Heartport Company
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Heartport Employees
Employee
Years
Job
Industry
Michi Garrison Michi Garrison's Heartport Experience 1993 - 1999
Job R&D Executive, Medical Device Industry
Industry Medical Devices
Experience
Intervene, Inc. September 2015 - Present
Silk Road Medical, Inc. August 2007 - September 2015
The Vertical Group September 2005 - August 2007
various 2003 - 2004
Cardiovasc, Inc. January 2000 - August 2003
Heartport 1993 - 1999
CVIS 1988 - 1993
Advanced Cardiovascular Systems 1988 - 1992
MiniMed Technologies 1984 - 1988
Skills
Biomedical Engineering, Start-ups, FDA, Commercialization, Medical Devices, R&D, Biotechnology, Product Launch, Market Development, CAPA, Validation, Regulatory Affairs, Patents, ISO 13485, V&V, Design of Experiments, Product Development, Design Control, Venture Capital, Entrepreneurship, Manufacturing, Strategy, Cross-functional Team..., Quality System, Catheters, Biomaterials, ISO 14971, Design for Manufacturing
Education
University of California, San Diego 1983 — 1984
M.S., Bioengineering
Harvard University 1979 — 1983
A.B., Engineering
Intervene, Inc. September 2015 - Present
Silk Road Medical, Inc. August 2007 - September 2015
The Vertical Group September 2005 - August 2007
various 2003 - 2004
Cardiovasc, Inc. January 2000 - August 2003
Heartport 1993 - 1999
CVIS 1988 - 1993
Advanced Cardiovascular Systems 1988 - 1992
MiniMed Technologies 1984 - 1988
Skills
Biomedical Engineering, Start-ups, FDA, Commercialization, Medical Devices, R&D, Biotechnology, Product Launch, Market Development, CAPA, Validation, Regulatory Affairs, Patents, ISO 13485, V&V, Design of Experiments, Product Development, Design Control, Venture Capital, Entrepreneurship, Manufacturing, Strategy, Cross-functional Team..., Quality System, Catheters, Biomaterials, ISO 14971, Design for Manufacturing
Education
University of California, San Diego 1983 — 1984
M.S., Bioengineering
Harvard University 1979 — 1983
A.B., Engineering
Hannah Cha Hannah Cha's Heartport Experience June 1994 - October 1997
Job Executive Assistant, People Operations at Google
Industry Internet
Experience
Google August 2005 - Present
Tele Atlas January 2003 - August 2005
Kana February 2000 - June 2001
Heartport June 1994 - October 1997
Skills
Business Development, Event Planning, Recruiting, Project Management, Social Media, System Administration, Social Networking, Human Resources
Education
University of California, Berkeley 1990 — 1993
Bachelor of Arts (BA), Art
Google August 2005 - Present
Tele Atlas January 2003 - August 2005
Kana February 2000 - June 2001
Heartport June 1994 - October 1997
Skills
Business Development, Event Planning, Recruiting, Project Management, Social Media, System Administration, Social Networking, Human Resources
Education
University of California, Berkeley 1990 — 1993
Bachelor of Arts (BA), Art
Becky Montgomery, CEBS, SPHR, MBA Becky Montgomery, CEBS, SPHR, MBA's Heartport Experience 1997 - 1999
Job Chief Human Resources Officer at Lewis Roca Rothgerber LLP
Industry Human Resources
Experience
Lewis Roca Rothgerber LLP June 2015 - Present
Independent Consulting October 2014 - June 2015
SWCA Environmental Consultants July 2001 - September 2014
Catholic Education Arizona 2010 - 2013
Leapsource January 2000 - April 2001
Alliant Food Service November 1999 - December 2000
The Phoenix Zoo 1998 - 1999
Heartport 1997 - 1999
Wilson Sonsini Goodrich and Rosati 1994 - 1996
Willis 1992 - 1994
Skills
360 Feedback Coaching..., SPHR, Affirmative Action..., Employee Stock..., Workplace safety, Employee Relations, Coaching, Workplace Safety, Applicant Tracking..., Mergers & Acquisitions, Business Planning, HRIS, Recruiting, Employee Benefits, Personnel Management, Organizational..., Performance Management, Human Resources, Training, Leadership, Management, Strategic Planning, Strategy, New Hire Orientations, Change Management
Education
Arizona State University 1997 — 2000
MBA, Human Resources Management and Services
University of the Pacific 1986 — 1990
BS, Business / Organizational Behavior
Lewis Roca Rothgerber LLP June 2015 - Present
Independent Consulting October 2014 - June 2015
SWCA Environmental Consultants July 2001 - September 2014
Catholic Education Arizona 2010 - 2013
Leapsource January 2000 - April 2001
Alliant Food Service November 1999 - December 2000
The Phoenix Zoo 1998 - 1999
Heartport 1997 - 1999
Wilson Sonsini Goodrich and Rosati 1994 - 1996
Willis 1992 - 1994
Skills
360 Feedback Coaching..., SPHR, Affirmative Action..., Employee Stock..., Workplace safety, Employee Relations, Coaching, Workplace Safety, Applicant Tracking..., Mergers & Acquisitions, Business Planning, HRIS, Recruiting, Employee Benefits, Personnel Management, Organizational..., Performance Management, Human Resources, Training, Leadership, Management, Strategic Planning, Strategy, New Hire Orientations, Change Management
Education
Arizona State University 1997 — 2000
MBA, Human Resources Management and Services
University of the Pacific 1986 — 1990
BS, Business / Organizational Behavior
Maureen Lopez Maureen Lopez's Heartport Experience 1996 - 1999
Job Executive Assistant to CEO and CFO at Confidential
Industry Biotechnology
Experience
Confidential June 2013 - Present
Coherus Biosciences, Inc. April 2012 - June 2013
W2O Group February 2011 - April 2012
Versant Ventures June 2008 - February 2011
Scios Inc. November 1998 - June 2008
Heartport 1996 - 1999
The Learning Company January 1988 - December 1995
Skills
Leadership, Management, Negotiation, Coaching, Public Speaking, Project Planning, Travel Arrangements, Outlook, Marketing, Team Building, Lotus Notes, PowerPoint, Biotechnology, Strategic Planning, Microsoft Excel, Microsoft Word, Research, Administrative..., Project Management, Microsoft Office
Education
University of Phoenix 2004 — 2006
MBA
University of Phoenix 1996 — 1998
BSBA
San Francisco State University 1974 — 1977
Undergraduate Coursework
Mills High School
Confidential June 2013 - Present
Coherus Biosciences, Inc. April 2012 - June 2013
W2O Group February 2011 - April 2012
Versant Ventures June 2008 - February 2011
Scios Inc. November 1998 - June 2008
Heartport 1996 - 1999
The Learning Company January 1988 - December 1995
Skills
Leadership, Management, Negotiation, Coaching, Public Speaking, Project Planning, Travel Arrangements, Outlook, Marketing, Team Building, Lotus Notes, PowerPoint, Biotechnology, Strategic Planning, Microsoft Excel, Microsoft Word, Research, Administrative..., Project Management, Microsoft Office
Education
University of Phoenix 2004 — 2006
MBA
University of Phoenix 1996 — 1998
BSBA
San Francisco State University 1974 — 1977
Undergraduate Coursework
Mills High School
Adam Sharkawy Adam Sharkawy's Heartport Experience 1996 - 1998
Job Managing Director at Consortium LLC
Industry Pharmaceuticals
Experience
Consortium Consulting LLC 2015 - Present
Soft Robotics Inc 2013 - Present
The Medicines Company 2013 - 2015
Smith & Nephew 2012 - 2013
Smith & Nephew 2010 - 2013
Abbott, Guidant Vascular 2004 - 2009
Ventrica Inc. (Acquired by Medtronic in 2004) 1998 - 2004
Heartport 1996 - 1998
Eli Lilly 1988 - 1993
Skills
Executive Management, Commercialization, Business Strategy, Leadership Development, Medical Devices, Start-ups, R&D, Biotechnology, Product Development, FDA, Business Development, Cross-functional Team..., Quality System, Leadership, Design Control, ISO 13485, Drug Delivery, V&V, Biomedical Engineering, Product Management, Validation, Venture Capital, Biomaterials, Patents, Technology Transfer, Engineering, Product Launch
Education
Duke University 1993 — 1996
Doctorate, Biomedical Engineering, Cell and Tissue Engineering
Texas A&M University 1989 — 1990
Masters of Science, Mechanical Engineering, Chaos Theory
The American University in Cairo 1984 — 1987
Bachelor of Science, Mechanical Engineering
University of Delaware 1981 — 1983
Two years towards Pre-medicine
Stanford University
Consortium Consulting LLC 2015 - Present
Soft Robotics Inc 2013 - Present
The Medicines Company 2013 - 2015
Smith & Nephew 2012 - 2013
Smith & Nephew 2010 - 2013
Abbott, Guidant Vascular 2004 - 2009
Ventrica Inc. (Acquired by Medtronic in 2004) 1998 - 2004
Heartport 1996 - 1998
Eli Lilly 1988 - 1993
Skills
Executive Management, Commercialization, Business Strategy, Leadership Development, Medical Devices, Start-ups, R&D, Biotechnology, Product Development, FDA, Business Development, Cross-functional Team..., Quality System, Leadership, Design Control, ISO 13485, Drug Delivery, V&V, Biomedical Engineering, Product Management, Validation, Venture Capital, Biomaterials, Patents, Technology Transfer, Engineering, Product Launch
Education
Duke University 1993 — 1996
Doctorate, Biomedical Engineering, Cell and Tissue Engineering
Texas A&M University 1989 — 1990
Masters of Science, Mechanical Engineering, Chaos Theory
The American University in Cairo 1984 — 1987
Bachelor of Science, Mechanical Engineering
University of Delaware 1981 — 1983
Two years towards Pre-medicine
Stanford University
Bob Nicholas's Heartport Experience August 1994 - August 2002
Job VP of Operations at Cardiokinetix
Industry Medical Devices
Experience
Cardiokinetix September 2012 - Present
Concentric Medical August 2002 - August 2012
Heartport August 1994 - August 2002
Falco Data Products July 1983 - August 1994
Skills
ASQ Certified Quality..., IPM CPM Certification, Certified GMP Auditor, JCIT International..., MedSource Lean..., Lean Manufacturing, Supply Chain, GMP, ISO 13485, Manufacturing, MRP, Commercialization, Design Control, Medical Devices, Purchasing, Product Development, R&D
Education
College of San Mateo 1981 — 1983
AS, Drafting and Design Technologies
College of San Mateo
Associate of Science (A.S.), Drafting and Design Technology/Technician, General
Cardiokinetix September 2012 - Present
Concentric Medical August 2002 - August 2012
Heartport August 1994 - August 2002
Falco Data Products July 1983 - August 1994
Skills
ASQ Certified Quality..., IPM CPM Certification, Certified GMP Auditor, JCIT International..., MedSource Lean..., Lean Manufacturing, Supply Chain, GMP, ISO 13485, Manufacturing, MRP, Commercialization, Design Control, Medical Devices, Purchasing, Product Development, R&D
Education
College of San Mateo 1981 — 1983
AS, Drafting and Design Technologies
College of San Mateo
Associate of Science (A.S.), Drafting and Design Technology/Technician, General
Robert Fishman Robert Fishman's Heartport Experience 1995 - 1997
Job Chief Medical Officer at Corcept Therapeutics
Industry Pharmaceuticals
Experience
Corcept Therapeutics 2015 - Present
InterMune 2012 - 2015
Alexza Pharmaceuticals 2008 - 2012
Anthera Pharmaceuticals 2005 - 2008
Aerogen 1997 - 2005
Heartport 1995 - 1997
Stanford University School of Medicine 1993 - 1995
Harvard University Health Services 1990 - 1993
Skills
Clinical Development, Clinical Trials, Drug Development, Medical Devices, FDA, Pulmonary Disease, Aerosol Science, Lifesciences, Pulmonology, Pharmaceutical Industry, Biotechnology, Internal Medicine, Asthma, Psychiatry, NDA, Hematology, Medicine, Clinical Research, Infectious Diseases, Biopharmaceuticals
Education
Massachusetts General Hospital 1989 — 1992
Fellowship in Pulmonary & Critical Care Medicine
BI / Deaconess Medical Center 1986 — 1989
Residency in Internal Medicine
Stanford University School of Medicine 1982 — 1986
MD, Medicine
Harvard University 1978 — 1982
AB, Biology
Corcept Therapeutics 2015 - Present
InterMune 2012 - 2015
Alexza Pharmaceuticals 2008 - 2012
Anthera Pharmaceuticals 2005 - 2008
Aerogen 1997 - 2005
Heartport 1995 - 1997
Stanford University School of Medicine 1993 - 1995
Harvard University Health Services 1990 - 1993
Skills
Clinical Development, Clinical Trials, Drug Development, Medical Devices, FDA, Pulmonary Disease, Aerosol Science, Lifesciences, Pulmonology, Pharmaceutical Industry, Biotechnology, Internal Medicine, Asthma, Psychiatry, NDA, Hematology, Medicine, Clinical Research, Infectious Diseases, Biopharmaceuticals
Education
Massachusetts General Hospital 1989 — 1992
Fellowship in Pulmonary & Critical Care Medicine
BI / Deaconess Medical Center 1986 — 1989
Residency in Internal Medicine
Stanford University School of Medicine 1982 — 1986
MD, Medicine
Harvard University 1978 — 1982
AB, Biology
Jim Weiss Jim Weiss's Heartport Experience 1996 - 1999
Job Owner, W2O Group
Industry Marketing and Advertising
Experience
W2O Group June 2001 - Present
Heartport 1996 - 1999
Rhone-Poulenc Rorer July 1995 - August 1996
Genentech 1992 - 1995
GTFH Public Relations July 1989 - February 1992
Hill & Knowlton 1987 - 1990
LobsenzStevens PR 1986 - 1986
Skills
Public Relations, Strategic Thinking, Media Relations, Digital Strategy, Integrated Marketing, Corporate Communications, Biotechnology, Social Media, Digital Marketing, Pharmaceutical Industry, Digital Media, Crisis Communications, Investor Relations
Education
Syracuse University 1983 — 1987
BS, Communications
W2O Group June 2001 - Present
Heartport 1996 - 1999
Rhone-Poulenc Rorer July 1995 - August 1996
Genentech 1992 - 1995
GTFH Public Relations July 1989 - February 1992
Hill & Knowlton 1987 - 1990
LobsenzStevens PR 1986 - 1986
Skills
Public Relations, Strategic Thinking, Media Relations, Digital Strategy, Integrated Marketing, Corporate Communications, Biotechnology, Social Media, Digital Marketing, Pharmaceutical Industry, Digital Media, Crisis Communications, Investor Relations
Education
Syracuse University 1983 — 1987
BS, Communications
Linda Indreboe's Heartport Experience 1996 - 1999
Job NPI Manufacturing Engineer
Industry Electrical/Electronic Manufacturing
Experience
KLA-Tencor 2005 - Present
Bay Area Snow Sports Council (BAC)/Far West Ski Association (FWSA) March 2006 - June 2007
Asyst Technologies 1999 - 2003
Heartport 1996 - 1999
Applied Biosystems 1989 - 1993
Skills
Lean Manufacturing, Product Launch, Cost Reduction, Program Management, Cross-functional Team..., Manufacturing, Team Building, Continuous Improvement, Process Improvement, Process Engineering, Project Planning, Design for Manufacturing, Process Development, Budgeting, Problem Solving, SAP, AutoCAD, Pro/Engineer, Excel, MS Project
Education
San Jose State University
MS, Industrial & Systems Engineering
California State University-Chico
BA, Mathematics
KLA-Tencor 2005 - Present
Bay Area Snow Sports Council (BAC)/Far West Ski Association (FWSA) March 2006 - June 2007
Asyst Technologies 1999 - 2003
Heartport 1996 - 1999
Applied Biosystems 1989 - 1993
Skills
Lean Manufacturing, Product Launch, Cost Reduction, Program Management, Cross-functional Team..., Manufacturing, Team Building, Continuous Improvement, Process Improvement, Process Engineering, Project Planning, Design for Manufacturing, Process Development, Budgeting, Problem Solving, SAP, AutoCAD, Pro/Engineer, Excel, MS Project
Education
San Jose State University
MS, Industrial & Systems Engineering
California State University-Chico
BA, Mathematics
Liz Hammack's Heartport Experience 1996 - 2000
Job VP Manufacturing and Operations, AF Solutions at Medtronic
Industry Medical Devices
Experience
Medtronic January 2009 - Present
Medtronic September 2004 - January 2009
Medtronic Vascular September 2002 - September 2004
Medtronic Cardiac Rhythm Disease Management July 2000 - August 2002
AVE / Medtronic Vascular 2000 - 2001
Heartport 1996 - 2000
Conceptus 1993 - 1996
Guidant 1986 - 1993
Raychem Corp. November 1982 - March 1984
Skills
Medical Devices, Lean Manufacturing, Product Development, Manufacturing Management, Supply Chain, Manufacturing..., Manufacturing, ISO 13485, Strategy, FDA, Continuous Improvement, Cross-functional Team..., Six Sigma, Leadership, Management, Process Improvement, DMAIC, Product Launch, P&L Management, Quality System, Commercialization, Design Control, Design of Experiments, CAPA, V&V, Manufacturing Operations, Manufacturing..., SPC, FMEA, Validation, ISO, Value Stream Mapping, Minitab, Kaizen, Root Cause Analysis, Operational Excellence, Supplier Quality, R&D, Process Simulation, Design for Manufacturing, GMP, Quality Management, Process Engineering, 5S, Industrial Engineering, Injection Molding, Capital Equipment, MRP, Black Belt, Contract Manufacturing
Education
Stanford GSB Executive Education 2002 — 2002
Supply Chain
Oregon State University 1978 — 1981
BS, Industrial Engineering
Medtronic January 2009 - Present
Medtronic September 2004 - January 2009
Medtronic Vascular September 2002 - September 2004
Medtronic Cardiac Rhythm Disease Management July 2000 - August 2002
AVE / Medtronic Vascular 2000 - 2001
Heartport 1996 - 2000
Conceptus 1993 - 1996
Guidant 1986 - 1993
Raychem Corp. November 1982 - March 1984
Skills
Medical Devices, Lean Manufacturing, Product Development, Manufacturing Management, Supply Chain, Manufacturing..., Manufacturing, ISO 13485, Strategy, FDA, Continuous Improvement, Cross-functional Team..., Six Sigma, Leadership, Management, Process Improvement, DMAIC, Product Launch, P&L Management, Quality System, Commercialization, Design Control, Design of Experiments, CAPA, V&V, Manufacturing Operations, Manufacturing..., SPC, FMEA, Validation, ISO, Value Stream Mapping, Minitab, Kaizen, Root Cause Analysis, Operational Excellence, Supplier Quality, R&D, Process Simulation, Design for Manufacturing, GMP, Quality Management, Process Engineering, 5S, Industrial Engineering, Injection Molding, Capital Equipment, MRP, Black Belt, Contract Manufacturing
Education
Stanford GSB Executive Education 2002 — 2002
Supply Chain
Oregon State University 1978 — 1981
BS, Industrial Engineering
Kate (Whitin) Lee's Heartport Experience March 1996 - May 1998
Job Senior Director Regulatory Affairs at Bigfoot Biomedical, Inc.
Industry Medical Devices
Experience
Bigfoot Biomedical, Inc. August 2015 - Present
Whitin Lee Consulting February 2015 - August 2015
Hansen Medical June 2008 - February 2015
Hansen Medical November 2005 - June 2008
NeoGuide Systems June 2002 - October 2005
Perclose May 1998 - August 2000
Heartport March 1996 - May 1998
Education
Stanford University 2000 — 2002
MS, Mechanical Engineering
Harvard University 1989 — 1993
BS, Mechanical Engineering
Bigfoot Biomedical, Inc. August 2015 - Present
Whitin Lee Consulting February 2015 - August 2015
Hansen Medical June 2008 - February 2015
Hansen Medical November 2005 - June 2008
NeoGuide Systems June 2002 - October 2005
Perclose May 1998 - August 2000
Heartport March 1996 - May 1998
Education
Stanford University 2000 — 2002
MS, Mechanical Engineering
Harvard University 1989 — 1993
BS, Mechanical Engineering
Russell Seiber's Heartport Experience 1997 - 2001
Job President, CEO and Founder at SentreHEART, Inc.
Industry Medical Devices
Experience
SentreHEART, Inc. October 2013 - Present
SentreHEART, Inc. April 2005 - Present
SentreHEART, Inc April 2005 - March 2012
Artemis Medical 2001 - 2004
Heartport 1997 - 2001
Boston Scientific 1989 - 1997
Procter & Gamble 1983 - 1988
Skills
Medical Devices, Commercialization, Product Development, Start-ups, Cross-functional Team..., Strategic Planning
Education
University of Florida 1979 — 1983
BS, Finance / Management
SentreHEART, Inc. October 2013 - Present
SentreHEART, Inc. April 2005 - Present
SentreHEART, Inc April 2005 - March 2012
Artemis Medical 2001 - 2004
Heartport 1997 - 2001
Boston Scientific 1989 - 1997
Procter & Gamble 1983 - 1988
Skills
Medical Devices, Commercialization, Product Development, Start-ups, Cross-functional Team..., Strategic Planning
Education
University of Florida 1979 — 1983
BS, Finance / Management
Kimberly Marquez's Heartport Experience 1996 - 2000
Job Vice President Quality Assurance at Alacrity Medical
Industry Medical Devices
Experience
Alacrity Medical, LLC October 2013 - Present
CIRTEC Medical Systems October 2009 - October 2013
Circle Medical Devices August 2008 - October 2009
Circle Medical Devices April 2008 - August 2008
M2 Medical July 2007 - April 2008
Boston Scientific October 2003 - July 2007
Guidant 2003 - 2007
ePeople 2000 - 2003
Heartport 1996 - 2000
Skills
V&V, ISO 13485, FDA, Medical Devices, Design Control, CAPA, Quality System, Quality Assurance, Biomedical Engineering, Validation, ISO 14971, R&D, GMP, FMEA, 21 CFR Part 11, Design of Experiments, ISO, Supplier Quality, CE marking, DMAIC, SPC, Quality Control, Regulatory Affairs, Minitab, Root Cause Analysis, Quality Management, 21 CFR, Catheters
Education
Michigan State University
Alacrity Medical, LLC October 2013 - Present
CIRTEC Medical Systems October 2009 - October 2013
Circle Medical Devices August 2008 - October 2009
Circle Medical Devices April 2008 - August 2008
M2 Medical July 2007 - April 2008
Boston Scientific October 2003 - July 2007
Guidant 2003 - 2007
ePeople 2000 - 2003
Heartport 1996 - 2000
Skills
V&V, ISO 13485, FDA, Medical Devices, Design Control, CAPA, Quality System, Quality Assurance, Biomedical Engineering, Validation, ISO 14971, R&D, GMP, FMEA, 21 CFR Part 11, Design of Experiments, ISO, Supplier Quality, CE marking, DMAIC, SPC, Quality Control, Regulatory Affairs, Minitab, Root Cause Analysis, Quality Management, 21 CFR, Catheters
Education
Michigan State University
Sandeep Saboo's Heartport Experience 1994 - 1998
Job Medical Device Quality Assurance, Regulatory Compliance & Regulatory Affairs consulting and training
Industry Medical Devices
Experience
Medical Device Quality/Regulatory Consulting April 2014 - Present
DFine, Inc. March 2006 - April 2014
Evalve, Inc. January 2002 - March 2006
Intella Interventional Systems, Inc. 2000 - 2002
Fox Hollow Technologies 1998 - 2000
Heartport 1994 - 1998
Medtronic Vascular February 1991 - December 1994
Skills
ISO 13485, Medical Devices, Design Control, FDA, Quality System, CAPA, R&D, Validation, GMP, Manufacturing, Root Cause Analysis, V&V, Design of Experiments, Product Development, Biomedical Engineering, Regulatory Affairs, Quality Assurance, Clinical Trials, Cross-functional Team..., SPC, Product Launch, FMEA, Market Development, Commercialization, ISO, Design for Manufacturing, ISO 14971, Six Sigma, Biotechnology, Injection Molding, Capital Equipment, Strategy, Change Control, Lean Manufacturing, DMAIC, Failure Analysis, Disposables, Solidworks, Quality Auditing, Orthopedic, Hardware Diagnostics, 21 CFR Part 11, Supplier Quality, Quality Control, Testing, CE marking, Start-ups, Medical Device Directive, Contract Manufacturing
Education
University of Massachusetts, Amherst 1987 — 1989
Master of Science (MS), Industrial Engineering & Operations Research
Birla Institute of Technology 1982 — 1986
B.S. (Engg), Mechanical Engineering
Scindia School 1975 — 1982
High School Graduate, School
Medical Device Quality/Regulatory Consulting April 2014 - Present
DFine, Inc. March 2006 - April 2014
Evalve, Inc. January 2002 - March 2006
Intella Interventional Systems, Inc. 2000 - 2002
Fox Hollow Technologies 1998 - 2000
Heartport 1994 - 1998
Medtronic Vascular February 1991 - December 1994
Skills
ISO 13485, Medical Devices, Design Control, FDA, Quality System, CAPA, R&D, Validation, GMP, Manufacturing, Root Cause Analysis, V&V, Design of Experiments, Product Development, Biomedical Engineering, Regulatory Affairs, Quality Assurance, Clinical Trials, Cross-functional Team..., SPC, Product Launch, FMEA, Market Development, Commercialization, ISO, Design for Manufacturing, ISO 14971, Six Sigma, Biotechnology, Injection Molding, Capital Equipment, Strategy, Change Control, Lean Manufacturing, DMAIC, Failure Analysis, Disposables, Solidworks, Quality Auditing, Orthopedic, Hardware Diagnostics, 21 CFR Part 11, Supplier Quality, Quality Control, Testing, CE marking, Start-ups, Medical Device Directive, Contract Manufacturing
Education
University of Massachusetts, Amherst 1987 — 1989
Master of Science (MS), Industrial Engineering & Operations Research
Birla Institute of Technology 1982 — 1986
B.S. (Engg), Mechanical Engineering
Scindia School 1975 — 1982
High School Graduate, School
Lorraine Martinez's Heartport Experience July 1995 - December 1997
Job Product Line Manager at IPG Photonics
Industry Medical Devices
Experience
IPG Photonics March 2013 - Present
Mobius Photonics (acquired by IPG Photonics) October 2010 - March 2013
Stay at Home Mom July 2006 - October 2010
Boston Scientific January 2003 - July 2006
Embol-X January 1998 - December 2002
Heartport July 1995 - December 1997
Skills
Medical Devices, Engineering Management, Engineering, Design for Manufacturing, Manufacturing, Product Development, Program Management, Start-ups, Solidworks, R&D, Cross-functional Team..., ISO 13485, Design Control, Management, Design of Experiments
Education
California Polytechnic State University-San Luis Obispo 1990 — 1995
BS, Mechanical Engineering
IPG Photonics March 2013 - Present
Mobius Photonics (acquired by IPG Photonics) October 2010 - March 2013
Stay at Home Mom July 2006 - October 2010
Boston Scientific January 2003 - July 2006
Embol-X January 1998 - December 2002
Heartport July 1995 - December 1997
Skills
Medical Devices, Engineering Management, Engineering, Design for Manufacturing, Manufacturing, Product Development, Program Management, Start-ups, Solidworks, R&D, Cross-functional Team..., ISO 13485, Design Control, Management, Design of Experiments
Education
California Polytechnic State University-San Luis Obispo 1990 — 1995
BS, Mechanical Engineering
Brian Walsh's Heartport Experience 1996 - 2001
Job President & CEO, Transcend Medical Inc.
Industry Medical Devices
Experience
Transcend Medical Inc August 2008 - Present
XTENT February 2004 - July 2008
Ventrica, Inc April 2002 - January 2004
Artemis Medical, Inc. June 2001 - April 2002
Heartport 1996 - 2001
Devices for Vascular Intervention, Guidant 1992 - 1996
Skills
Medical Devices, FDA, ISO 13485, Biotechnology, R&D, Clinical Trials, Product Development, Market Development, Surgery, Capital Equipment, Pharmaceutical Industry, Cardiology, Pricing Strategy, International Sales, Strategy, Business Acumen, Closing Deals, Lifesciences, International Marketing, Product Launch, Clinical Development, Biomedical Engineering, Global Marketing, Commercialization, Ophthalmology, Surgical Instruments, Life Sciences
Education
Saint Joseph's University
Transcend Medical Inc August 2008 - Present
XTENT February 2004 - July 2008
Ventrica, Inc April 2002 - January 2004
Artemis Medical, Inc. June 2001 - April 2002
Heartport 1996 - 2001
Devices for Vascular Intervention, Guidant 1992 - 1996
Skills
Medical Devices, FDA, ISO 13485, Biotechnology, R&D, Clinical Trials, Product Development, Market Development, Surgery, Capital Equipment, Pharmaceutical Industry, Cardiology, Pricing Strategy, International Sales, Strategy, Business Acumen, Closing Deals, Lifesciences, International Marketing, Product Launch, Clinical Development, Biomedical Engineering, Global Marketing, Commercialization, Ophthalmology, Surgical Instruments, Life Sciences
Education
Saint Joseph's University
Bob Casar's Heartport Experience 1999 - 2000
Job Medical Device and Pharmaceutical industry professional; broad range of QA, project, program, management expertise
Industry Medical Devices
Experience
Vascular Therapies 2011 - Present
Sorin Group January 2009 - August 2009
Datascope 2006 - 2009
Ethicon, a J&J Company 1995 - 2004
Heartport 1999 - 2000
NYU Hospital for Joint Diseases 1987 - 1994
Columbia University 1983 - 1986
Skills
Medical Devices, FDA, Cross-functional Team..., ISO 13485, R&D, Strategy, Product Development, Design Control, Quality Assurance, Product Launch, Project Management, CAPA, Manufacturing, Quality System, Design of Experiments, V&V, Regulatory Affairs, Biomedical Engineering, Clinical Research, GMP, Six Sigma, Commercialization, Class III Medical..., Validation, Change Control, Quality System..., Start-ups, Combination Products, Technology Transfer, DMAIC, ISO 14971
Education
Columbia University in the City of New York 1983 — 1986
MS, Engineering Mechanics
Stony Brook University 1978 — 1982
BE, Mechanical Engineering
Vascular Therapies 2011 - Present
Sorin Group January 2009 - August 2009
Datascope 2006 - 2009
Ethicon, a J&J Company 1995 - 2004
Heartport 1999 - 2000
NYU Hospital for Joint Diseases 1987 - 1994
Columbia University 1983 - 1986
Skills
Medical Devices, FDA, Cross-functional Team..., ISO 13485, R&D, Strategy, Product Development, Design Control, Quality Assurance, Product Launch, Project Management, CAPA, Manufacturing, Quality System, Design of Experiments, V&V, Regulatory Affairs, Biomedical Engineering, Clinical Research, GMP, Six Sigma, Commercialization, Class III Medical..., Validation, Change Control, Quality System..., Start-ups, Combination Products, Technology Transfer, DMAIC, ISO 14971
Education
Columbia University in the City of New York 1983 — 1986
MS, Engineering Mechanics
Stony Brook University 1978 — 1982
BE, Mechanical Engineering
Kirsten Valley's Heartport Experience 1993 - 1998
Job VP Regulatory, Clinical and Quality at Medina Medical
Industry Medical Devices
Experience
Medina Medical 2015 - Present
Twelve 2013 - 2015
Concentric Medical 2002 - 2012
RadioTherapeutics 1998 - 2002
Heartport 1993 - 1998
Guidant 1986 - 1993
Skills
Medical Devices, ISO 13485, R&D, FDA, Design Control, Pharmaceutical Industry, Clinical Trials, Clinical Research, CAPA, Commercialization, Regulatory Affairs, Quality Assurance, Biomedical Engineering, V&V, Quality System, Biotechnology, Market Development
Education
University of California, Davis
Bachelor's degree, Mechanical Engineering
Medina Medical 2015 - Present
Twelve 2013 - 2015
Concentric Medical 2002 - 2012
RadioTherapeutics 1998 - 2002
Heartport 1993 - 1998
Guidant 1986 - 1993
Skills
Medical Devices, ISO 13485, R&D, FDA, Design Control, Pharmaceutical Industry, Clinical Trials, Clinical Research, CAPA, Commercialization, Regulatory Affairs, Quality Assurance, Biomedical Engineering, V&V, Quality System, Biotechnology, Market Development
Education
University of California, Davis
Bachelor's degree, Mechanical Engineering
Star Westcott's Heartport Experience 1995 - 1998
Job Contracts Administrator at SF Based Pharma Company
Industry Biotechnology
Experience
Contractor July 2014 - September 2014
Jazz Pharmaceuticals August 2004 - August 2013
Mid Peninsula Boys & Girls Club 2003 - 2004
SUGEN / Pfizer 1998 - 2003
heartport 1995 - 1998
XXCAL, Inc. 1992 - 1995
Skills
Budgets, Program Management, Product Marketing, Human Resources, Advertising, Marketing, Fundraising, Photoshop, Graphic Design, Logo Design, InDesign, Cross-functional Team..., Flash, Graphics, Cardiology, Marketing Management, Publications, Illustrator, Adobe Acrobat, Pharmaceutical Sales, Marketing Strategy, Editing, Microsoft Word, Pharmaceutical Industry, Analysis, Time Management, Newsletters, Packaging, QuarkXPress, Illustration, Oncology, Clinical Trials, Product Development, Animation, Clinical Research, Posters, Lifesciences, PowerPoint, Sales, Microsoft Excel, Magazines, Document Management, Microsoft Office, Product Launch, Writing, Layout, Medical Devices, Image Manipulation, Strategic Planning, Art
Education
College of San Mateo 1980 — 1982
Graphics, Forestry
San Mateo High School 1976 — 1980
Contractor July 2014 - September 2014
Jazz Pharmaceuticals August 2004 - August 2013
Mid Peninsula Boys & Girls Club 2003 - 2004
SUGEN / Pfizer 1998 - 2003
heartport 1995 - 1998
XXCAL, Inc. 1992 - 1995
Skills
Budgets, Program Management, Product Marketing, Human Resources, Advertising, Marketing, Fundraising, Photoshop, Graphic Design, Logo Design, InDesign, Cross-functional Team..., Flash, Graphics, Cardiology, Marketing Management, Publications, Illustrator, Adobe Acrobat, Pharmaceutical Sales, Marketing Strategy, Editing, Microsoft Word, Pharmaceutical Industry, Analysis, Time Management, Newsletters, Packaging, QuarkXPress, Illustration, Oncology, Clinical Trials, Product Development, Animation, Clinical Research, Posters, Lifesciences, PowerPoint, Sales, Microsoft Excel, Magazines, Document Management, Microsoft Office, Product Launch, Writing, Layout, Medical Devices, Image Manipulation, Strategic Planning, Art
Education
College of San Mateo 1980 — 1982
Graphics, Forestry
San Mateo High School 1976 — 1980
Karen Pickthorn's Heartport Experience 1995 - 1999
Job Sr. Safety Scientist at Genentech
Industry Biotechnology
Experience
Genentech April 2013 - Present
KAI Pharmaceuticals August 2004 - December 2012
RITA Medical Systems 2000 - 2004
Boston Scientific, Target Therapeutics 1999 - 2000
Heartport 1995 - 1999
Intermedics 1994 - 1995
Education
The University of Texas Health Science Center at Houston 1991 — 1993
MS, Biometry
Iowa State University 1983 — 1987
DVM, Veterinary Medicine
Iowa State University 1980 — 1984
BS, Biology
Genentech April 2013 - Present
KAI Pharmaceuticals August 2004 - December 2012
RITA Medical Systems 2000 - 2004
Boston Scientific, Target Therapeutics 1999 - 2000
Heartport 1995 - 1999
Intermedics 1994 - 1995
Education
The University of Texas Health Science Center at Houston 1991 — 1993
MS, Biometry
Iowa State University 1983 — 1987
DVM, Veterinary Medicine
Iowa State University 1980 — 1984
BS, Biology
Tim Machold's Heartport Experience February 1992 - July 1994
Job Consultant at Niveus Medical
Industry Medical Devices
Experience
Niveus Medical November 2011 - Present
MVRx November 2009 - Present
PneumRx Incorporated 2009 - Present
Ample Medical September 2002 - June 2009
Radiant Medical 1997 - 2002
Transvascular January 1996 - August 1997
HeartPort February 1992 - July 1994
Advanced Cardiovascular Systems 1986 - 1992
Education
University of California, Berkeley 1974 — 1977
BS
Niveus Medical November 2011 - Present
MVRx November 2009 - Present
PneumRx Incorporated 2009 - Present
Ample Medical September 2002 - June 2009
Radiant Medical 1997 - 2002
Transvascular January 1996 - August 1997
HeartPort February 1992 - July 1994
Advanced Cardiovascular Systems 1986 - 1992
Education
University of California, Berkeley 1974 — 1977
BS
Minoo Mama's Heartport Experience 1996 - 1998
Job Managing Director, MSM Consulting
Industry Medical Devices
Experience
MSM Consulting April 2014 - Present
Thoratec December 2011 - March 2014
Medtronic Spine & Biologics May 2005 - December 2011
Kyphon May 2005 - November 2007
Beahm Designs, Inc October 2004 - January 2005
Advanced Stent Technologies (Aquired by Boston Scientific Corp.) October 2002 - September 2004
Vascular Architects 2000 - 2002
Keravision 1998 - 2000
Heartport 1996 - 1998
Guidant 1993 - 1996
Skills
Design for Manufacturing, Manufacturing..., ISO 13485, Biomedical Engineering, Six Sigma, Manufacturing, Medical Devices, Product Development, Design of Experiments, Catheters, Design Control, ISO 14971, FDA, Process Engineering, R&D, CAPA, Root Cause Analysis, Commercialization, Quality System, V&V, FMEA, Validation, SPC, Injection Molding, Minitab, ISO, GMP, Supplier Quality, Lean Manufacturing, Process Simulation, Testing
Education
Stanford University
MS, Mechanical Engineering
MSM Consulting April 2014 - Present
Thoratec December 2011 - March 2014
Medtronic Spine & Biologics May 2005 - December 2011
Kyphon May 2005 - November 2007
Beahm Designs, Inc October 2004 - January 2005
Advanced Stent Technologies (Aquired by Boston Scientific Corp.) October 2002 - September 2004
Vascular Architects 2000 - 2002
Keravision 1998 - 2000
Heartport 1996 - 1998
Guidant 1993 - 1996
Skills
Design for Manufacturing, Manufacturing..., ISO 13485, Biomedical Engineering, Six Sigma, Manufacturing, Medical Devices, Product Development, Design of Experiments, Catheters, Design Control, ISO 14971, FDA, Process Engineering, R&D, CAPA, Root Cause Analysis, Commercialization, Quality System, V&V, FMEA, Validation, SPC, Injection Molding, Minitab, ISO, GMP, Supplier Quality, Lean Manufacturing, Process Simulation, Testing
Education
Stanford University
MS, Mechanical Engineering
Gilbert Mata's Heartport Experience July 1998 - August 2000
Job Manufacturing Engineer at Invuity, Inc.
Industry Medical Devices
Experience
Invuity, Inc. September 2014 - Present
BioVentrix April 2012 - July 2014
BARRX Medical January 2011 - April 2012
Satiety Inc November 2001 - December 2010
Heartport Inc August 2000 - October 2001
Heartport July 1998 - August 2000
Heartport May 1997 - July 1998
Heartport October 1996 - May 1997
Trine Manufacturing, Turlock, Ca. June 1994 - October 1996
Trine Manufacturing, Turlock, Ca. June 1990 - June 1994
Skills
Machining, Tolerance Analysis, Product Development, R&D, V&V, ISO 13485, Catheters, Manufacturing, Medical Devices, Adhesives, Machine Tools, FMEA, CAPA, Solidworks, Design Control, Fixture Design, Quality System, FDA, Biomedical Engineering, Product Design
Education
San Jose State University
Evergreen Valley College
Degree- Associate of Arts
Invuity, Inc. September 2014 - Present
BioVentrix April 2012 - July 2014
BARRX Medical January 2011 - April 2012
Satiety Inc November 2001 - December 2010
Heartport Inc August 2000 - October 2001
Heartport July 1998 - August 2000
Heartport May 1997 - July 1998
Heartport October 1996 - May 1997
Trine Manufacturing, Turlock, Ca. June 1994 - October 1996
Trine Manufacturing, Turlock, Ca. June 1990 - June 1994
Skills
Machining, Tolerance Analysis, Product Development, R&D, V&V, ISO 13485, Catheters, Manufacturing, Medical Devices, Adhesives, Machine Tools, FMEA, CAPA, Solidworks, Design Control, Fixture Design, Quality System, FDA, Biomedical Engineering, Product Design
Education
San Jose State University
Evergreen Valley College
Degree- Associate of Arts
Chris Hubbard's Heartport Experience 1996 - 2001
Job at
Industry Medical Devices
Experience
St. Jude Medical October 2013 - Present
Nanostim, Inc. September 2009 - Present
Aptus Endosystems September 2008 - September 2009
Devax October 2007 - May 2008
St. Jude Medical 2002 - 2006
Heartport 1996 - 2001
Skills
Capital Equipment, Medical Devices, Surgeons, Market Development, ISO 13485, FDA, Interventional..., Cath Lab, Interventional Radiology, Disposables, Vascular, Cardiology, Surgery, Commercialization, Product Launch
Education
Benedictine University 2007 — 2009
Master of Business Administration (M.B.A.), Marketing-Entrepreneurship
University of Illinois at Urbana-Champaign 1976 — 1980
B.S., Marketing
St. Jude Medical October 2013 - Present
Nanostim, Inc. September 2009 - Present
Aptus Endosystems September 2008 - September 2009
Devax October 2007 - May 2008
St. Jude Medical 2002 - 2006
Heartport 1996 - 2001
Skills
Capital Equipment, Medical Devices, Surgeons, Market Development, ISO 13485, FDA, Interventional..., Cath Lab, Interventional Radiology, Disposables, Vascular, Cardiology, Surgery, Commercialization, Product Launch
Education
Benedictine University 2007 — 2009
Master of Business Administration (M.B.A.), Marketing-Entrepreneurship
University of Illinois at Urbana-Champaign 1976 — 1980
B.S., Marketing