Medical Device Consulting
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Medical Device Consulting Employees
Employee
Years
Job
Industry
David Van Voorhis David Van Voorhis's Medical Device Consulting Experience January 2009 - Present
Job Principal Consultant
Industry Medical Devices
Experience
Medical Device Consulting January 2009 - Present
Bausch & Lomb August 2005 - January 2009
STAAR Surgical February 1992 - February 2005
Optical Radiation Corp July 1988 - December 1991
Surgidev Corporation 1985 - 1988
Cox Uphoff International 1984 - 1985
American Heyer-Schulte September 1981 - April 1984
Eastman Kodak Company 1973 - 1977
Skills
Medical Devices, Ophthalmology, Surgeons, Clinical Research, Surgical Instruments, Capital Equipment, Surgery, Product Development, Disposables, Market Development, Sales, R&D, Pharmaceutical Sales, FDA, Digital Imaging, Medicine, Design Control, Product Launch, Orthopedic, Operating Room, Hardware Diagnostics, ISO 13485, Biomedical Engineering, Biotechnology, Product Management, Medical Imaging, Healthcare, Cardiology, Clinical Trials, Vascular, Commercialization, Urology, CAPA, Interventional Radiology, Validation, Global Marketing, V&V, Hospitals
Education
State University of New York College at Oswego 1977 — 1980
BA, Zoology/Physiology/Computer Science
Medical Device Consulting January 2009 - Present
Bausch & Lomb August 2005 - January 2009
STAAR Surgical February 1992 - February 2005
Optical Radiation Corp July 1988 - December 1991
Surgidev Corporation 1985 - 1988
Cox Uphoff International 1984 - 1985
American Heyer-Schulte September 1981 - April 1984
Eastman Kodak Company 1973 - 1977
Skills
Medical Devices, Ophthalmology, Surgeons, Clinical Research, Surgical Instruments, Capital Equipment, Surgery, Product Development, Disposables, Market Development, Sales, R&D, Pharmaceutical Sales, FDA, Digital Imaging, Medicine, Design Control, Product Launch, Orthopedic, Operating Room, Hardware Diagnostics, ISO 13485, Biomedical Engineering, Biotechnology, Product Management, Medical Imaging, Healthcare, Cardiology, Clinical Trials, Vascular, Commercialization, Urology, CAPA, Interventional Radiology, Validation, Global Marketing, V&V, Hospitals
Education
State University of New York College at Oswego 1977 — 1980
BA, Zoology/Physiology/Computer Science
Brian Goold Brian Goold's Medical Device Consulting Experience February 2011 - March 2014
Job National Sales Manager Alternate Care, HTLStrefa, Inc.
Industry Medical Devices
Experience
HTL-Strefa, Inc. May 2015 - Present
Burlington Medical Supplies April 2014 - April 2015
Medical Device Consulting February 2011 - March 2014
UpToDate Inc. January 2009 - April 2010
Hill-Rom December 2006 - November 2008
Coloplast Corp August 2001 - November 2006
Coloplast Corp October 1996 - July 2001
Skills
Team Building, Developing people, Navigating complex..., Performance management, Building business..., P&L Responsibility, Driving clinician..., Hospital Sales, Physician Practice sales, Woundcare, Ostomy,..., Strategies and Tactics, Competing as small..., Expense Management, Patient Referral..., Contracting with IDN, ..., Chronic patient..., Patient retention,..., Hospitals, Performance Management, Sales, Building Business..., Sales Management, Sales Operations, Healthcare, Preferences
Education
McGill University
MBA
HTL-Strefa, Inc. May 2015 - Present
Burlington Medical Supplies April 2014 - April 2015
Medical Device Consulting February 2011 - March 2014
UpToDate Inc. January 2009 - April 2010
Hill-Rom December 2006 - November 2008
Coloplast Corp August 2001 - November 2006
Coloplast Corp October 1996 - July 2001
Skills
Team Building, Developing people, Navigating complex..., Performance management, Building business..., P&L Responsibility, Driving clinician..., Hospital Sales, Physician Practice sales, Woundcare, Ostomy,..., Strategies and Tactics, Competing as small..., Expense Management, Patient Referral..., Contracting with IDN, ..., Chronic patient..., Patient retention,..., Hospitals, Performance Management, Sales, Building Business..., Sales Management, Sales Operations, Healthcare, Preferences
Education
McGill University
MBA
A. Thomas Iliadis, CQE A. Thomas Iliadis, CQE's Medical Device Consulting Experience 2000 - Present
Job Quality and Engineering Consulting
Industry Medical Devices
Experience
Medical Device Consulting 2000 - Present
Integra LifeSciences 2011 - 2012
Philips Healthcare, Imaging Systems 2011 - 2011
Johnson & Johnson (Ethicon Ventures Group) 2010 - 2011
Becton, Dickinson and Company 2009 - 2010
Johnson & Johnson (Ethicon) 2008 - 2009
Teleflex Medical 2008 - 2008
BioHorizons 2008 - 2008
Philips (Respironics) 2007 - 2007
Lavipharm 2005 - 2006
Skills
Process Validation, CAPA, QSR, Validation Management, Process Development, Project Management, Technology Transfer, Quality Systems, ISO 13485, ISO 14971, Design of Experiments, Risk Analysis, Process Control, Design Control, Risk Management, Validation, GMP, Compliance, ISO, Manufacturing, Quality Engineering, FDA, cGMP, DOE, SOP, Process Improvement, Root Cause Analysis, Supplier Quality, Quality System, Sop, Six Sigma, V&V, Quality Control, Process Simulation, Biopharmaceuticals, Biotechnology, R&D, Product Development, Medical Devices, Engineering, Pharmaceutical Industry, Process Engineering, DMAIC, Biomedical Engineering, Quality Assurance, Commercialization, GAMP, GxP, Change Control, Product Launch
Education
Stevens Institute of Technology 1993 — 1996
Masters, Technology Management
Stevens Institute of Technology 1976 — 1980
Bachelors, Chemical Engineering
Freehold High School
Medical Device Consulting 2000 - Present
Integra LifeSciences 2011 - 2012
Philips Healthcare, Imaging Systems 2011 - 2011
Johnson & Johnson (Ethicon Ventures Group) 2010 - 2011
Becton, Dickinson and Company 2009 - 2010
Johnson & Johnson (Ethicon) 2008 - 2009
Teleflex Medical 2008 - 2008
BioHorizons 2008 - 2008
Philips (Respironics) 2007 - 2007
Lavipharm 2005 - 2006
Skills
Process Validation, CAPA, QSR, Validation Management, Process Development, Project Management, Technology Transfer, Quality Systems, ISO 13485, ISO 14971, Design of Experiments, Risk Analysis, Process Control, Design Control, Risk Management, Validation, GMP, Compliance, ISO, Manufacturing, Quality Engineering, FDA, cGMP, DOE, SOP, Process Improvement, Root Cause Analysis, Supplier Quality, Quality System, Sop, Six Sigma, V&V, Quality Control, Process Simulation, Biopharmaceuticals, Biotechnology, R&D, Product Development, Medical Devices, Engineering, Pharmaceutical Industry, Process Engineering, DMAIC, Biomedical Engineering, Quality Assurance, Commercialization, GAMP, GxP, Change Control, Product Launch
Education
Stevens Institute of Technology 1993 — 1996
Masters, Technology Management
Stevens Institute of Technology 1976 — 1980
Bachelors, Chemical Engineering
Freehold High School
Larry Wissman Larry Wissman's Medical Device Consulting Experience January 2013 - Present
Job Medical device professional, proven track record, successful product and process development, new product introductions.
Industry Medical Devices
Experience
Medical Device Consulting January 2013 - Present
Ethicon Inc., a Johnson & Johnson company October 2010 - December 2012
Ethicon Inc., a Johnson & Johnson company August 2011 - June 2012
Mentor Worldwide, LLC, a Johnson & Johnson Company 2006 - October 2010
Mentor Corporation 2000 - 2006
Mentor Corporation 1997 - 2000
Mentor Corporation 1993 - 1997
CoastVision, Inc. 1991 - 1993
Mentor Corporation 1989 - 1991
Independent Technical Consulting Business 1986 - 1989
Skills
Biomedical Engineering, Quality Assurance, ISO 13485, Quality System, Operating Room, V&V, Global Marketing, Pharmaceutical Industry, Product Development, Medical Devices, Design Control, Capital Equipment, Product Launch, CAPA, FDA
Education
Union College
Medical Device Consulting January 2013 - Present
Ethicon Inc., a Johnson & Johnson company October 2010 - December 2012
Ethicon Inc., a Johnson & Johnson company August 2011 - June 2012
Mentor Worldwide, LLC, a Johnson & Johnson Company 2006 - October 2010
Mentor Corporation 2000 - 2006
Mentor Corporation 1997 - 2000
Mentor Corporation 1993 - 1997
CoastVision, Inc. 1991 - 1993
Mentor Corporation 1989 - 1991
Independent Technical Consulting Business 1986 - 1989
Skills
Biomedical Engineering, Quality Assurance, ISO 13485, Quality System, Operating Room, V&V, Global Marketing, Pharmaceutical Industry, Product Development, Medical Devices, Design Control, Capital Equipment, Product Launch, CAPA, FDA
Education
Union College
Bill Konopisos Bill Konopisos's Medical Device Consulting Experience July 2007 - Present
Job
Industry Medical Devices
Experience
Foundling Medical June 2010 - Present
Medical Device Consulting July 2007 - Present
CyberMedix Medical Systems, LLC. February 2012 - July 2013
Biosensors International March 2005 - July 2007
Cambridge Heart 2004 - 2005
I-Flow Corporation 2001 - 2002
Biosense Webster 1997 - 2000
Mallinckrodt Medical 1993 - 1997
Shiley Inc 1988 - 1993
Skills
Medical Devices, Product Launch, Market Development, Healthcare, Hospitals, Start-ups, Product Development, Sales Management, Leadership, Management, Surgeons, Capital Equipment, Commercialization, Medical Imaging, Manufacturing, Operating Room, Biotechnology, Business Strategy, FDA, Cardiology, Hardware Diagnostics, Interventional..., Disposables, Urology, Clinical, Marketing, New Business Development, Global Marketing, Clinical Trials, Orthopedic, Strategy, Cross-functional Team..., Clinical Research, Sales, Surgical Instruments, ISO 13485, Surgery, Vascular, Sales Force Development
Education
National University
MBA Studies
University of Wyoming
BA, English
Foundling Medical June 2010 - Present
Medical Device Consulting July 2007 - Present
CyberMedix Medical Systems, LLC. February 2012 - July 2013
Biosensors International March 2005 - July 2007
Cambridge Heart 2004 - 2005
I-Flow Corporation 2001 - 2002
Biosense Webster 1997 - 2000
Mallinckrodt Medical 1993 - 1997
Shiley Inc 1988 - 1993
Skills
Medical Devices, Product Launch, Market Development, Healthcare, Hospitals, Start-ups, Product Development, Sales Management, Leadership, Management, Surgeons, Capital Equipment, Commercialization, Medical Imaging, Manufacturing, Operating Room, Biotechnology, Business Strategy, FDA, Cardiology, Hardware Diagnostics, Interventional..., Disposables, Urology, Clinical, Marketing, New Business Development, Global Marketing, Clinical Trials, Orthopedic, Strategy, Cross-functional Team..., Clinical Research, Sales, Surgical Instruments, ISO 13485, Surgery, Vascular, Sales Force Development
Education
National University
MBA Studies
University of Wyoming
BA, English
Phil Ankeny's Medical Device Consulting Experience September 2011 - March 2013
Job CFO at Minnetronix, Inc.
Industry Medical Devices
Experience
Minnetronix, Inc. April 2013 - Present
Medical Device Consulting September 2011 - March 2013
SurModics 2003 - August 2011
Cognicity 1999 - 2002
Sherpa Partners 1998 - 1999
Robertson Stephens 1994 - 1997
Shiva Corporation 1994 - 1994
IBM Corporation 1989 - 1994
Morgan Stanley & Co. 1985 - 1987
Education
Harvard Business School 1987 — 1989
MBA
Dartmouth College 1981 — 1985
A.B., Economics and Engineering
Minnetronix, Inc. April 2013 - Present
Medical Device Consulting September 2011 - March 2013
SurModics 2003 - August 2011
Cognicity 1999 - 2002
Sherpa Partners 1998 - 1999
Robertson Stephens 1994 - 1997
Shiva Corporation 1994 - 1994
IBM Corporation 1989 - 1994
Morgan Stanley & Co. 1985 - 1987
Education
Harvard Business School 1987 — 1989
MBA
Dartmouth College 1981 — 1985
A.B., Economics and Engineering
Trevor Bieber Trevor Bieber's Medical Device Consulting Experience May 2015 - Present
Job Experienced medical device consultant
Industry Medical Devices
Experience
Medical Device Consulting May 2015 - Present
Vascular Solutions March 2008 - May 2015
Vascular Solutions May 2007 - March 2008
Pace Analytical 2005 - 2007
Ecolab 2003 - 2005
3M 2000 - 2002
Skills
Validation, GMP, Medical Devices, Analytical Chemistry, HPLC, Quality System, Quality Assurance, R&D, Chemistry, Sop, UV/Vis, Quality Control, Gas Chromatography, Product Development, Biomaterials, FDA, ISO 13485, Characterization, Lifesciences, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Endovascular, Hemostasis, Improved Clinical..., Reduced Costs, Cost-Effectiveness..., Combination Products, Embolization, Formulation, Coatings, Solid Dosage Forms, Percutaneous, Process Development, Biodegradable Polymers, V&V, Laboratory, Hydrogel, Manufacturing, CAPA, Management
Education
Stanford University 2010 — 2012
University of Minnesota-Twin Cities 1999 — 2003
BA
The University of North Dakota 1997 — 1999
Medical Device Consulting May 2015 - Present
Vascular Solutions March 2008 - May 2015
Vascular Solutions May 2007 - March 2008
Pace Analytical 2005 - 2007
Ecolab 2003 - 2005
3M 2000 - 2002
Skills
Validation, GMP, Medical Devices, Analytical Chemistry, HPLC, Quality System, Quality Assurance, R&D, Chemistry, Sop, UV/Vis, Quality Control, Gas Chromatography, Product Development, Biomaterials, FDA, ISO 13485, Characterization, Lifesciences, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Endovascular, Hemostasis, Improved Clinical..., Reduced Costs, Cost-Effectiveness..., Combination Products, Embolization, Formulation, Coatings, Solid Dosage Forms, Percutaneous, Process Development, Biodegradable Polymers, V&V, Laboratory, Hydrogel, Manufacturing, CAPA, Management
Education
Stanford University 2010 — 2012
University of Minnesota-Twin Cities 1999 — 2003
BA
The University of North Dakota 1997 — 1999
Larry Heaton Larry Heaton's Medical Device Consulting Experience August 2009 - April 2010
Job President & CEO at Cardiox Corporation
Industry Medical Devices
Experience
CardiOx Corp April 2010 - Present
Medical Device Consulting August 2009 - April 2010
ViOptix, Inc. April 2007 - July 2009
Curon Medical January 2003 - November 2006
Response Genetics August 2000 - December 2002
United States Surgical Corporation April 1982 - May 2000
Skills
Start-ups, Sales Management, Business Strategy, Strategic Planning, Product Development, Mergers, Marketing Strategy, New Business Development, Team Building, Biotechnology, Executive Management, Commercialization, Strategy Development, P&L Management, Healthcare, Diagnostics, Market Development, Organizational..., Management Consulting, International Business, Change Management, Negotiation, Strategic Business, Entrepreneurship, Contract Negotiation, Joint Ventures, Budgeting, Fundraising, Leadership Development, Corporate Development, Market Penetration, Operational Excellence, Process Improvement, Small Business, Public Speaking, Due Diligence, Medical Devices, Venture Capital, Business Planning, Product Management, Restructuring, Strategic Partnerships, Product Marketing, Product Launch, Cross-functional Team..., Capital Equipment, Leadership, Disposables, FDA, Global Marketing
Education
University of Illinois at Urbana-Champaign 1977 — 1979
Business Administration
University of Illinois at Urbana-Champaign 1977 — 1979
Business Administration
Eastern Illinois University 1974 — 1977
Political Science
Rantoul Township High School 1970 — 1975
High School Diploma
CardiOx Corp April 2010 - Present
Medical Device Consulting August 2009 - April 2010
ViOptix, Inc. April 2007 - July 2009
Curon Medical January 2003 - November 2006
Response Genetics August 2000 - December 2002
United States Surgical Corporation April 1982 - May 2000
Skills
Start-ups, Sales Management, Business Strategy, Strategic Planning, Product Development, Mergers, Marketing Strategy, New Business Development, Team Building, Biotechnology, Executive Management, Commercialization, Strategy Development, P&L Management, Healthcare, Diagnostics, Market Development, Organizational..., Management Consulting, International Business, Change Management, Negotiation, Strategic Business, Entrepreneurship, Contract Negotiation, Joint Ventures, Budgeting, Fundraising, Leadership Development, Corporate Development, Market Penetration, Operational Excellence, Process Improvement, Small Business, Public Speaking, Due Diligence, Medical Devices, Venture Capital, Business Planning, Product Management, Restructuring, Strategic Partnerships, Product Marketing, Product Launch, Cross-functional Team..., Capital Equipment, Leadership, Disposables, FDA, Global Marketing
Education
University of Illinois at Urbana-Champaign 1977 — 1979
Business Administration
University of Illinois at Urbana-Champaign 1977 — 1979
Business Administration
Eastern Illinois University 1974 — 1977
Political Science
Rantoul Township High School 1970 — 1975
High School Diploma
Sheila Heyer Sheila Heyer's Medical Device Consulting Experience January 1990 - June 1997
Job President at Heyer Regulatory Solutions, LLC
Industry Medical Devices
Experience
Heyer Regulatory Solutions, LLC November 2010 - Present
Boston Scientific Corporation April 2005 - October 2010
Medical Device Consultants, Inc July 1998 - April 2005
Massachusetts Supreme Judicial Court July 1997 - June 1998
Medical Device Consulting January 1990 - June 1997
Food and Drug Administration March 1987 - December 1989
Skills
Global Regulatory..., PMA, 510(k), IDE, MDD, Technical Files, Design Dossiers, Canadian License..., QSR, ISO 13485, MDR, Recall, Clinical Study Design, Clinical Trials, Due Diligence, Medical Device Directive, Regulatory Submissions, Quality System, Regulatory Affairs, Design Control, FDA, Medical Devices, CAPA, Strategy, Commercialization, Biomedical Engineering, V&V, Regulatory Requirements, ISO 14971, 21 CFR Part 11, GMP, Clinical Development, Clinical Research, Biotechnology, Validation, Technology Transfer, R&D, Change Control
Education
Western New England College School of Law 1993 — 1997
JD, law
University of Massachusetts, Amherst 1984 — 1986
MS, Biomechanics
Boston University 1977 — 1981
BS, Biomedical Engineering
Heyer Regulatory Solutions, LLC November 2010 - Present
Boston Scientific Corporation April 2005 - October 2010
Medical Device Consultants, Inc July 1998 - April 2005
Massachusetts Supreme Judicial Court July 1997 - June 1998
Medical Device Consulting January 1990 - June 1997
Food and Drug Administration March 1987 - December 1989
Skills
Global Regulatory..., PMA, 510(k), IDE, MDD, Technical Files, Design Dossiers, Canadian License..., QSR, ISO 13485, MDR, Recall, Clinical Study Design, Clinical Trials, Due Diligence, Medical Device Directive, Regulatory Submissions, Quality System, Regulatory Affairs, Design Control, FDA, Medical Devices, CAPA, Strategy, Commercialization, Biomedical Engineering, V&V, Regulatory Requirements, ISO 14971, 21 CFR Part 11, GMP, Clinical Development, Clinical Research, Biotechnology, Validation, Technology Transfer, R&D, Change Control
Education
Western New England College School of Law 1993 — 1997
JD, law
University of Massachusetts, Amherst 1984 — 1986
MS, Biomechanics
Boston University 1977 — 1981
BS, Biomedical Engineering
Monique Riley Monique Riley's Medical Device Consulting Experience January 2011 - January 2012
Job Manufacturing Program Management Intern at Avid Technology
Industry Higher Education
Experience
Santa Clara Malley Fitness Center November 2014 - Present
Santa Clara Malley Fitness Center September 2014 - Present
Santa Clara University September 2012 - Present
Avid Technology June 2015 - September 2015
Singer/Musician, Studio Trilogy January 2013 - February 2014
Medical Device Consulting January 2011 - January 2012
OPEN HEART KITCHEN Food Bank January 2010 - January 2012
The First Tee of Pleasanton January 2010 - January 2012
LPGA-USGA Girl Golf Club January 2008 - January 2012
Skills
Collegiate Athlete, Singer-songwriter, Social Media, Film Production, Music, Music Production, Communication, Event Planning
Education
Amador Valley High School
Santa Clara University
Bachelor of Arts, Communication
Santa Clara University
Santa Clara Malley Fitness Center November 2014 - Present
Santa Clara Malley Fitness Center September 2014 - Present
Santa Clara University September 2012 - Present
Avid Technology June 2015 - September 2015
Singer/Musician, Studio Trilogy January 2013 - February 2014
Medical Device Consulting January 2011 - January 2012
OPEN HEART KITCHEN Food Bank January 2010 - January 2012
The First Tee of Pleasanton January 2010 - January 2012
LPGA-USGA Girl Golf Club January 2008 - January 2012
Skills
Collegiate Athlete, Singer-songwriter, Social Media, Film Production, Music, Music Production, Communication, Event Planning
Education
Amador Valley High School
Santa Clara University
Bachelor of Arts, Communication
Santa Clara University
Eric T. Dahl Eric T. Dahl's Medical Device Consulting Experience December 2002 - December 2003
Job Director, Real Estate Development at American Tower Corporation
Industry Telecommunications
Experience
American Tower Corporation September 2014 - Present
Ocular Therapeutix, Inc. February 2014 - September 2014
DePuy Synthes, Mitek Sports Medicine, a Johnson & Johnson Company January 2010 - January 2014
DePuy Mitek/ Johnson & Johnson March 2006 - January 2010
DePuy Mitek Inc. a Johnson & Johnson Company April 2005 - March 2006
NuVasive, Inc December 2003 - April 2005
Medical Device Consulting December 2002 - December 2003
Blackstone Medical Inc. September 2001 - December 2002
Focal Inc. October 1999 - August 2001
Focal Inc. July 1996 - October 1999
Skills
Brand Management, Medical Devices, Public Speaking, Product Launch, Strategy, Cross-functional Team..., Selling, Market Development, Market Planning, Vascular, Pharmaceutical Sales, Hospital Sales, ENT, Clinical Research, ISO 13485, Biotechnology, Managed Care, Lifesciences, Marketing Research, Interventional Radiology, Connecting People, Marketing Communications, Neurology, Pharmaceutical Industry, Management, Networking, P&L Management, International Marketing, Pricing, Professional Mentoring, Key Account Management, Competitive Intelligence, R&D, Oncology, Email Marketing, Capital Equipment, Sales, Sales Operations, Surgeons
Education
University of Denver - Daniels College of Business 1983 — 1985
BSBA, Marketing
Augsburg College 1979 — 1982
Psychology
American Tower Corporation September 2014 - Present
Ocular Therapeutix, Inc. February 2014 - September 2014
DePuy Synthes, Mitek Sports Medicine, a Johnson & Johnson Company January 2010 - January 2014
DePuy Mitek/ Johnson & Johnson March 2006 - January 2010
DePuy Mitek Inc. a Johnson & Johnson Company April 2005 - March 2006
NuVasive, Inc December 2003 - April 2005
Medical Device Consulting December 2002 - December 2003
Blackstone Medical Inc. September 2001 - December 2002
Focal Inc. October 1999 - August 2001
Focal Inc. July 1996 - October 1999
Skills
Brand Management, Medical Devices, Public Speaking, Product Launch, Strategy, Cross-functional Team..., Selling, Market Development, Market Planning, Vascular, Pharmaceutical Sales, Hospital Sales, ENT, Clinical Research, ISO 13485, Biotechnology, Managed Care, Lifesciences, Marketing Research, Interventional Radiology, Connecting People, Marketing Communications, Neurology, Pharmaceutical Industry, Management, Networking, P&L Management, International Marketing, Pricing, Professional Mentoring, Key Account Management, Competitive Intelligence, R&D, Oncology, Email Marketing, Capital Equipment, Sales, Sales Operations, Surgeons
Education
University of Denver - Daniels College of Business 1983 — 1985
BSBA, Marketing
Augsburg College 1979 — 1982
Psychology
Bob Lash, MD, BSEE/CS's Medical Device Consulting Experience 2010 - 2011
Job Senior Vice President and Chief R&D Officer at CardiOx Corporation
Industry Medical Devices
Experience
Cardiox Corporation 2011 - Present
InnovaMedix, Inc. 2011 - 2015
SurgOptix, Inc. 2011 - 2013
Medical Device Consulting 2010 - 2011
ViOptix, Inc. 2008 - 2010
ViOptix, Inc. 2002 - 2008
Driving Media, Inc. 2000 - 2001
Zorch, Inc. 1998 - 2000
Walt Disney Internet Group 1998 - 1998
WebChat Communications, Inc. 1993 - 1998
Skills
Medical Device R&D, Engineering Management, Product Development, Transducers and Data..., Signal Processing, Analog and Digital..., Fiberoptic and..., Electrical Safety..., FDA Compliance, Software Engineering, Embedded Control System..., Mechanical and..., Data Acquisition, Embedded Systems, Control Systems Design, FDA, Medical Devices, Quality System, Product Management, Strategic Partnerships, Start-ups, Electronics, Strategy, Integration, R&D, Cross-functional Team..., Program Management, Manufacturing, Product Marketing, Product Launch, Commercialization, Design Control, Market Development, Biomedical Engineering, Entrepreneurship, ISO 13485, Technology Transfer, Mergers & Acquisitions, Lifesciences, Validation, Surgery, Biotechnology, CAPA, Hardware Diagnostics, Venture Capital, Regulatory Affairs, Patents, V&V, Executive Management, Process Simulation
Education
University of California, San Diego - School of Medicine 1979 — 1983
M.D.
University of California, Berkeley 1975 — 1979
BS, Electrical Engineering and Computer Science
Cardiox Corporation 2011 - Present
InnovaMedix, Inc. 2011 - 2015
SurgOptix, Inc. 2011 - 2013
Medical Device Consulting 2010 - 2011
ViOptix, Inc. 2008 - 2010
ViOptix, Inc. 2002 - 2008
Driving Media, Inc. 2000 - 2001
Zorch, Inc. 1998 - 2000
Walt Disney Internet Group 1998 - 1998
WebChat Communications, Inc. 1993 - 1998
Skills
Medical Device R&D, Engineering Management, Product Development, Transducers and Data..., Signal Processing, Analog and Digital..., Fiberoptic and..., Electrical Safety..., FDA Compliance, Software Engineering, Embedded Control System..., Mechanical and..., Data Acquisition, Embedded Systems, Control Systems Design, FDA, Medical Devices, Quality System, Product Management, Strategic Partnerships, Start-ups, Electronics, Strategy, Integration, R&D, Cross-functional Team..., Program Management, Manufacturing, Product Marketing, Product Launch, Commercialization, Design Control, Market Development, Biomedical Engineering, Entrepreneurship, ISO 13485, Technology Transfer, Mergers & Acquisitions, Lifesciences, Validation, Surgery, Biotechnology, CAPA, Hardware Diagnostics, Venture Capital, Regulatory Affairs, Patents, V&V, Executive Management, Process Simulation
Education
University of California, San Diego - School of Medicine 1979 — 1983
M.D.
University of California, Berkeley 1975 — 1979
BS, Electrical Engineering and Computer Science
Cindy Doss Lowder Cindy Doss Lowder's Medical Device Consulting Experience July 2009 - September 2010
Job Director of Sales & Payor RelationsEastern U.S. at VQ OrthoCare
Industry Medical Devices
Experience
VQ OrthoCare September 2010 - Present
Medical Device Consulting July 2009 - September 2010
CSA Medical Inc February 2008 - July 2009
BioniCare Medical Technologies, Inc. July 2003 - February 2008
Univ of Maryland School of Medicine February 2000 - July 2003
Chesapeake Clinical Research February 1994 - July 2000
Skills
Certified Clinical..., Certified Clinical..., Medical Devices, Clinical Trial..., Start-ups, Clinical, Sales Management, Nursing, New Business Development, Hospitals, Clinical Trials, Strategic Planning, Healthcare, Orthopedics, Clinical Research, Pharmaceuticals, Biotechnology, Regulatory Affairs, Surgery, Oncology, Urology, Rheumatology, FDA, Clinical Development, Business Planning, Compliance, Gastroenterology, Orthopedic, Pharmaceutical Industry, New Product Launch, Operating Room, Cross-functional Team..., Market Development, Commercialization, Lifesciences, Sales Operations, Managed Care, Capital Equipment, Product Development, Cardiology, Product Launch, Surgeons, Neurology, Infectious Diseases, Leadership, ISO 13485, CTMS, Team Building, Disposables, Sales Force Development
Education
University of Maryland Baltimore 1989 — 1993
MS, Informatics (Focus: Clinical POC, education, research & administration)
Towson University 1977 — 1981
BSN, Nursing
VQ OrthoCare September 2010 - Present
Medical Device Consulting July 2009 - September 2010
CSA Medical Inc February 2008 - July 2009
BioniCare Medical Technologies, Inc. July 2003 - February 2008
Univ of Maryland School of Medicine February 2000 - July 2003
Chesapeake Clinical Research February 1994 - July 2000
Skills
Certified Clinical..., Certified Clinical..., Medical Devices, Clinical Trial..., Start-ups, Clinical, Sales Management, Nursing, New Business Development, Hospitals, Clinical Trials, Strategic Planning, Healthcare, Orthopedics, Clinical Research, Pharmaceuticals, Biotechnology, Regulatory Affairs, Surgery, Oncology, Urology, Rheumatology, FDA, Clinical Development, Business Planning, Compliance, Gastroenterology, Orthopedic, Pharmaceutical Industry, New Product Launch, Operating Room, Cross-functional Team..., Market Development, Commercialization, Lifesciences, Sales Operations, Managed Care, Capital Equipment, Product Development, Cardiology, Product Launch, Surgeons, Neurology, Infectious Diseases, Leadership, ISO 13485, CTMS, Team Building, Disposables, Sales Force Development
Education
University of Maryland Baltimore 1989 — 1993
MS, Informatics (Focus: Clinical POC, education, research & administration)
Towson University 1977 — 1981
BSN, Nursing
Paul Fischer's Medical Device Consulting Experience September 2014 - December 2014
Job Director of Program Management at Boston Scientific
Industry Medical Devices
Experience
Boston Scientific December 2014 - Present
Medical Device Consulting September 2014 - December 2014
Vascular Solutions June 2013 - September 2014
Boston Scientific November 2006 - May 2013
Boston Scientific August 2003 - November 2006
Boston Scientific September 2002 - August 2003
Vascular Solutions November 2000 - September 2002
Vascular Solutions November 1997 - November 2000
Possis Medical April 1996 - November 1997
Possis Medical July 1994 - April 1996
Skills
Program Management, Cross-functional Team..., Medical Devices, Product Development, Product Launch, Design Control, FDA, CAPA, V&V, Quality System, Validation, R&D, Process Improvement, FMEA, Biomedical Engineering, Clinical Research
Education
University of Minnesota-Twin Cities 1986 — 1991
Bachelor of Science (BS), Mechanical Engineering
Boston Scientific December 2014 - Present
Medical Device Consulting September 2014 - December 2014
Vascular Solutions June 2013 - September 2014
Boston Scientific November 2006 - May 2013
Boston Scientific August 2003 - November 2006
Boston Scientific September 2002 - August 2003
Vascular Solutions November 2000 - September 2002
Vascular Solutions November 1997 - November 2000
Possis Medical April 1996 - November 1997
Possis Medical July 1994 - April 1996
Skills
Program Management, Cross-functional Team..., Medical Devices, Product Development, Product Launch, Design Control, FDA, CAPA, V&V, Quality System, Validation, R&D, Process Improvement, FMEA, Biomedical Engineering, Clinical Research
Education
University of Minnesota-Twin Cities 1986 — 1991
Bachelor of Science (BS), Mechanical Engineering
Don Kolehmainen's Medical Device Consulting Experience October 2012 - Present
Job Owner at Medical Device Consulting
Industry Medical Devices
Experience
Medical Device Consulting October 2012 - Present
Visiogen Inc. August 2008 - December 2012
GluMetrics Inc. December 2005 - July 2008
MicroVention Inc. January 2004 - January 2006
Medical Device Consulting July 2002 - February 2004
TheraCardia, Inc. 1998 - 2002
MicroTherapeutics, Inc. 1995 - 1998
Imagyn Medical 1991 - 1995
Skills
Lean Manufacturing, Kaizen, Manufacturing..., Manufacturing, R&D, Engineering, Continuous Improvement, Process Improvement, ISO 13485, FDA, GMP, CAPA, Product Development, Design Control, Quality System, SPC, Entrepreneurship, Poka Yoke, Start-ups, Injection Molding, Commercialization, Operational Excellence, Product Launch, Root Cause Analysis, Process Engineering, V&V, Validation, ISO, Process Simulation, Engineering Management, Quality Assurance, Clinical Trials, DMAIC, Design for Manufacturing, 5S, Biomedical Engineering, Quality Control, Design of Experiments, Biotechnology, ISO 14971, Quality Auditing, Cross-functional Team..., Quality Management, FMEA, Minitab, Manufacturing Operations, Solidworks
Education
California Lutheran University
MBA, Business
Michigan Technological University
BSME, Mechanical Engineering
Medical Device Consulting October 2012 - Present
Visiogen Inc. August 2008 - December 2012
GluMetrics Inc. December 2005 - July 2008
MicroVention Inc. January 2004 - January 2006
Medical Device Consulting July 2002 - February 2004
TheraCardia, Inc. 1998 - 2002
MicroTherapeutics, Inc. 1995 - 1998
Imagyn Medical 1991 - 1995
Skills
Lean Manufacturing, Kaizen, Manufacturing..., Manufacturing, R&D, Engineering, Continuous Improvement, Process Improvement, ISO 13485, FDA, GMP, CAPA, Product Development, Design Control, Quality System, SPC, Entrepreneurship, Poka Yoke, Start-ups, Injection Molding, Commercialization, Operational Excellence, Product Launch, Root Cause Analysis, Process Engineering, V&V, Validation, ISO, Process Simulation, Engineering Management, Quality Assurance, Clinical Trials, DMAIC, Design for Manufacturing, 5S, Biomedical Engineering, Quality Control, Design of Experiments, Biotechnology, ISO 14971, Quality Auditing, Cross-functional Team..., Quality Management, FMEA, Minitab, Manufacturing Operations, Solidworks
Education
California Lutheran University
MBA, Business
Michigan Technological University
BSME, Mechanical Engineering
Joseph Tai's Medical Device Consulting Experience June 2013 - Present
Job Medical Device Professional | Project Management | Patents & Publications | Business Development |
Industry Medical Devices
Experience
Medical Device Consulting June 2013 - Present
AT Still University Arizona School of Health Sciences March 2011 - Present
LISI Medical January 2010 - June 2013
StratoFix Group January 2009 - January 2010
Alphatec Spine August 2006 - December 2008
Cytori Therapeutics (formerly MacroPore Biosurgery) March 2001 - August 2006
Medtronic Sofamor Danek 1993 - 2001
Skills
Medical Devices, Design Control, Lean Manufacturing, Six Sigma, Product Development, Manufacturing, Management, Leadership, Process Improvement, Business Development, ISO 13485, Orthopedic, Engineering, FDA, Spine, Training, Orthopedics
Education
A.T. Still University of Health Sciences
D.H.Sc., Health Sciences
Brigham Young University
BS, Design Engineering Technology
The University of Memphis
MBA
University of Utah
Master Eng, Bioengineering
Medical Device Consulting June 2013 - Present
AT Still University Arizona School of Health Sciences March 2011 - Present
LISI Medical January 2010 - June 2013
StratoFix Group January 2009 - January 2010
Alphatec Spine August 2006 - December 2008
Cytori Therapeutics (formerly MacroPore Biosurgery) March 2001 - August 2006
Medtronic Sofamor Danek 1993 - 2001
Skills
Medical Devices, Design Control, Lean Manufacturing, Six Sigma, Product Development, Manufacturing, Management, Leadership, Process Improvement, Business Development, ISO 13485, Orthopedic, Engineering, FDA, Spine, Training, Orthopedics
Education
A.T. Still University of Health Sciences
D.H.Sc., Health Sciences
Brigham Young University
BS, Design Engineering Technology
The University of Memphis
MBA
University of Utah
Master Eng, Bioengineering
Stephen Ryu's Medical Device Consulting Experience 2005 - Present
Job Neurosurgeon
Industry Medical Devices
Experience
Palo Alto Medical Foundation 2009 - Present
Stanford University 2009 - Present
Stanford Hospital & Clinics May 2013 - Present
Medical Device Consulting 2005 - Present
Stanford University 2006 - 2009
Skills
Surgery, Medical Devices, Clinical Research, Hospitals, Medicine, Neuroscience, Healthcare, Neurosurgery, Spine, Cognitive Neuroscience, Medical Education, Spinal Cord Injury, Radiology, Biomedical Engineering
Education
Stanford University School of Medicine 2006 — 2006
Fellowship, Spine Surgery
Stanford University 2002 — 2006
Post Doc, Neurosciences/Electrical Engineering
Stanford University School of Medicine 1999 — 2006
Neurosurgery
University of California, San Diego - School of Medicine 1995 — 1999
MD
Stanford University 1994 — 1995
MS, Electrical Engineering
Stanford University 1990 — 1994
BS, Electrical Engineering
Palo Alto Medical Foundation 2009 - Present
Stanford University 2009 - Present
Stanford Hospital & Clinics May 2013 - Present
Medical Device Consulting 2005 - Present
Stanford University 2006 - 2009
Skills
Surgery, Medical Devices, Clinical Research, Hospitals, Medicine, Neuroscience, Healthcare, Neurosurgery, Spine, Cognitive Neuroscience, Medical Education, Spinal Cord Injury, Radiology, Biomedical Engineering
Education
Stanford University School of Medicine 2006 — 2006
Fellowship, Spine Surgery
Stanford University 2002 — 2006
Post Doc, Neurosciences/Electrical Engineering
Stanford University School of Medicine 1999 — 2006
Neurosurgery
University of California, San Diego - School of Medicine 1995 — 1999
MD
Stanford University 1994 — 1995
MS, Electrical Engineering
Stanford University 1990 — 1994
BS, Electrical Engineering