP
Education
Central Michigan University 1973 — 1977
Lisa Henn's Terumo Heart, Inc Experience January 2005 - October 2007
Job Ph.D. Candidate at Division of Biostatistics, University of Minnesota
Industry Research
Experience
Division of Biostatistics, University of Minnesota September 2010 - Present
Department of Biostatistics, University of Michigan September 2008 - August 2010
Lisa Henn and Associates January 2008 - August 2008
Terumo Heart Inc. January 2005 - October 2007
Datex-Ohmeda (now GE Medical) February 2002 - January 2005
Datex-Ohmeda June 1998 - January 2002
Ohmeda (then Datex-Ohmeda) September 1994 - June 1998
Skills
Project Management, Cross-functional Team..., Product Development, Statistics, Statistical Modeling, Medical Devices, Data Analysis, FDA, Manufacturing, Six Sigma, Lean Manufacturing, Design of Experiments, Research, Leadership, Biomedical Engineering, Validation, Continuous Improvement, Management, Minitab, Technical Writing, Design Control, ISO 13485, GD&T, R, Engineering, Testing, Root Cause Analysis, R&D
Education
University of Minnesota-Twin Cities 2010 — 2015
PhD, Biostatistics
University of Michigan 2008 — 2010
MS, Biostatistics
The Ohio State University
MSME, Mechanical Engineering
Washington University in St. Louis
BSME, Mechanical Engineering
Division of Biostatistics, University of Minnesota September 2010 - Present
Department of Biostatistics, University of Michigan September 2008 - August 2010
Lisa Henn and Associates January 2008 - August 2008
Terumo Heart Inc. January 2005 - October 2007
Datex-Ohmeda (now GE Medical) February 2002 - January 2005
Datex-Ohmeda June 1998 - January 2002
Ohmeda (then Datex-Ohmeda) September 1994 - June 1998
Skills
Project Management, Cross-functional Team..., Product Development, Statistics, Statistical Modeling, Medical Devices, Data Analysis, FDA, Manufacturing, Six Sigma, Lean Manufacturing, Design of Experiments, Research, Leadership, Biomedical Engineering, Validation, Continuous Improvement, Management, Minitab, Technical Writing, Design Control, ISO 13485, GD&T, R, Engineering, Testing, Root Cause Analysis, R&D
Education
University of Minnesota-Twin Cities 2010 — 2015
PhD, Biostatistics
University of Michigan 2008 — 2010
MS, Biostatistics
The Ohio State University
MSME, Mechanical Engineering
Washington University in St. Louis
BSME, Mechanical Engineering
Jon Schabert's Terumo Heart, Inc Experience June 2010 - October 2011
Job Sr. Manager R&D, Access Group at Stryker
Industry Medical Devices
Experience
Stryker Neurovascular October 2011 - Present
Terumo Heart, Inc. June 2010 - October 2011
Boston Scientific CRM May 2007 - May 2010
Boston Scientific CRM November 2006 - April 2007
Guidant December 2005 - October 2006
Guidant December 2002 - November 2005
Guidant July 2001 - November 2002
US Navy May 1994 - July 2001
Skills
R&D, Design Control, Root Cause Problem..., Technology Product..., Intellectual Property, Project Management, Mechanical Product..., Medical Devices, Product Development, Manufacturing..., FDA, Validation, Biomedical Engineering, Engineering, ISO 13485, Manufacturing, Cross-functional Team..., Engineering Management, Program Management..., V&V, Catheters, Quality System
Education
Marquette University 1999 — 2001
Master of Business Administration (MBA)
Rensselaer Polytechnic Institute 1990 — 1994
BS, Biomedical Engineering
Stryker Neurovascular October 2011 - Present
Terumo Heart, Inc. June 2010 - October 2011
Boston Scientific CRM May 2007 - May 2010
Boston Scientific CRM November 2006 - April 2007
Guidant December 2005 - October 2006
Guidant December 2002 - November 2005
Guidant July 2001 - November 2002
US Navy May 1994 - July 2001
Skills
R&D, Design Control, Root Cause Problem..., Technology Product..., Intellectual Property, Project Management, Mechanical Product..., Medical Devices, Product Development, Manufacturing..., FDA, Validation, Biomedical Engineering, Engineering, ISO 13485, Manufacturing, Cross-functional Team..., Engineering Management, Program Management..., V&V, Catheters, Quality System
Education
Marquette University 1999 — 2001
Master of Business Administration (MBA)
Rensselaer Polytechnic Institute 1990 — 1994
BS, Biomedical Engineering
Susan Hinz's Terumo Heart, Inc Experience 2006 - 2007
Job Senior Manager, Clinical Research at Cordis
Industry Medical Devices
Experience
Cordis January 2014 - Present
Independent Consultant January 2000 - Present
Hansen Medical August 2013 - January 2014
Auxogyn, Inc. August 2010 - March 2013
Abbott Diabetes Care December 2007 - July 2010
Alquest, Inc. 2007 - 2007
Terumo Heart Inc. 2006 - 2007
Terumo Heart, Inc. 2005 - 2006
Independent Consultant January 2000 - April 2005
Medtronic December 1998 - March 2000
Skills
Regulatory Affairs, Clinical Development, Clinical Study Design, Strategic Planning, Medical Writing, Budgets, Auditing, Clinical Practices, Performance Management, Medical Devices, Policy, System Monitoring, FDA, Team Facilitation, Publications, Clinical Research, Clinical Trials, ISO 13485, Design Control, CAPA, ISO 14971, CTMS, V&V, GCP, Neurology, Biomedical Engineering, Quality System, R&D, Biotechnology, Regulatory Submissions, Sop, CRO, Lifesciences
Education
University of Iowa 1980 — 1983
MA, Speech Pathology/Speech Science
Augustana College 1976 — 1980
BA, Speech Pathology, Spanish
Cordis January 2014 - Present
Independent Consultant January 2000 - Present
Hansen Medical August 2013 - January 2014
Auxogyn, Inc. August 2010 - March 2013
Abbott Diabetes Care December 2007 - July 2010
Alquest, Inc. 2007 - 2007
Terumo Heart Inc. 2006 - 2007
Terumo Heart, Inc. 2005 - 2006
Independent Consultant January 2000 - April 2005
Medtronic December 1998 - March 2000
Skills
Regulatory Affairs, Clinical Development, Clinical Study Design, Strategic Planning, Medical Writing, Budgets, Auditing, Clinical Practices, Performance Management, Medical Devices, Policy, System Monitoring, FDA, Team Facilitation, Publications, Clinical Research, Clinical Trials, ISO 13485, Design Control, CAPA, ISO 14971, CTMS, V&V, GCP, Neurology, Biomedical Engineering, Quality System, R&D, Biotechnology, Regulatory Submissions, Sop, CRO, Lifesciences
Education
University of Iowa 1980 — 1983
MA, Speech Pathology/Speech Science
Augustana College 1976 — 1980
BA, Speech Pathology, Spanish
Sunil Dasara, CSSBB's Terumo Heart, Inc Experience April 2010 - July 2013
Job Sr. R&D Engineer at Thoratec
Industry Medical Devices
Experience
Thoratec July 2013 - Present
Terumo Heart, Inc April 2010 - July 2013
Terumo Heart, Inc June 2007 - April 2010
Terumo Heart, Inc April 2004 - June 2007
Onward Technologies March 2002 - March 2004
Satyam Computer Services Limited May 2000 - March 2002
Andhra University 1999 - 2000
Skills
Pro Engineer, GD&T, Medical Devices, Product Design, FMEA, ISO 13485, Design for Manufacturing, Six Sigma, Solidworks, Product Development, Engineering, FDA, Product Management, CAD, Automotive, Design Control, Design of Experiments, R&D, Quality System, Minitab, DMAIC, Root Cause Analysis, Injection Molding, V&V, Biomedical Engineering, Manufacturing, CAPA, SPC, Lean Manufacturing, Manufacturing...
Education
University of Michigan-Dearborn 2007 — 2010
MSE, Manufacturing Systems Engineering
Andhra University 1995 — 1999
B.E., Mechanical Engineering
Gandhi Institute of Technology and Management 1995 — 1999
B.E., Mechanical
Vikas 1993 — 1995
Thoratec July 2013 - Present
Terumo Heart, Inc April 2010 - July 2013
Terumo Heart, Inc June 2007 - April 2010
Terumo Heart, Inc April 2004 - June 2007
Onward Technologies March 2002 - March 2004
Satyam Computer Services Limited May 2000 - March 2002
Andhra University 1999 - 2000
Skills
Pro Engineer, GD&T, Medical Devices, Product Design, FMEA, ISO 13485, Design for Manufacturing, Six Sigma, Solidworks, Product Development, Engineering, FDA, Product Management, CAD, Automotive, Design Control, Design of Experiments, R&D, Quality System, Minitab, DMAIC, Root Cause Analysis, Injection Molding, V&V, Biomedical Engineering, Manufacturing, CAPA, SPC, Lean Manufacturing, Manufacturing...
Education
University of Michigan-Dearborn 2007 — 2010
MSE, Manufacturing Systems Engineering
Andhra University 1995 — 1999
B.E., Mechanical Engineering
Gandhi Institute of Technology and Management 1995 — 1999
B.E., Mechanical
Vikas 1993 — 1995
Ryan Skene, CPP, CSSBB's Terumo Heart, Inc Experience January 2015 - Present
Job Senior Engineer II at Terumo Heart Inc.
Industry Medical Devices
Experience
Terumo Heart Inc. January 2015 - Present
Thoratec July 2013 - January 2015
Terumo Heart Inc. May 2012 - July 2013
Terumo Heart Inc. August 2005 - September 2012
Boston Scientific June 2002 - July 2005
Skills
ISO 13485, Medical Devices, Quality System, Design Control, CAPA, FDA, Packaging, Six Sigma, Design of Experiments, FMEA, GMP, Minitab, Product Development, Quality Assurance, Quality Auditing, R, Testing, V, Validation
Education
Ohio University 2011 — 2014
Master of Engineering Management, Engineering Management
Michigan State University 1997 — 2002
B.S., Engineering Arts/Packaging
Terumo Heart Inc. January 2015 - Present
Thoratec July 2013 - January 2015
Terumo Heart Inc. May 2012 - July 2013
Terumo Heart Inc. August 2005 - September 2012
Boston Scientific June 2002 - July 2005
Skills
ISO 13485, Medical Devices, Quality System, Design Control, CAPA, FDA, Packaging, Six Sigma, Design of Experiments, FMEA, GMP, Minitab, Product Development, Quality Assurance, Quality Auditing, R, Testing, V, Validation
Education
Ohio University 2011 — 2014
Master of Engineering Management, Engineering Management
Michigan State University 1997 — 2002
B.S., Engineering Arts/Packaging
Carmen Fox's Terumo Heart, Inc Experience 2008 - 2013
Job Strategic Sales and Marketing Manager at LifeLine Sciences, LLC
Industry Marketing and Advertising
Experience
LifeLine Sciences, LLC 2014 - Present
NuStep Inc. 2014 - 2014
Terumo Heart Inc. 2008 - 2013
MARS Advertising 2007 - 2008
Corbett 2003 - 2007
Hamilton Communications Group 2000 - 2003
Playboy Enterprises, Inc. 1998 - 2000
The Second City 1997 - 1997
Second City Communications 1993 - 1997
Skills
Integrated Marketing, Cross-functional Team..., Marketing Strategy, Interactive Marketing, Advertising, Social Media Marketing, Product Development, Marketing Communications, Strategy, Digital Marketing, Marketing, Relationship Marketing, Creative Strategy, Email Marketing, Social Media
Education
Columbia College Chicago 1990 — 1992
BA, Broadcast Journalism
University of Saskatchewan 1985 — 1989
Bachelor of Arts (BA), Political Science
LifeLine Sciences, LLC 2014 - Present
NuStep Inc. 2014 - 2014
Terumo Heart Inc. 2008 - 2013
MARS Advertising 2007 - 2008
Corbett 2003 - 2007
Hamilton Communications Group 2000 - 2003
Playboy Enterprises, Inc. 1998 - 2000
The Second City 1997 - 1997
Second City Communications 1993 - 1997
Skills
Integrated Marketing, Cross-functional Team..., Marketing Strategy, Interactive Marketing, Advertising, Social Media Marketing, Product Development, Marketing Communications, Strategy, Digital Marketing, Marketing, Relationship Marketing, Creative Strategy, Email Marketing, Social Media
Education
Columbia College Chicago 1990 — 1992
BA, Broadcast Journalism
University of Saskatchewan 1985 — 1989
Bachelor of Arts (BA), Political Science
John Toigo's Terumo Heart, Inc Experience 2004 - 2007
Job Regulatory Affairs and Quality Assurance Consultant
Industry Medical Devices
Experience
RESQ Solutions 2007 - Present
Miller Technical Services (MTS) 2010 - 2013
Toigo Group International 2004 - 2012
TUV 1999 - 2010
Terumo Heart, Inc 2004 - 2007
BioPort Corporation 2001 - 2004
Sarns/3M Healthcare 1990 - 1999
Bio-Rad Laboratories/EVSCO Pharmaceuticals 1982 - 1985
RalTech Scientific Services 1979 - 1982
Skills
Medical Devices, ISO 13485, Quality Systems, CAPA, Process Validation, QSR, Auditing, Design Control, FDA, Quality Assurance, cGMP, FMEA, Risk Management, Regulatory Affairs, ISO 14971, Aseptic Processing, CE marking
Education
TTHS
University of Maryland College Park
Master of Science (MS), Medical Microbiology and Bacteriology
RESQ Solutions 2007 - Present
Miller Technical Services (MTS) 2010 - 2013
Toigo Group International 2004 - 2012
TUV 1999 - 2010
Terumo Heart, Inc 2004 - 2007
BioPort Corporation 2001 - 2004
Sarns/3M Healthcare 1990 - 1999
Bio-Rad Laboratories/EVSCO Pharmaceuticals 1982 - 1985
RalTech Scientific Services 1979 - 1982
Skills
Medical Devices, ISO 13485, Quality Systems, CAPA, Process Validation, QSR, Auditing, Design Control, FDA, Quality Assurance, cGMP, FMEA, Risk Management, Regulatory Affairs, ISO 14971, Aseptic Processing, CE marking
Education
TTHS
University of Maryland College Park
Master of Science (MS), Medical Microbiology and Bacteriology
Dale Wakevainen's Terumo Heart, Inc Experience 2002 - 2010
Job Instrumentation Engineer at Vericel Corporation
Industry Medical Devices
Experience
Vericel Corporation July 2012 - Present
Terumo Heart Inc 2002 - 2010
Skills
ISO 13485, Design Control, FDA, R&D, V&V, Cross-functional Team..., Medical Devices, CAPA, Biomedical Engineering, Validation, FMEA, ISO 14971, Quality System, Product Development
Education
Tri-State University
Vericel Corporation July 2012 - Present
Terumo Heart Inc 2002 - 2010
Skills
ISO 13485, Design Control, FDA, R&D, V&V, Cross-functional Team..., Medical Devices, CAPA, Biomedical Engineering, Validation, FMEA, ISO 14971, Quality System, Product Development
Education
Tri-State University
Jeremy Otter's Terumo Heart, Inc Experience July 2013 - Present
Job Director of Quality at Terumo Heart, Inc.
Industry Medical Devices
Experience
Terumo Heart, Inc. July 2013 - Present
Terumo Heart, Inc. May 2010 - July 2013
Terumo Heart, Inc. July 2007 - May 2010
Terumo Heart, Inc June 2005 - July 2007
BioPort Corporation July 2002 - June 2005
Skills
FDA, ISO 13485, CAPA, V&V, Validation, Medical Devices, Quality System, GMP, Design Control, Change Control, 21 CFR Part 11, Sop, Regulatory Affairs, Pharmaceutical Industry, Computer System..., Biotechnology, Biomedical Engineering, FMEA, ISO 14971, Cross-functional Team..., Aseptic Processing, Quality Assurance
Education
Michigan State University 1997 — 2002
Bachelor of Science (B.S.), Chemical Engineering
Terumo Heart, Inc. July 2013 - Present
Terumo Heart, Inc. May 2010 - July 2013
Terumo Heart, Inc. July 2007 - May 2010
Terumo Heart, Inc June 2005 - July 2007
BioPort Corporation July 2002 - June 2005
Skills
FDA, ISO 13485, CAPA, V&V, Validation, Medical Devices, Quality System, GMP, Design Control, Change Control, 21 CFR Part 11, Sop, Regulatory Affairs, Pharmaceutical Industry, Computer System..., Biotechnology, Biomedical Engineering, FMEA, ISO 14971, Cross-functional Team..., Aseptic Processing, Quality Assurance
Education
Michigan State University 1997 — 2002
Bachelor of Science (B.S.), Chemical Engineering
Mary Beth Kepler's Terumo Heart, Inc Experience December 2004 - May 2006
Job MBK Biomedical Consulting Clinical/Regulatory Consultant
Industry Medical Devices
Experience
Berlin Heart Inc November 2013 - Present
MBK Biomedical Consulting LLC August 2006 - Present
Sunshine Heart Incorporated January 2012 - November 2013
Berlin Heart Inc. April 2006 - January 2012
Terumo Cardiovascular Systems May 2006 - November 2006
Terumo Heart, Inc. December 2004 - May 2006
Medtronic October 2002 - December 2004
HeartStent June 2002 - October 2002
Abiomed August 2001 - September 2001
Artificial Heart - Univ Medical Ctr - Arizona December 1993 - August 2001
Skills
Medical Devices, FDA, Clinical Trials, Clinical Research, Regulatory Affairs, Quality Assurance, PMA, Cardiology, Clinical Development, Biotechnology, Cross-functional Team..., Biomedical Engineering, CE marking, Healthcare, Hospitals, ISO 13485, Product Development, Product Launch, Quality System, Regulatory Submissions
Education
University of Phoenix 1998 — 2000
MBA, Healthcare Finance
Texas A&M University 1986 — 1993
BSBE, Bioengineering
Berlin Heart Inc November 2013 - Present
MBK Biomedical Consulting LLC August 2006 - Present
Sunshine Heart Incorporated January 2012 - November 2013
Berlin Heart Inc. April 2006 - January 2012
Terumo Cardiovascular Systems May 2006 - November 2006
Terumo Heart, Inc. December 2004 - May 2006
Medtronic October 2002 - December 2004
HeartStent June 2002 - October 2002
Abiomed August 2001 - September 2001
Artificial Heart - Univ Medical Ctr - Arizona December 1993 - August 2001
Skills
Medical Devices, FDA, Clinical Trials, Clinical Research, Regulatory Affairs, Quality Assurance, PMA, Cardiology, Clinical Development, Biotechnology, Cross-functional Team..., Biomedical Engineering, CE marking, Healthcare, Hospitals, ISO 13485, Product Development, Product Launch, Quality System, Regulatory Submissions
Education
University of Phoenix 1998 — 2000
MBA, Healthcare Finance
Texas A&M University 1986 — 1993
BSBE, Bioengineering
Brad Rainier's Terumo Heart, Inc Experience January 2008 - June 2013
Job Sr Engineering Manager R&D at Thoratec
Industry Medical Devices
Experience
Thoratec July 2013 - Present
Terumo Heart, Inc. January 2008 - June 2013
Sparton Corporation 2003 - 2008
ViaCirq 2000 - 2003
Eli Lilly and Company, PDS 2000 - 2000
United Medical Manufacturing 1998 - 2000
HemoCleanse, Inc 1988 - 1997
Ash Medical Systems 1988 - 1991
Ash Medical Systems 1988 - 1991
Ash Medical Systems 1988 - 1991
Skills
Medical Devices, Product Development, R&D, FDA, Design Control, ISO 14971, Process Capability, ISO 13485, FMEA, Manufacturing, Systems Engineering, CAPA, Design for Manufacturing, Biomedical Engineering, Validation, V&V, Design of Experiments, Product Launch, Quality System, Engineering, ISO, Commercialization, GMP, Manufacturing..., Cross-functional Team..., Minitab, Biomaterials, SPC, Injection Molding, DMAIC, Root Cause Analysis, Product Design, Process Simulation, Six Sigma, Medical Device R&D, Lean Manufacturing, Quality Auditing, Surgical Instruments, 21 CFR Part 11, Market Development, Capital Equipment, Interventional..., Regulatory Affairs, Hardware Diagnostics, Disposables, CE marking, Biotechnology, Change Control, Vascular, 21 CFR
Education
Purdue University 1984 — 1988
Bachelor of Science (B.S.), Electrical Engineering Technologies/Technicians
Thoratec July 2013 - Present
Terumo Heart, Inc. January 2008 - June 2013
Sparton Corporation 2003 - 2008
ViaCirq 2000 - 2003
Eli Lilly and Company, PDS 2000 - 2000
United Medical Manufacturing 1998 - 2000
HemoCleanse, Inc 1988 - 1997
Ash Medical Systems 1988 - 1991
Ash Medical Systems 1988 - 1991
Ash Medical Systems 1988 - 1991
Skills
Medical Devices, Product Development, R&D, FDA, Design Control, ISO 14971, Process Capability, ISO 13485, FMEA, Manufacturing, Systems Engineering, CAPA, Design for Manufacturing, Biomedical Engineering, Validation, V&V, Design of Experiments, Product Launch, Quality System, Engineering, ISO, Commercialization, GMP, Manufacturing..., Cross-functional Team..., Minitab, Biomaterials, SPC, Injection Molding, DMAIC, Root Cause Analysis, Product Design, Process Simulation, Six Sigma, Medical Device R&D, Lean Manufacturing, Quality Auditing, Surgical Instruments, 21 CFR Part 11, Market Development, Capital Equipment, Interventional..., Regulatory Affairs, Hardware Diagnostics, Disposables, CE marking, Biotechnology, Change Control, Vascular, 21 CFR
Education
Purdue University 1984 — 1988
Bachelor of Science (B.S.), Electrical Engineering Technologies/Technicians
Todd Cazallis's Terumo Heart, Inc Experience August 2008 - October 2008
Job Civilian Electrical Engineer
Industry Military
Experience
US Army March 2010 - Present
DCS Corp November 2008 - March 2010
Terumo Heart, Inc August 2008 - October 2008
TK Holdings July 2004 - July 2008
Takata 2004 - 2008
Kimball Electronics May 2001 - July 2004
VDO Siemens 1999 - 2001
Boeing June 1994 - May 1999
Skills
Data Acquisition, Integration, Testing, Engineering, Automotive, Vector CANalyzer, Manufacturing, SPC, Electronics, DFMEA, FMEA, TS16949, Quality System
Education
Purdue University 1991 — 1994
Bachelor of Science (BS), Electrical and Electronics Engineering
US Army March 2010 - Present
DCS Corp November 2008 - March 2010
Terumo Heart, Inc August 2008 - October 2008
TK Holdings July 2004 - July 2008
Takata 2004 - 2008
Kimball Electronics May 2001 - July 2004
VDO Siemens 1999 - 2001
Boeing June 1994 - May 1999
Skills
Data Acquisition, Integration, Testing, Engineering, Automotive, Vector CANalyzer, Manufacturing, SPC, Electronics, DFMEA, FMEA, TS16949, Quality System
Education
Purdue University 1991 — 1994
Bachelor of Science (BS), Electrical and Electronics Engineering
Ann Livernois's Terumo Heart, Inc Experience 2009 - 2013
Job Science and Math Tutor; Substitute Teacher
Industry Biotechnology
Experience
Fowlerville School District October 2014 - Present
ann's Tutoring 2013 - Present
Terumo Heart, Inc 2009 - 2013
THI October 2006 - June 2009
Compliance Specialist 2004 - 2006
Emergent BioSolutions (formerly BioPort) 2001 - 2004
BioPort Corporation, Lansing, MI. 2001 - 2004
John Henry Packaging Company 1999 - 2001
Proctor and Gamble / Richardson Vicks 1990 - 1992
Proctor and Gamble / Richardson Vicks 1990 - 1992
Skills
FDA, V&V, CAPA, Medical Devices, Quality System, Manufacturing, ISO 13485, Cross-functional Team..., Design Control, Quality Auditing, GMP, Change Control, GxP, Regulatory Affairs, Validation, ISO 14971, Quality Assurance, Biopharmaceuticals, Pharmaceutical Industry, Root Cause Analysis, Product Launch, Biotechnology, Quality Control, Sop, Regulatory Requirements, Regulatory Submissions, Quality Management, Technology Transfer, Six Sigma, Aseptic Processing, GLP, 21 CFR Part 11
Education
Northeastern University 2009 — 2012
MS, Regulatory Affairs
Charter Oak State College
Bachelors, Chemistry
Fowlerville School District October 2014 - Present
ann's Tutoring 2013 - Present
Terumo Heart, Inc 2009 - 2013
THI October 2006 - June 2009
Compliance Specialist 2004 - 2006
Emergent BioSolutions (formerly BioPort) 2001 - 2004
BioPort Corporation, Lansing, MI. 2001 - 2004
John Henry Packaging Company 1999 - 2001
Proctor and Gamble / Richardson Vicks 1990 - 1992
Proctor and Gamble / Richardson Vicks 1990 - 1992
Skills
FDA, V&V, CAPA, Medical Devices, Quality System, Manufacturing, ISO 13485, Cross-functional Team..., Design Control, Quality Auditing, GMP, Change Control, GxP, Regulatory Affairs, Validation, ISO 14971, Quality Assurance, Biopharmaceuticals, Pharmaceutical Industry, Root Cause Analysis, Product Launch, Biotechnology, Quality Control, Sop, Regulatory Requirements, Regulatory Submissions, Quality Management, Technology Transfer, Six Sigma, Aseptic Processing, GLP, 21 CFR Part 11
Education
Northeastern University 2009 — 2012
MS, Regulatory Affairs
Charter Oak State College
Bachelors, Chemistry
Brett LaBelle's Terumo Heart, Inc Experience 2006 - Present
Job Quality Assurance Manager at Terumo Heart, Inc.
Industry Medical Devices
Experience
Terumo Heart, Inc. 2006 - Present
Pall Life Sciences 1998 - 2006
Pall Corporation 1992 - 1998
Skills
ISO 13485, Design of Experiments, Lean Manufacturing, Design Control, ISO, Supplier Quality, Quality Assurance, Medical Devices, GMP, Quality System, CAPA, FDA, Laboratory, Validation, V&V, ISO 14971, Microbiology, Manufacturing, Management, Quality Auditing, Process Improvement
Education
Eastern Michigan University 1998 — 2002
Quality
Purdue University 1989 — 1992
BS, Biology Education
Terumo Heart, Inc. 2006 - Present
Pall Life Sciences 1998 - 2006
Pall Corporation 1992 - 1998
Skills
ISO 13485, Design of Experiments, Lean Manufacturing, Design Control, ISO, Supplier Quality, Quality Assurance, Medical Devices, GMP, Quality System, CAPA, FDA, Laboratory, Validation, V&V, ISO 14971, Microbiology, Manufacturing, Management, Quality Auditing, Process Improvement
Education
Eastern Michigan University 1998 — 2002
Quality
Purdue University 1989 — 1992
BS, Biology Education
Eric Bushrow's Terumo Heart, Inc Experience September 2012 - Present
Job Quality Specialist II at Terumo Heart, Inc.
Industry Biotechnology
Experience
Terumo Heart, Inc. September 2012 - Present
Karmanos Cancer Institute August 2008 - Present
Eric's Aquatics 2013 - 2013
Eric's Aquatics 2013 - 2013
Digilab Genomic Solutions April 2007 - August 2008
University of Michigan Health System June 2006 - March 2007
Skills
Medical Devices, Biotechnology, FDA, Laboratory, ISO 13485, Validation
Education
Western Michigan University 2001 — 2005
Eastern Michigan University 1999 — 2001
B.S., Biology
Terumo Heart, Inc. September 2012 - Present
Karmanos Cancer Institute August 2008 - Present
Eric's Aquatics 2013 - 2013
Eric's Aquatics 2013 - 2013
Digilab Genomic Solutions April 2007 - August 2008
University of Michigan Health System June 2006 - March 2007
Skills
Medical Devices, Biotechnology, FDA, Laboratory, ISO 13485, Validation
Education
Western Michigan University 2001 — 2005
Eastern Michigan University 1999 — 2001
B.S., Biology
Hartman Douglas's Terumo Heart, Inc Experience June 2007 - September 2013
Job Quality Assurance Auditor at Steico Industries
Industry Real Estate
Experience
Steico Industries January 2015 - Present
Keller Williams Real Estate May 2013 - October 2014
Terumo Heart Inc June 2007 - September 2013
Terumo Heart Inc. June 2006 - June 2007
Skills
CAPA, Quality System, Medical Devices, ISO 13485, FDA, V&V, Validation, Manufacturing..., GMP, Design Control, Quality Auditing, ISO 14971, Root Cause Analysis, Supplier Quality, Quality Management, FMEA, DMAIC, Quality Assurance, Minitab, Process Improvement, ISO, Design of Experiments, SPC, Quality Control
Education
Central Washington University 1985 — 1990
BS, Business
Steico Industries January 2015 - Present
Keller Williams Real Estate May 2013 - October 2014
Terumo Heart Inc June 2007 - September 2013
Terumo Heart Inc. June 2006 - June 2007
Skills
CAPA, Quality System, Medical Devices, ISO 13485, FDA, V&V, Validation, Manufacturing..., GMP, Design Control, Quality Auditing, ISO 14971, Root Cause Analysis, Supplier Quality, Quality Management, FMEA, DMAIC, Quality Assurance, Minitab, Process Improvement, ISO, Design of Experiments, SPC, Quality Control
Education
Central Washington University 1985 — 1990
BS, Business
Jennifer DeChalk's Terumo Heart, Inc Experience April 2015 - Present
Job Director, Supply Chain at Terumo Heart Inc.
Industry Medical Devices
Experience
Terumo Heart Inc. April 2015 - Present
Terumo Heart Inc. June 2012 - March 2015
Terumo Heart Inc. May 2011 - May 2012
Terumo Heart Inc. June 2010 - May 2011
Terumo Heart Inc. November 2005 - May 2010
Rockwell Medical Technologies June 2002 - November 2005
Medtronic February 1998 - June 2002
Keebler Sunshine February 1997 - November 1997
Bristol Myers Squibb / Mead Johnson Division July 1994 - February 1997
Bristol Myers Squibb / Mead Johnson Division September 1992 - July 1994
Skills
Supply Chain, 21 CFR Part 11, Production Planning, Medical Devices, FDA, Cross-functional Team..., CAPA, Continuous Improvement, Quality System, ISO, ISO 13485, GMP, Manufacturing, R&D, Regulatory Affairs
Education
Michigan State University 1986 — 1990
BS, Food Science
Terumo Heart Inc. April 2015 - Present
Terumo Heart Inc. June 2012 - March 2015
Terumo Heart Inc. May 2011 - May 2012
Terumo Heart Inc. June 2010 - May 2011
Terumo Heart Inc. November 2005 - May 2010
Rockwell Medical Technologies June 2002 - November 2005
Medtronic February 1998 - June 2002
Keebler Sunshine February 1997 - November 1997
Bristol Myers Squibb / Mead Johnson Division July 1994 - February 1997
Bristol Myers Squibb / Mead Johnson Division September 1992 - July 1994
Skills
Supply Chain, 21 CFR Part 11, Production Planning, Medical Devices, FDA, Cross-functional Team..., CAPA, Continuous Improvement, Quality System, ISO, ISO 13485, GMP, Manufacturing, R&D, Regulatory Affairs
Education
Michigan State University 1986 — 1990
BS, Food Science
Bill Pinon's Terumo Heart, Inc Experience 2008 - July 2013
Job Principal at Pinon Med Pharm Consulting
Industry Biotechnology
Experience
Pinon Med Pharm Consulting July 2013 - Present
Pinon Med Pharm Consulting July 2013 - Present
Terumo Heart, Inc 2008 - July 2013
Bioheart Inc 2007 - 2008
Cordis 2003 - 2007
Centocor 1998 - 2002
Skills
Medical Devices, Biotechnology, Clinical Trials, Operating Room, Cardiology, Market Development, Product Launch, Commercialization, Interventional..., Vascular, Capital Equipment, Surgeons, Disposables, FDA, ISO 13485, Cross-functional Team..., New Business Development, Pharmaceutical Industry, Surgical Instruments, Orthopedic, Biomedical Engineering, Interventional Radiology, Hardware Diagnostics, Global Marketing, Sales Effectiveness, Surgery, Urology, Pharmaceutical Sales, Neurosurgery, Oncology, Spine, Neurology, Medical Imaging, Cath Lab, Dermatology, Gastroenterology, Managed Care, Vascular Surgery, Sales Force Development
Education
University of Oregon
Bachelor of Science (BSc), Biology/Biological Sciences, General
Pinon Med Pharm Consulting July 2013 - Present
Pinon Med Pharm Consulting July 2013 - Present
Terumo Heart, Inc 2008 - July 2013
Bioheart Inc 2007 - 2008
Cordis 2003 - 2007
Centocor 1998 - 2002
Skills
Medical Devices, Biotechnology, Clinical Trials, Operating Room, Cardiology, Market Development, Product Launch, Commercialization, Interventional..., Vascular, Capital Equipment, Surgeons, Disposables, FDA, ISO 13485, Cross-functional Team..., New Business Development, Pharmaceutical Industry, Surgical Instruments, Orthopedic, Biomedical Engineering, Interventional Radiology, Hardware Diagnostics, Global Marketing, Sales Effectiveness, Surgery, Urology, Pharmaceutical Sales, Neurosurgery, Oncology, Spine, Neurology, Medical Imaging, Cath Lab, Dermatology, Gastroenterology, Managed Care, Vascular Surgery, Sales Force Development
Education
University of Oregon
Bachelor of Science (BSc), Biology/Biological Sciences, General
Pam Briegel's Terumo Heart, Inc Experience June 2005 - Present
Job Configuration Associate at Terumo Heart Inc.
Industry Biotechnology
Experience
Terumo Heart Inc. June 2005 - Present
Skills
Medical Devices
Education
Eastern Michigan University 1966 — 2003
Bachelor of Science, Business, Social Sciences, Language Arts
Terumo Heart Inc. June 2005 - Present
Skills
Medical Devices
Education
Eastern Michigan University 1966 — 2003
Bachelor of Science, Business, Social Sciences, Language Arts
ANYIO ATEGHANG's Terumo Heart, Inc Experience October 2006 - September 2012
Job Senior QA Compliance Auditor at CARACO
Industry Medical Devices
Experience
Caraco Pharmaceutical Laboratories August 2013 - Present
TERUMO HEART INC October 2006 - September 2012
Dentsply Pharmaceuticals September 2003 - July 2006
Bone Care International November 2000 - August 2003
Ganes Chemicals April 2000 - November 2000
Skills
Internal Audits, Product Development..., GMP Compliance, Quality System, Quality Assurance, Quality Management, ISO 13485, 21CFR211, 21CFR820, FDA, Quality Auditing
Education
University of Minnesota-Twin Cities
Microbiology
Caraco Pharmaceutical Laboratories August 2013 - Present
TERUMO HEART INC October 2006 - September 2012
Dentsply Pharmaceuticals September 2003 - July 2006
Bone Care International November 2000 - August 2003
Ganes Chemicals April 2000 - November 2000
Skills
Internal Audits, Product Development..., GMP Compliance, Quality System, Quality Assurance, Quality Management, ISO 13485, 21CFR211, 21CFR820, FDA, Quality Auditing
Education
University of Minnesota-Twin Cities
Microbiology
Ema Soc's Terumo Heart, Inc Experience April 2008 - December 2009
Job Senior Buyer at Schneider Electric
Industry Electrical/Electronic Manufacturing
Experience
Schneider Electric August 2014 - Present
Medallion Instrumentation Systems June 2011 - August 2014
Amcor PET Packaging June 2010 - June 2011
Terumo Heart Inc April 2008 - December 2009
Froude Hofmann 2002 - 2008
US Industrial Tool and Supply September 1998 - June 2002
Soc Design 1995 - 1998
Motors Insurance Co 1994 - 1995
Burger King Corporation 1989 - 1994
Zetatrans 1987 - 1989
Skills
Strategic Sourcing, Continuous Improvement, Supply Chain, Procurement, Cross-functional Team..., Purchasing, Automotive, Manufacturing, Supply Management, Global Sourcing, MRP, Product Development, Logistics, Sourcing, Contract Negotiation, ISO, Supplier Development, Supply Chain Management, Engineering, Negotiation, Six Sigma, Pricing, Project Planning, Materials, Lean Manufacturing
Education
University of Belgrade 1979 — 1984
BS, Political Sciences
University of Belgrade 1979 — 1984
Bachelors, Political Science and Government
Schneider Electric August 2014 - Present
Medallion Instrumentation Systems June 2011 - August 2014
Amcor PET Packaging June 2010 - June 2011
Terumo Heart Inc April 2008 - December 2009
Froude Hofmann 2002 - 2008
US Industrial Tool and Supply September 1998 - June 2002
Soc Design 1995 - 1998
Motors Insurance Co 1994 - 1995
Burger King Corporation 1989 - 1994
Zetatrans 1987 - 1989
Skills
Strategic Sourcing, Continuous Improvement, Supply Chain, Procurement, Cross-functional Team..., Purchasing, Automotive, Manufacturing, Supply Management, Global Sourcing, MRP, Product Development, Logistics, Sourcing, Contract Negotiation, ISO, Supplier Development, Supply Chain Management, Engineering, Negotiation, Six Sigma, Pricing, Project Planning, Materials, Lean Manufacturing
Education
University of Belgrade 1979 — 1984
BS, Political Sciences
University of Belgrade 1979 — 1984
Bachelors, Political Science and Government
Jon Corona's Terumo Heart, Inc Experience September 2008 - May 2011
Job Sales Executive at IHS Automotive Driven by Polk
Industry Automotive
Experience
IHS Automotive - Driven by Polk December 2013 - Present
THI Corp July 2011 - September 2013
Terumo Heart Inc September 2008 - May 2011
Air International Thermal Systems 2003 - 2008
General Motors May 1997 - 2003
Skills
Automotive, Lean Manufacturing, Continuous Improvement, Purchasing, Manufacturing, Supply Management, Kaizen, Forecasting, Sourcing, Strategic Sourcing, Supply Chain Management, Negotiation, Product Development, Cross-functional Team..., New Business Development
Education
Michigan State University 1993 — 1997
BA, Materials and Logistics Management
Oakland University 1998 — 2000
MBA, Finance
IHS Automotive - Driven by Polk December 2013 - Present
THI Corp July 2011 - September 2013
Terumo Heart Inc September 2008 - May 2011
Air International Thermal Systems 2003 - 2008
General Motors May 1997 - 2003
Skills
Automotive, Lean Manufacturing, Continuous Improvement, Purchasing, Manufacturing, Supply Management, Kaizen, Forecasting, Sourcing, Strategic Sourcing, Supply Chain Management, Negotiation, Product Development, Cross-functional Team..., New Business Development
Education
Michigan State University 1993 — 1997
BA, Materials and Logistics Management
Oakland University 1998 — 2000
MBA, Finance
Howard Holmes's Terumo Heart, Inc Experience March 2006 - Present
Job Quality Systems Auditor at Terumo Heart, Inc.
Industry Medical Devices
Experience
Terumo Heart, Inc. March 2006 - Present
Chem-Trend July 2000 - October 2005
Pall Corporation 1997 - 1999
Gelman Sciences 1980 - 1999
Gelman Sciences, Inc. 1980 - 1999
Gelman Sciences/Pall Corporation 1980 - 1999
Gelman Sciences, Inc. 1990 - 1997
Skills
Quality System, FDA, Medical Devices, ISO 13485, Validation, Design Control, Manufacturing, GMP, R&D, Product Development, Quality Assurance, Process Improvement, Lean Manufacturing, Capital Equipment, ISO 14971, Quality Auditing, Cross-functional Team..., ISO, Root Cause Analysis, FMEA, SPC
Education
Kalamazoo College 1972 — 1976
BA, Biology & Chemistry
Terumo Heart, Inc. March 2006 - Present
Chem-Trend July 2000 - October 2005
Pall Corporation 1997 - 1999
Gelman Sciences 1980 - 1999
Gelman Sciences, Inc. 1980 - 1999
Gelman Sciences/Pall Corporation 1980 - 1999
Gelman Sciences, Inc. 1990 - 1997
Skills
Quality System, FDA, Medical Devices, ISO 13485, Validation, Design Control, Manufacturing, GMP, R&D, Product Development, Quality Assurance, Process Improvement, Lean Manufacturing, Capital Equipment, ISO 14971, Quality Auditing, Cross-functional Team..., ISO, Root Cause Analysis, FMEA, SPC
Education
Kalamazoo College 1972 — 1976
BA, Biology & Chemistry
Monica Alexander's Terumo Heart, Inc Experience August 2005 - September 2006
Job Regulatory Management Associate at Terumo Cardiovascular Systems
Industry Medical Devices
Experience
Terumo Cardiovascular Systems July 2006 - November 2010
Terumo Cardiovascular Systems July 2006 - November 2010
Terumo Cardiovascular Systems July 2006 - September 2006
Terumo Heart, Inc August 2005 - September 2006
Terumo Heart, Inc 2005 - 2006
ADECCO/Deloitte Tax, LLP December 2004 - May 2005
Kelly Services/ESPN Productions October 2002 - February 2003
InterFirst Wholesale Mortgage Lending January 1998 - November 1999
Bagel Bagel, Inc July 1996 - May 1998
First Family Financial Services, Inc January 1994 - March 1995
Skills
FDA, Intellectual Property, Software Documentation, Training, Testing, R, CAPA, ISO 13485, Manufacturing, Validation, Six Sigma, R&D, Design Control, Root Cause Analysis
Education
Florida Agricultural and Mechanical University 1991 — 1998
BS, Agriculture, Business, Economics
Florida A&M University
Bachelor of Science, Agriculture Business/Economics
RAPS Online University
Terumo Cardiovascular Systems July 2006 - November 2010
Terumo Cardiovascular Systems July 2006 - November 2010
Terumo Cardiovascular Systems July 2006 - September 2006
Terumo Heart, Inc August 2005 - September 2006
Terumo Heart, Inc 2005 - 2006
ADECCO/Deloitte Tax, LLP December 2004 - May 2005
Kelly Services/ESPN Productions October 2002 - February 2003
InterFirst Wholesale Mortgage Lending January 1998 - November 1999
Bagel Bagel, Inc July 1996 - May 1998
First Family Financial Services, Inc January 1994 - March 1995
Skills
FDA, Intellectual Property, Software Documentation, Training, Testing, R, CAPA, ISO 13485, Manufacturing, Validation, Six Sigma, R&D, Design Control, Root Cause Analysis
Education
Florida Agricultural and Mechanical University 1991 — 1998
BS, Agriculture, Business, Economics
Florida A&M University
Bachelor of Science, Agriculture Business/Economics
RAPS Online University
Howard Holmes's Terumo Heart, Inc Experience 2007 - 2011
Job Quality Engineer at Orchid Orthopedic Solutions
Industry Medical Devices
Experience
Orchid Orthopedic Solutions August 2013 - Present
Terumo Heart June 2011 - July 2013
Terumo Heart, INC 2007 - 2011
at TCVS March 2006 - June 2007
Chem-Trend Inc January 2000 - September 2005
Pall Corporation January 1998 - January 1999
Pall Corp. January 1997 - January 1998
Gelman Sciences January 1991 - January 1997
Gelman Sciences January 1985 - January 1991
Gelman Sciences January 1980 - January 1985
Skills
Technical Writing, Process Mapping, Quality Auditing, ISO 13485, FDA, Medical Devices, Quality System, CAPA, Validation, GMP, Supplier Quality, Quality Management, GDP, MSDS, Quality Assurance, Manufacturing, Process Improvement, Continuous Improvement, Capital Equipment, Quality Control, R&D, Software Documentation, Testing, ISO 14971, Regulatory Affairs, Design Control, 21 CFR, Process Simulation, ISO, Change Control, 21 CFR Part 11, Root Cause Analysis, SPC, FMEA
Education
Kalamazoo College
BA, Biology, Chemistry
Orchid Orthopedic Solutions August 2013 - Present
Terumo Heart June 2011 - July 2013
Terumo Heart, INC 2007 - 2011
at TCVS March 2006 - June 2007
Chem-Trend Inc January 2000 - September 2005
Pall Corporation January 1998 - January 1999
Pall Corp. January 1997 - January 1998
Gelman Sciences January 1991 - January 1997
Gelman Sciences January 1985 - January 1991
Gelman Sciences January 1980 - January 1985
Skills
Technical Writing, Process Mapping, Quality Auditing, ISO 13485, FDA, Medical Devices, Quality System, CAPA, Validation, GMP, Supplier Quality, Quality Management, GDP, MSDS, Quality Assurance, Manufacturing, Process Improvement, Continuous Improvement, Capital Equipment, Quality Control, R&D, Software Documentation, Testing, ISO 14971, Regulatory Affairs, Design Control, 21 CFR, Process Simulation, ISO, Change Control, 21 CFR Part 11, Root Cause Analysis, SPC, FMEA
Education
Kalamazoo College
BA, Biology, Chemistry
Thomas McKee, MSPA's Terumo Heart, Inc Experience May 2011 - September 2013
Job Manufacturing Engineering Cost Analyst at TriMotive Americas
Industry Accounting
Experience
TriMotive Americas November 2014 - Present
Delta Research Corporation November 2013 - May 2014
Terumo Heart, Inc. May 2011 - September 2013
Stevens Design Services 2009 - 2010
Creative Technology Services November 2006 - November 2008
Metaldyne Tubular 2005 - 2006
Moeller Manufacturing 2002 - 2004
Detroit Gauge & Tool / L.E. McKee 1987 - 2002
Skills
Manufacturing, Machine Tools, Medical Devices, Product Development, Automotive, Aerospace, Forecasting, Machinery, Welding, Electronics, Business Development, Business Strategy, Project Estimation, Information Systems, Budgets, Cost Reduction..., Fixture Design, Gauges, Program Management, Unigraphics, SolidWorks, PTC Pro/Engineer, Operational Cost..., Cost Engineering, Cost Variance Analysis, Cost Accounting, Continuous Improvement
Education
Walsh College 1995 — 1999
MSPA, Accounting
Lawrence Technological University 1984 — 1987
BSBA, Marketing
Central Michigan University 1982 — 1984
Accounting
TriMotive Americas November 2014 - Present
Delta Research Corporation November 2013 - May 2014
Terumo Heart, Inc. May 2011 - September 2013
Stevens Design Services 2009 - 2010
Creative Technology Services November 2006 - November 2008
Metaldyne Tubular 2005 - 2006
Moeller Manufacturing 2002 - 2004
Detroit Gauge & Tool / L.E. McKee 1987 - 2002
Skills
Manufacturing, Machine Tools, Medical Devices, Product Development, Automotive, Aerospace, Forecasting, Machinery, Welding, Electronics, Business Development, Business Strategy, Project Estimation, Information Systems, Budgets, Cost Reduction..., Fixture Design, Gauges, Program Management, Unigraphics, SolidWorks, PTC Pro/Engineer, Operational Cost..., Cost Engineering, Cost Variance Analysis, Cost Accounting, Continuous Improvement
Education
Walsh College 1995 — 1999
MSPA, Accounting
Lawrence Technological University 1984 — 1987
BSBA, Marketing
Central Michigan University 1982 — 1984
Accounting
Imran Moton's Terumo Heart, Inc Experience November 2007 - February 2012
Job Project Lead: PLT Integration at Baker Hughes
Industry Oil & Energy
Experience
Baker Hughes June 2013 - Present
Baker Hughes February 2012 - June 2014
Terumo Heart Inc. November 2007 - February 2012
General Motors 1995 - 2007
Skills
ISO 13485, Medical Devices, FMEA, Design Control, R&D, Electronics, Biomedical Engineering, Embedded Systems, FDA, Engineering, Manufacturing, Labview, Product Development, Testing, Quality System, Root Cause Analysis, Engineering Management
Education
University of California, Berkeley 1994 — 1996
Master of Science (MS), Nuclear Engineering
University of California, Berkeley 1992 — 1994
Bachelors of Science, Electronics Engineering and Computer Science & Nuclear Engineering
Baker Hughes June 2013 - Present
Baker Hughes February 2012 - June 2014
Terumo Heart Inc. November 2007 - February 2012
General Motors 1995 - 2007
Skills
ISO 13485, Medical Devices, FMEA, Design Control, R&D, Electronics, Biomedical Engineering, Embedded Systems, FDA, Engineering, Manufacturing, Labview, Product Development, Testing, Quality System, Root Cause Analysis, Engineering Management
Education
University of California, Berkeley 1994 — 1996
Master of Science (MS), Nuclear Engineering
University of California, Berkeley 1992 — 1994
Bachelors of Science, Electronics Engineering and Computer Science & Nuclear Engineering
Evan Lampe's Terumo Heart, Inc Experience June 2008 - August 2008
Job Mechanical Engineer at GE Healthcare
Industry Mechanical or Industrial Engineering
Experience
GE Healthcare August 2012 - Present
GE Healthcare July 2010 - August 2012
Natick Soldier Center June 2009 - August 2009
Terumo Heart Inc. June 2008 - August 2008
Cooper Power Systems June 2007 - August 2007
Education
Massachusetts Institute of Technology 2006 — 2010
BS, Mechanical Engineering
GE Healthcare August 2012 - Present
GE Healthcare July 2010 - August 2012
Natick Soldier Center June 2009 - August 2009
Terumo Heart Inc. June 2008 - August 2008
Cooper Power Systems June 2007 - August 2007
Education
Massachusetts Institute of Technology 2006 — 2010
BS, Mechanical Engineering
Jennifer Skwarski's Terumo Heart, Inc Experience May 2010 - Present
Job Quality Assurance Technician at Terumo Heart
Industry Medical Devices
Experience
Terumo Heart, Inc. May 2010 - Present
FCI Automotive August 1992 - January 2010
Education
Michigan Technological University 1987 — 1992
AAS & BA, Electrical Engineering Technology & Interdisciplinary Liberal Arts
Terumo Heart, Inc. May 2010 - Present
FCI Automotive August 1992 - January 2010
Education
Michigan Technological University 1987 — 1992
AAS & BA, Electrical Engineering Technology & Interdisciplinary Liberal Arts
Jerry Lan's Terumo Heart, Inc Experience September 2012 - July 2013
Job Product Engineer at Griswold Engineering, Inc.
Industry Mechanical or Industrial Engineering
Experience
Griswold Engineering, Inc. May 2008 - Present
Terumo Heart, Inc. September 2012 - July 2013
Detroit International Auto Salon, Inc. May 2009 - September 2009
Navistar International Truck and Engine Corporation June 2007 - August 2007
Army Academy R.O.C. October 2003 - May 2005
Skills
Catia, Solidworks, Matlab, Simulink, AutoCAD, Product Development, Product Management, Automotive, Engineering, Product Design
Education
University of Michigan 2006 — 2007
Master of Science, Mechanical Engineering
National Tsing Hua University 1999 — 2003
Bachelor of Science, Power Mechanical Engineering
SS High School
Griswold Engineering, Inc. May 2008 - Present
Terumo Heart, Inc. September 2012 - July 2013
Detroit International Auto Salon, Inc. May 2009 - September 2009
Navistar International Truck and Engine Corporation June 2007 - August 2007
Army Academy R.O.C. October 2003 - May 2005
Skills
Catia, Solidworks, Matlab, Simulink, AutoCAD, Product Development, Product Management, Automotive, Engineering, Product Design
Education
University of Michigan 2006 — 2007
Master of Science, Mechanical Engineering
National Tsing Hua University 1999 — 2003
Bachelor of Science, Power Mechanical Engineering
SS High School
Tamie OGrady's Terumo Heart, Inc Experience January 2012 - Present
Job Program Coordinator at Terumo Heart, Inc.
Industry Medical Devices
Experience
Terumo Heart, Inc. January 2012 - Present
Nichia America Corporation July 2011 - February 2012
Lingua Science - Toyota Technical Center December 2007 - June 2011
Caterpillar Inc. 2003 - 2007
Education
Meiji Gakuin University 1993 — 1997
Bachelor of Art, International Study
Terumo Heart, Inc. January 2012 - Present
Nichia America Corporation July 2011 - February 2012
Lingua Science - Toyota Technical Center December 2007 - June 2011
Caterpillar Inc. 2003 - 2007
Education
Meiji Gakuin University 1993 — 1997
Bachelor of Art, International Study
Matt Kourtjian, MBA's Terumo Heart, Inc Experience May 2008 - May 2009
Job Regional HR Manager/Organizational Development Manager at Absopure Water Company
Industry Food & Beverages
Experience
Absopure Water Company August 2014 - Present
Absopure Water Company August 2013 - August 2014
Absopure Water Company January 2012 - August 2013
Absopure Water Company June 2010 - January 2012
Dawn Food Products July 2009 - June 2010
Allegiance Health May 2009 - July 2009
Terumo Heart Inc May 2008 - May 2009
B&B Hardware August 2007 - May 2008
Skills
Employee Relations, HRIS, Recruiting, Deferred Compensation, Benefits Administration, Human Resources, Employment Law, DOT regulations, Payroll, Compensation & Benefit, Training, Career Development, Organizational..., Organizational Design, College Recruiting, Temporary Placement, Sourcing, Leave of Absence, Performance Management, SAP, Team Building, FMLA, Performance Appraisal, Interviews, Employee Handbooks, HR Policies, Employee Benefits, Exit Interviews, Talent Management, Talent Acquisition, SAP HR, Succession Planning, Open Enrollment, Background Checks, Onboarding, Labor Relations, Personnel Management, Leadership Development, Resume Writing, Job Fairs, Job Descriptions, Policy, Applicant Tracking..., Kronos, Employee Engagement, Job Evaluation, Conflict Resolution, New Hire Orientations, Salary, Hiring
Education
Eastern Michigan University
MBA, Human Resource Management
Eastern Michigan University
Master's Certificate, Organizational Development
Baker College
BBA, Management; Human Resource Management
Absopure Water Company August 2014 - Present
Absopure Water Company August 2013 - August 2014
Absopure Water Company January 2012 - August 2013
Absopure Water Company June 2010 - January 2012
Dawn Food Products July 2009 - June 2010
Allegiance Health May 2009 - July 2009
Terumo Heart Inc May 2008 - May 2009
B&B Hardware August 2007 - May 2008
Skills
Employee Relations, HRIS, Recruiting, Deferred Compensation, Benefits Administration, Human Resources, Employment Law, DOT regulations, Payroll, Compensation & Benefit, Training, Career Development, Organizational..., Organizational Design, College Recruiting, Temporary Placement, Sourcing, Leave of Absence, Performance Management, SAP, Team Building, FMLA, Performance Appraisal, Interviews, Employee Handbooks, HR Policies, Employee Benefits, Exit Interviews, Talent Management, Talent Acquisition, SAP HR, Succession Planning, Open Enrollment, Background Checks, Onboarding, Labor Relations, Personnel Management, Leadership Development, Resume Writing, Job Fairs, Job Descriptions, Policy, Applicant Tracking..., Kronos, Employee Engagement, Job Evaluation, Conflict Resolution, New Hire Orientations, Salary, Hiring
Education
Eastern Michigan University
MBA, Human Resource Management
Eastern Michigan University
Master's Certificate, Organizational Development
Baker College
BBA, Management; Human Resource Management
Dennis Graber's Terumo Heart, Inc Experience September 2012 - July 2013
Job Supply Chain Manager at Thoratec
Industry Medical Devices
Experience
Thoratec July 2013 - Present
Terumo Heart Inc September 2012 - July 2013
Terumo Heart Inc. July 2011 - September 2012
JHP Pharmaceuticals LLC October 2007 - December 2010
King Pharmaceuticals September 2000 - October 2007
King Pharmaceuticals February 1999 - September 2000
Warner Lambert (Pfizer) March 1995 - February 1999
Skills
ASQ CQA certified, Quality Assurance, Quality System, GMP, FDA, ISO, Supply Chain, Risk Management, Supplier Quality, Product Management, CAPA, Validation, V&V, Medical Devices, 21 CFR Part 11, Change Control, Sop, Pharmaceutical Industry, ISO 13485, Quality Auditing
Education
Michigan State University
N/A, General courses
Oakland University
BA, Biology
Walsh College of Accountancy and Business Administration
Masters of Science, Management
Thoratec July 2013 - Present
Terumo Heart Inc September 2012 - July 2013
Terumo Heart Inc. July 2011 - September 2012
JHP Pharmaceuticals LLC October 2007 - December 2010
King Pharmaceuticals September 2000 - October 2007
King Pharmaceuticals February 1999 - September 2000
Warner Lambert (Pfizer) March 1995 - February 1999
Skills
ASQ CQA certified, Quality Assurance, Quality System, GMP, FDA, ISO, Supply Chain, Risk Management, Supplier Quality, Product Management, CAPA, Validation, V&V, Medical Devices, 21 CFR Part 11, Change Control, Sop, Pharmaceutical Industry, ISO 13485, Quality Auditing
Education
Michigan State University
N/A, General courses
Oakland University
BA, Biology
Walsh College of Accountancy and Business Administration
Masters of Science, Management
Daniel Guyon's Terumo Heart, Inc Experience May 2005 - July 2008
Job RF Microelectronics Engineer
Industry Defense & Space
Experience
Draper Laboratory January 2015 - Present
Draper Laboratory November 2010 - December 2014
Georgia Tech ECE department August 2009 - November 2010
Georgia Institute of Technology August 2008 - August 2009
Terumo Heart, Inc. May 2005 - July 2008
Skills
Cadence Virtuoso, Agilent ADS, RF design, Analog Circuit Design, Matlab, Python, C/C++, Control System Design, millimeter wave..., Verilog-A, Control Systems Design, Electronics, IC, Sensors, PCB design, Testing, RF, Microelectronics, PCB Design
Education
Georgia Institute of Technology 2008 — 2009
MSECE, Electrical Engineering
Michigan State University 2003 — 2007
BS, Electrical Engineering
Draper Laboratory January 2015 - Present
Draper Laboratory November 2010 - December 2014
Georgia Tech ECE department August 2009 - November 2010
Georgia Institute of Technology August 2008 - August 2009
Terumo Heart, Inc. May 2005 - July 2008
Skills
Cadence Virtuoso, Agilent ADS, RF design, Analog Circuit Design, Matlab, Python, C/C++, Control System Design, millimeter wave..., Verilog-A, Control Systems Design, Electronics, IC, Sensors, PCB design, Testing, RF, Microelectronics, PCB Design
Education
Georgia Institute of Technology 2008 — 2009
MSECE, Electrical Engineering
Michigan State University 2003 — 2007
BS, Electrical Engineering
Bryana Jones's Terumo Heart, Inc Experience October 2007 - September 2013
Job Sr. Test Engineer for Stryker Instruments
Industry Medical Devices
Experience
Stryker March 2014 - Present
Terumo Heart Inc October 2007 - September 2013
Skills
Testing, Design for Manufacturing, Engineering, Design Control, SolidWorks, Medical Devices, ISO 13485, R, Geometric Dimensioning
Education
Baker College of Jackson 2012 — 2017
Bachelor of Engineering (BE), electrical/mechanical engineering
ITT Technical Institute-Troy 2000 — 2002
Associate of Science (AS), computer aided drafting
Stryker March 2014 - Present
Terumo Heart Inc October 2007 - September 2013
Skills
Testing, Design for Manufacturing, Engineering, Design Control, SolidWorks, Medical Devices, ISO 13485, R, Geometric Dimensioning
Education
Baker College of Jackson 2012 — 2017
Bachelor of Engineering (BE), electrical/mechanical engineering
ITT Technical Institute-Troy 2000 — 2002
Associate of Science (AS), computer aided drafting
Carl Engling's Terumo Heart, Inc Experience February 2007 - July 2013
Job Manufacturing Engineer/Machine Programmer at Thoratec
Industry Medical Devices
Experience
Thoratec July 2013 - Present
Terumo Heart Inc February 2007 - July 2013
Molded Materials April 2000 - April 2007
Skills
Machining, Manufacturing, CNC, CAD/CAM, Medical Devices, Manufacturing..., ISO 13485, Lean Manufacturing, Continuous Improvement, Root Cause Analysis, FMEA, Six Sigma, Design for Manufacturing, Product Development
Education
Schoolcraft College 2009 — 2015
Associate's degree, Advance Manufacturing
Thoratec July 2013 - Present
Terumo Heart Inc February 2007 - July 2013
Molded Materials April 2000 - April 2007
Skills
Machining, Manufacturing, CNC, CAD/CAM, Medical Devices, Manufacturing..., ISO 13485, Lean Manufacturing, Continuous Improvement, Root Cause Analysis, FMEA, Six Sigma, Design for Manufacturing, Product Development
Education
Schoolcraft College 2009 — 2015
Associate's degree, Advance Manufacturing
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