Advanced Cardiovascular Systems
Industry: Company
DescriptionParent organization: Abbott Laboratories Subsidiary: Guidant GmbH & Co Medizintechnik KG
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Advanced Cardiovascular Systems Employees
Employee
Years
Job
Industry
Bruce Prothro Bruce Prothro's Advanced Cardiovascular Systems Experience January 1988 - October 1992
Job Vice President, Global Regulatory Affairs at Smith & Nephew
Industry Medical Devices
Experience
Smith & Nephew October 2014 - Present
Smith & Nephew August 2014 - October 2014
ArthroCare Corporation October 1998 - July 2014
KeraVision 1992 - 1998
Advanced Cardiovascular Systems January 1988 - October 1992
Diamon Images 1985 - 1988
Skills
Manufacturing, Quality Assurance, Medical Devices, ISO 13485, Design Control, FDA, CAPA, Quality System, ISO 14971, V&V, Validation, GMP, Regulatory Affairs, Design of Experiments, R&D, CE marking, Product Development, Quality Control, Supplier Quality, Catheters, SPC, 21 CFR Part 11, Quality Management, FMEA, Biotechnology, Change Control, Biomedical Engineering, Root Cause Analysis, Regulatory Submissions, Cross-functional Team..., Process Engineering, Clinical Trials, ISO, DMAIC, Commercialization, Sop, Quality Auditing, Technology Transfer, Process Simulation, GxP, Clinical Development, Minitab, Testing, Sterilization, Regulatory Requirements, PMA, Iso 9000, Injection Molding, 21 CFR, Manufacturing Operations
Education
University of California, Berkeley 1980 — 1984
BS, Chemistry
Del Mar High School 1976 — 1980
Smith & Nephew October 2014 - Present
Smith & Nephew August 2014 - October 2014
ArthroCare Corporation October 1998 - July 2014
KeraVision 1992 - 1998
Advanced Cardiovascular Systems January 1988 - October 1992
Diamon Images 1985 - 1988
Skills
Manufacturing, Quality Assurance, Medical Devices, ISO 13485, Design Control, FDA, CAPA, Quality System, ISO 14971, V&V, Validation, GMP, Regulatory Affairs, Design of Experiments, R&D, CE marking, Product Development, Quality Control, Supplier Quality, Catheters, SPC, 21 CFR Part 11, Quality Management, FMEA, Biotechnology, Change Control, Biomedical Engineering, Root Cause Analysis, Regulatory Submissions, Cross-functional Team..., Process Engineering, Clinical Trials, ISO, DMAIC, Commercialization, Sop, Quality Auditing, Technology Transfer, Process Simulation, GxP, Clinical Development, Minitab, Testing, Sterilization, Regulatory Requirements, PMA, Iso 9000, Injection Molding, 21 CFR, Manufacturing Operations
Education
University of California, Berkeley 1980 — 1984
BS, Chemistry
Del Mar High School 1976 — 1980
Michi Garrison Michi Garrison's Advanced Cardiovascular Systems Experience 1988 - 1992
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
Don Swanston's Advanced Cardiovascular Systems Experience January 1993 - November 1994
Job Medical Device Professional | Quality Assurance
Industry Medical Devices
Experience
- 2010 - Present
Abbott Vascular April 2008 - September 2011
Abbott Vascular April 2006 - January 2008
Guidant April 2005 - April 2006
Guidant January 2004 - April 2005
Guidant January 2000 - January 2003
Guidant January 1998 - January 2000
Guidant November 1994 - April 1998
Advanced Cardiovascular Systems January 1993 - November 1994
Advanced Cardiovascular Systems November 1989 - January 1993
Skills
Design Control, ISO 13485, CAPA, Quality System, ISO 14971, Quality System..., Part 820, FDA, Integration, Manufacturing, Manufacturing..., Medical Devices, Process Improvement, Product Development, Program Management, Quality Assurance, Quality Auditing, Root Cause Analysis, SPC, Six Sigma, Testing, V, Validation
Education
Skillsoft/American Society of Quality 2010 — 2010
Lean/Six Sigma Black Belt body of knowledge (BOK) courses
University of Southern California 1984 — 1986
MS, Systems Management
California State University, Fresno 1978 — 1980
BS, Industrial Technology, Manufacturing
Fullerton College 1976 — 1978
AA, University Transfer Studies
Regalutory Affairs Professional Society (RAPS)
RAPS Regulatory Affairs medical device certificate program
- 2010 - Present
Abbott Vascular April 2008 - September 2011
Abbott Vascular April 2006 - January 2008
Guidant April 2005 - April 2006
Guidant January 2004 - April 2005
Guidant January 2000 - January 2003
Guidant January 1998 - January 2000
Guidant November 1994 - April 1998
Advanced Cardiovascular Systems January 1993 - November 1994
Advanced Cardiovascular Systems November 1989 - January 1993
Skills
Design Control, ISO 13485, CAPA, Quality System, ISO 14971, Quality System..., Part 820, FDA, Integration, Manufacturing, Manufacturing..., Medical Devices, Process Improvement, Product Development, Program Management, Quality Assurance, Quality Auditing, Root Cause Analysis, SPC, Six Sigma, Testing, V, Validation
Education
Skillsoft/American Society of Quality 2010 — 2010
Lean/Six Sigma Black Belt body of knowledge (BOK) courses
University of Southern California 1984 — 1986
MS, Systems Management
California State University, Fresno 1978 — 1980
BS, Industrial Technology, Manufacturing
Fullerton College 1976 — 1978
AA, University Transfer Studies
Regalutory Affairs Professional Society (RAPS)
RAPS Regulatory Affairs medical device certificate program
Stacey Soboleski Stacey Soboleski's Advanced Cardiovascular Systems Experience 1995 - 1997
Job Holistic Health & Wellness Coach at Nourishing Compass
Industry Health, Wellness and Fitness
Experience
Nourishing Compass January 2013 - Present
Advanced Cardiovascular Systems 1995 - 1997
Schneider USA 1993 - 1995
Skills
Psychotherapy, Holistic Health, Medical Devices, Community Outreach, Wellness Coaching, Health Education, Workshop Facilitation, Treatment, Program Development, Leadership Development, Coaching, Wellness, Fitness, Lifestyle Coaching, Management, Nutrition, Stress Management
Education
Institute of Integrative Nutrition
University of Colorado at Boulder
Bachelor of Arts, Psychology
Nourishing Compass January 2013 - Present
Advanced Cardiovascular Systems 1995 - 1997
Schneider USA 1993 - 1995
Skills
Psychotherapy, Holistic Health, Medical Devices, Community Outreach, Wellness Coaching, Health Education, Workshop Facilitation, Treatment, Program Development, Leadership Development, Coaching, Wellness, Fitness, Lifestyle Coaching, Management, Nutrition, Stress Management
Education
Institute of Integrative Nutrition
University of Colorado at Boulder
Bachelor of Arts, Psychology
Anna Economy's Advanced Cardiovascular Systems Experience 1982 - 1989
Job OA at the California Health Benefit Exchange~Covered California
Industry Consumer Services
Experience
California Health Benefit Exchange ~ Covered California March 2014 - Present
Directly.COM April 2011 - Present
Service Response Partners LL March 2013 - November 2013
AT&T Mobility LLC September 2006 - September 2012
Wireless Asset Management June 2004 - March 2006
Westaff Personnel Services May 2003 - April 2004
Apple-One Employment Services January 2002 - October 2002
Prince Telecom March 1999 - May 2001
Advanced Cardiovascular Systems 1982 - 1989
Skills
Troubleshooting, Fax, Telecommunications, Data Entry, Computer Hardware, Problem Solving, Microsoft Office Suite, Wireless Access, Order Entry, Inventory Management, DSL, Outstanding Customer..., Software Installation, Windows Platforms, Wireless Networking, Typing, Account Management, Desktop Support, Billing Systems, Retail, Lotus Notes, Cabling, Documentation, Customer Service, Office Administration, Software Documentation, Project Management, Management, Sales, Budgets, Microsoft Office, Call Centers, Wireless, Project Planning, Customer Satisfaction, Networking, Training, Quality Assurance, Administration, Start-ups, Team Leadership, Process Improvement, Vendor Management
Education
California State University-Chico 1976 — 1982
Bachelor of Science Degree, Personnel and Industrial Relations, Business Administration
California Health Benefit Exchange ~ Covered California March 2014 - Present
Directly.COM April 2011 - Present
Service Response Partners LL March 2013 - November 2013
AT&T Mobility LLC September 2006 - September 2012
Wireless Asset Management June 2004 - March 2006
Westaff Personnel Services May 2003 - April 2004
Apple-One Employment Services January 2002 - October 2002
Prince Telecom March 1999 - May 2001
Advanced Cardiovascular Systems 1982 - 1989
Skills
Troubleshooting, Fax, Telecommunications, Data Entry, Computer Hardware, Problem Solving, Microsoft Office Suite, Wireless Access, Order Entry, Inventory Management, DSL, Outstanding Customer..., Software Installation, Windows Platforms, Wireless Networking, Typing, Account Management, Desktop Support, Billing Systems, Retail, Lotus Notes, Cabling, Documentation, Customer Service, Office Administration, Software Documentation, Project Management, Management, Sales, Budgets, Microsoft Office, Call Centers, Wireless, Project Planning, Customer Satisfaction, Networking, Training, Quality Assurance, Administration, Start-ups, Team Leadership, Process Improvement, Vendor Management
Education
California State University-Chico 1976 — 1982
Bachelor of Science Degree, Personnel and Industrial Relations, Business Administration
Maureen Ludwig Maureen Ludwig's Advanced Cardiovascular Systems Experience 1987 - 1990
Job Corporate Occupational Health and Wellness Executive
Industry Health, Wellness and Fitness
Experience
Business Health Affiliates, Inc. June 1995 - Present
California Pacific Medical Center 1991 - 1995
UCSF 1989 - 1994
The Stone Clinic January 1990 - October 1991
Advanced Cardiovascular Systems 1987 - 1990
Stanford University Medical Center July 1980 - July 1987
Skills
Occupational Health, Customer Service, Wellness, Program Development, Healthcare Management, Marketing Strategy, Employee Wellness..., Operations Management, Staff Management, Health Promotion, Social Media, Team Building, Hospitals, Business Decision Making, Contract Negotiation, Immunization, Employee Training, Staff Development, Healthcare, Sales, Policy Writing, Legal Nurse Consulting, Microsoft Word, Business Development, Management, Human Resources
Education
UCSF
Master's degree(s), Occupational Health/Legal Compliance and Adult Nurse Practitioner
UCSF
Bachelor of Applied Science (B.A.Sc.), Adult Health Nurse/Nursing
Business Health Affiliates, Inc. June 1995 - Present
California Pacific Medical Center 1991 - 1995
UCSF 1989 - 1994
The Stone Clinic January 1990 - October 1991
Advanced Cardiovascular Systems 1987 - 1990
Stanford University Medical Center July 1980 - July 1987
Skills
Occupational Health, Customer Service, Wellness, Program Development, Healthcare Management, Marketing Strategy, Employee Wellness..., Operations Management, Staff Management, Health Promotion, Social Media, Team Building, Hospitals, Business Decision Making, Contract Negotiation, Immunization, Employee Training, Staff Development, Healthcare, Sales, Policy Writing, Legal Nurse Consulting, Microsoft Word, Business Development, Management, Human Resources
Education
UCSF
Master's degree(s), Occupational Health/Legal Compliance and Adult Nurse Practitioner
UCSF
Bachelor of Applied Science (B.A.Sc.), Adult Health Nurse/Nursing
Ron Koronkowski Ron Koronkowski's Advanced Cardiovascular Systems Experience March 1989 - April 1990
Job Director, Quality & Regulatory at Vention Medical, Inc.
Industry Medical Devices
Experience
Vention Medical, Inc. January 2013 - Present
Guided Delivery Systems, Inc. August 2011 - January 2013
BioCardia September 2009 - August 2011
Aptus Endosystems, Inc. November 2003 - August 2009
Bacchus Vascular September 2001 - November 2003
Waterfall Co., Inc. October 2000 - September 2001
Salient Interventional Systems, Inc. August 1999 - October 2000
Medtronic Vascular (AneuRx) December 1998 - August 1999
St. Jude Medical (Ventritex) April 1990 - November 1998
Advanced Cardiovascular Systems March 1989 - April 1990
Skills
FDA, Design Control, Medical Devices, ISO 13485, ISO 14971, 21 CFR, 21 CFR Part 11, Biocompatibility, Biomedical Engineering, Biotechnology, CAPA, CE marking, CQA, Catheters, Change Control, Commercialization, Cross-functional Team..., Design for Manufacturing, Design of Experiments, FDA GMP, FMEA, GMP, ISO, Injection Molding, Leadership, Lean Manufacturing, Manufacturing, Manufacturing..., Medical Device Directive, Minitab, PMA, Product Development, Quality Assurance, Quality Auditing, Quality Control, Quality Management, Quality System, R, Regulatory Affairs, Regulatory Submissions, Root Cause Analysis, SPC, Start-ups, Sterilization, Supplier Quality, V, Validation
Education
Illinois Institute of Technology 1980 — 1984
BS, Mechanical Engineering
Vention Medical, Inc. January 2013 - Present
Guided Delivery Systems, Inc. August 2011 - January 2013
BioCardia September 2009 - August 2011
Aptus Endosystems, Inc. November 2003 - August 2009
Bacchus Vascular September 2001 - November 2003
Waterfall Co., Inc. October 2000 - September 2001
Salient Interventional Systems, Inc. August 1999 - October 2000
Medtronic Vascular (AneuRx) December 1998 - August 1999
St. Jude Medical (Ventritex) April 1990 - November 1998
Advanced Cardiovascular Systems March 1989 - April 1990
Skills
FDA, Design Control, Medical Devices, ISO 13485, ISO 14971, 21 CFR, 21 CFR Part 11, Biocompatibility, Biomedical Engineering, Biotechnology, CAPA, CE marking, CQA, Catheters, Change Control, Commercialization, Cross-functional Team..., Design for Manufacturing, Design of Experiments, FDA GMP, FMEA, GMP, ISO, Injection Molding, Leadership, Lean Manufacturing, Manufacturing, Manufacturing..., Medical Device Directive, Minitab, PMA, Product Development, Quality Assurance, Quality Auditing, Quality Control, Quality Management, Quality System, R, Regulatory Affairs, Regulatory Submissions, Root Cause Analysis, SPC, Start-ups, Sterilization, Supplier Quality, V, Validation
Education
Illinois Institute of Technology 1980 — 1984
BS, Mechanical Engineering
Rick Helkowski Rick Helkowski's Advanced Cardiovascular Systems Experience 1987 - 1988
Job Vice President, Research & Development at ZOLL Circulation
Industry Medical Devices
Experience
ZOLL Circulation May 2008 - Present
Biomerix Corporation 2006 - 2007
Corazon Technologies, Inc. 2001 - 2005
Concentric Medical 2000 - 2002
CardioThoracic Systems 1998 - 2000
St. Jude Medical 1993 - 1998
BOC/Ohmeda 1988 - 1993
Advanced Cardiovascular Systems 1987 - 1988
American Edwards Laboratories 1983 - 1987
Skills
Medical Devices, Research & Development, Product Development, Design Engineering, Mechanical Engineering, Managing Technical..., Engineering Management
Education
Georgia Institute of Technology 1974 — 1979
BME, Mechanical Engineering and Material Science
Loyola University Maryland 1980 — 1981
MBA, Marketing
ZOLL Circulation May 2008 - Present
Biomerix Corporation 2006 - 2007
Corazon Technologies, Inc. 2001 - 2005
Concentric Medical 2000 - 2002
CardioThoracic Systems 1998 - 2000
St. Jude Medical 1993 - 1998
BOC/Ohmeda 1988 - 1993
Advanced Cardiovascular Systems 1987 - 1988
American Edwards Laboratories 1983 - 1987
Skills
Medical Devices, Research & Development, Product Development, Design Engineering, Mechanical Engineering, Managing Technical..., Engineering Management
Education
Georgia Institute of Technology 1974 — 1979
BME, Mechanical Engineering and Material Science
Loyola University Maryland 1980 — 1981
MBA, Marketing
Larry Brennan Larry Brennan's Advanced Cardiovascular Systems Experience November 1992 - 1994
Job Quality Director at Abbott Vascular
Industry Medical Devices
Experience
Abbott Laboratories 2006 - Present
Guidant 1994 - 2006
Advanced Cardiovascular Systems November 1992 - 1994
Skills
Quality Systems, CAPA, Process Validation, Design Control, Quality Engineering, Quality System, Medical Devices, FDA, V&V, Cross-functional Team..., Validation, GMP, 21 CFR Part 11, ISO 14971, ISO 13485, Change Control, Quality Control, Design of Experiments, Quality Auditing, Computer System...
Education
Cal State Dominguez Hills
University of Phoenix
Abbott Laboratories 2006 - Present
Guidant 1994 - 2006
Advanced Cardiovascular Systems November 1992 - 1994
Skills
Quality Systems, CAPA, Process Validation, Design Control, Quality Engineering, Quality System, Medical Devices, FDA, V&V, Cross-functional Team..., Validation, GMP, 21 CFR Part 11, ISO 14971, ISO 13485, Change Control, Quality Control, Design of Experiments, Quality Auditing, Computer System...
Education
Cal State Dominguez Hills
University of Phoenix
Caren Carr Caren Carr's Advanced Cardiovascular Systems Experience 1993 - 1996
Job Western Area Vice President at Medtronic Interventional Lung Solutions
Industry Medical Devices
Experience
Covidien October 2014 - Present
Covidien February 2013 - October 2014
Vertos Medical Inc August 2012 - February 2013
Vertos Medical Inc September 2010 - August 2012
Medtronic Neuromodulation May 1997 - September 2010
Schneider/Namic 1996 - 1997
Advanced Cardiovascular Systems 1993 - 1996
US Surgical 1989 - 1993
Skills
Operating Room, Market Development, Vascular Surgery, Spine, Disposables, Surgery, Medical Devices, Neurology, Pain Management, Pharmaceutical Sales, Sales Operations, Medical Equipment, Neurosurgery, Sales Force Development, Operating Room Sales, ENT, Surgical Instruments, Interventional..., Cath Lab, Capital Equipment, Cardiology, Vascular, Surgeons, Interventional Radiology, Hospitals, Sales Effectiveness, General Surgery, Cross-functional Team..., OB/GYN, Capital Equipment Sales, Medical Sales, Cardiac Surgery, Medical Imaging, Healthcare, Orthopedic, Gastroenterology, Urology, Product Launch, Biologics, Hospital Sales, Surgical Device Sales, Endocrinology, Selling Skills, Global Marketing, Commercialization, KOL development, Endoscopy, Pulmonology, Rheumatology, Sales
Education
University of North Texas 1985 — 1987
BBA, Business/Marketing
Covidien October 2014 - Present
Covidien February 2013 - October 2014
Vertos Medical Inc August 2012 - February 2013
Vertos Medical Inc September 2010 - August 2012
Medtronic Neuromodulation May 1997 - September 2010
Schneider/Namic 1996 - 1997
Advanced Cardiovascular Systems 1993 - 1996
US Surgical 1989 - 1993
Skills
Operating Room, Market Development, Vascular Surgery, Spine, Disposables, Surgery, Medical Devices, Neurology, Pain Management, Pharmaceutical Sales, Sales Operations, Medical Equipment, Neurosurgery, Sales Force Development, Operating Room Sales, ENT, Surgical Instruments, Interventional..., Cath Lab, Capital Equipment, Cardiology, Vascular, Surgeons, Interventional Radiology, Hospitals, Sales Effectiveness, General Surgery, Cross-functional Team..., OB/GYN, Capital Equipment Sales, Medical Sales, Cardiac Surgery, Medical Imaging, Healthcare, Orthopedic, Gastroenterology, Urology, Product Launch, Biologics, Hospital Sales, Surgical Device Sales, Endocrinology, Selling Skills, Global Marketing, Commercialization, KOL development, Endoscopy, Pulmonology, Rheumatology, Sales
Education
University of North Texas 1985 — 1987
BBA, Business/Marketing
Ernie Munoz Ernie Munoz's Advanced Cardiovascular Systems Experience 1989 - 1994
Job Director Clinical Services at Topera
Industry Medical Devices
Experience
Topera 2011 - Present
Stereotaxis September 2010 - August 2011
Stereotaxis 2009 - September 2010
Stereotaxis 2006 - 2009
Stereotaxis 2005 - 2006
Stereotaxis 2004 - 2005
Intraluminal Therapeutics 2002 - 2004
Perclose (Abbott Vascular) 1997 - 2002
Ventritex Inc, 1994 - 1997
Advanced Cardiovascular Systems 1989 - 1994
Skills
Cardiology, Medical Devices, Capital Equipment, Clinical Research, Operating Room, Project Management, Interventional..., Cath Lab, Interventional Radiology, Surgery, Vascular, Disposables, Medical Imaging
Education
Grossmont College 1980 — 1985
Cardiovascular Technology
Topera 2011 - Present
Stereotaxis September 2010 - August 2011
Stereotaxis 2009 - September 2010
Stereotaxis 2006 - 2009
Stereotaxis 2005 - 2006
Stereotaxis 2004 - 2005
Intraluminal Therapeutics 2002 - 2004
Perclose (Abbott Vascular) 1997 - 2002
Ventritex Inc, 1994 - 1997
Advanced Cardiovascular Systems 1989 - 1994
Skills
Cardiology, Medical Devices, Capital Equipment, Clinical Research, Operating Room, Project Management, Interventional..., Cath Lab, Interventional Radiology, Surgery, Vascular, Disposables, Medical Imaging
Education
Grossmont College 1980 — 1985
Cardiovascular Technology
Dwight Mitchell Dwight Mitchell's Advanced Cardiovascular Systems Experience September 1988 - October 1993
Job Sales Representative at Merit Medical Systems, Inc.
Industry Medical Devices
Experience
Merit Medical Systems, Inc. June 2011 - Present
BIOTRONIK November 2009 - June 2011
Procter & Gamble July 1999 - June 2009
St. Jude Medical June 1994 - June 1999
Advanced Cardiovascular Systems September 1988 - October 1993
Skills
Cardiology, Urology, OB/GYN, Gastroenterology, Managed Care, Hospitals, Endocrinology, Rheumatology, Interventional Radiology, Sales, Management, Contract Negotiation, Pharmaceutical Sales, Tachycardia Certified, Selling, Medical Devices, Surgeons, Capital Equipment
Education
North Carolina Agricultural and Technical State University
BS, Economics/Agri-Business
Merit Medical Systems, Inc. June 2011 - Present
BIOTRONIK November 2009 - June 2011
Procter & Gamble July 1999 - June 2009
St. Jude Medical June 1994 - June 1999
Advanced Cardiovascular Systems September 1988 - October 1993
Skills
Cardiology, Urology, OB/GYN, Gastroenterology, Managed Care, Hospitals, Endocrinology, Rheumatology, Interventional Radiology, Sales, Management, Contract Negotiation, Pharmaceutical Sales, Tachycardia Certified, Selling, Medical Devices, Surgeons, Capital Equipment
Education
North Carolina Agricultural and Technical State University
BS, Economics/Agri-Business
Dan Kasprzyk's Advanced Cardiovascular Systems Experience 1987 - 1990
Job President & CEO, CoFounder at Symple Surgical, Inc.
Industry Medical Devices
Experience
Symple Surgical Inc. November 2012 - Present
Machine Solutions, Inc. April 2000 - October 2014
W. L. Gore & Associates 1997 - 2000
B. Braun Medical 1993 - 1997
Spectranetics 1990 - 1993
Advanced Cardiovascular Systems 1987 - 1990
ACS (now Guidant) 1987 - 1990
Medex, Inc. 1986 - 1987
Skills
Medical Devices, Business Development, Commercialization, Biomedical Engineering, R&D, Start-up Ventures, Product Innovation, Product Launch, Manufacturing, Product Development, FDA, Design Control, Start-ups, Capital Equipment, Mergers & Acquisitions, Strategic Partnerships, Vascular, ISO 13485
Education
Arizona State University 1981 — 1985
B.S.E, Bioengineering
The University of Chicago - Booth School of Business 2008 — 2009
Executive Education
Symple Surgical Inc. November 2012 - Present
Machine Solutions, Inc. April 2000 - October 2014
W. L. Gore & Associates 1997 - 2000
B. Braun Medical 1993 - 1997
Spectranetics 1990 - 1993
Advanced Cardiovascular Systems 1987 - 1990
ACS (now Guidant) 1987 - 1990
Medex, Inc. 1986 - 1987
Skills
Medical Devices, Business Development, Commercialization, Biomedical Engineering, R&D, Start-up Ventures, Product Innovation, Product Launch, Manufacturing, Product Development, FDA, Design Control, Start-ups, Capital Equipment, Mergers & Acquisitions, Strategic Partnerships, Vascular, ISO 13485
Education
Arizona State University 1981 — 1985
B.S.E, Bioengineering
The University of Chicago - Booth School of Business 2008 — 2009
Executive Education
Jerry Bloomfield Jerry Bloomfield's Advanced Cardiovascular Systems Experience 1989 - 1997
Job Director, Quality Assurance at Dexcom
Industry Medical Devices
Experience
Dexcom October 2010 - Present
Sequenom, Inc. October 2009 - October 2010
PhotoThera, Inc. 2008 - 2008
Guidant/Abbott Vascular Devices 2000 - 2008
Advanced Cardiovascular Systems 1989 - 1997
Skills
Design Control, FDA, Medical Devices, ISO 13485, V&V, Validation, ISO 14971, Quality System, Quality Control, GMP, Biotechnology, Biomedical Engineering, Regulatory Affairs, ISO, Product Development, Design of Experiments, Sop, Quality Assurance, Root Cause Analysis, R&D, 21 CFR Part 11, CAPA, Quality Auditing, Technology Transfer, Change Control, SPC, Calibration, FMEA, CQA, GLP, Supplier Quality, CE marking
Education
University of Oregon
BS, Chemistry
University of Redlands
MA, Management
Dexcom October 2010 - Present
Sequenom, Inc. October 2009 - October 2010
PhotoThera, Inc. 2008 - 2008
Guidant/Abbott Vascular Devices 2000 - 2008
Advanced Cardiovascular Systems 1989 - 1997
Skills
Design Control, FDA, Medical Devices, ISO 13485, V&V, Validation, ISO 14971, Quality System, Quality Control, GMP, Biotechnology, Biomedical Engineering, Regulatory Affairs, ISO, Product Development, Design of Experiments, Sop, Quality Assurance, Root Cause Analysis, R&D, 21 CFR Part 11, CAPA, Quality Auditing, Technology Transfer, Change Control, SPC, Calibration, FMEA, CQA, GLP, Supplier Quality, CE marking
Education
University of Oregon
BS, Chemistry
University of Redlands
MA, Management
David Brayton's Advanced Cardiovascular Systems Experience July 1992 - August 1993
Job Director, Legal at Novartis
Industry Pharmaceuticals
Experience
Novartis April 2015 - Present
Axiom January 2013 - January 2015
Bio-Rad Laboratories August 2007 - July 2012
Brayton Furniture Crafts June 2004 - July 2007
Medtronic Vascular October 1996 - January 2004
San Diego District Attorney's Office June 1995 - July 1996
Advanced Cardiovascular Systems July 1992 - August 1993
Advanced Cardiovascular Systems January 1991 - June 1992
General Motors July 1987 - September 1990
Education
University of San Diego School of Law 1993 — 1996
JD, Law
Kettering University 1987 — 1992
BSME, Mechanical Engineering
Troy Athens 1983 — 1987
Novartis April 2015 - Present
Axiom January 2013 - January 2015
Bio-Rad Laboratories August 2007 - July 2012
Brayton Furniture Crafts June 2004 - July 2007
Medtronic Vascular October 1996 - January 2004
San Diego District Attorney's Office June 1995 - July 1996
Advanced Cardiovascular Systems July 1992 - August 1993
Advanced Cardiovascular Systems January 1991 - June 1992
General Motors July 1987 - September 1990
Education
University of San Diego School of Law 1993 — 1996
JD, Law
Kettering University 1987 — 1992
BSME, Mechanical Engineering
Troy Athens 1983 — 1987
Daniel Dewar Daniel Dewar's Advanced Cardiovascular Systems Experience 1984 - 2004
Job Packaging Engineer at DePuy Synthes
Industry Medical Devices
Experience
DePuy Synthes March 2006 - Present
Advanced Cardiovascular Systems 1984 - 2004
Skills
Packaging, Medical Devices, FDA, Packaging Engineering, CAPA, Design of Experiments, Validation, R&D, Minitab, Quality System, Product Launch, FMEA, Lean Manufacturing, Cross-functional Team..., Manufacturing, Injection Molding, Product Development, Manufacturing..., Six Sigma, Continuous Improvement
Education
Kettering University 1986 — 1989
Master of Science (MS), Manufacturing Mgt, Passing
Michigan State University 1973 — 1977
Bachelor of Science (BS), Packaging, Passing
Wayne State University 1972 — 1973
No, Pre med, No
Farmington HS 1970 — 1972
Yes, 2.8
DePuy Synthes March 2006 - Present
Advanced Cardiovascular Systems 1984 - 2004
Skills
Packaging, Medical Devices, FDA, Packaging Engineering, CAPA, Design of Experiments, Validation, R&D, Minitab, Quality System, Product Launch, FMEA, Lean Manufacturing, Cross-functional Team..., Manufacturing, Injection Molding, Product Development, Manufacturing..., Six Sigma, Continuous Improvement
Education
Kettering University 1986 — 1989
Master of Science (MS), Manufacturing Mgt, Passing
Michigan State University 1973 — 1977
Bachelor of Science (BS), Packaging, Passing
Wayne State University 1972 — 1973
No, Pre med, No
Farmington HS 1970 — 1972
Yes, 2.8
Paul Stasi Paul Stasi's Advanced Cardiovascular Systems Experience 1983 - 1994
Job Sr Program Product Manager at Fairchild Imaging
Industry Medical Devices
Experience
Fairchild Imaging January 2014 - Present
Freeslate August 2013 - December 2013
Johnson & Johnson - Cordis February 2013 - July 2013
Applied Materials January 2011 - May 2012
ev3 May 2009 - May 2010
Discus 2006 - 2009
Applied Materials 2003 - 2007
KLA-Tencor January 1998 - September 2003
Boston Scientific January 1995 - January 1998
Advanced Cardiovascular Systems 1983 - 1994
Skills
Program Management, Project Management, Cross-functional Team..., Medical Devices, Product Development, Manufacturing, Quality Assurance, Continuous Improvement, Start-ups, R&D, Process Engineering, Strategy, Testing, FDA, Semiconductors, Electronics, Product Management, Engineering Management, CAPA, Product Launch, Engineering, Mergers & Acquisitions, Validation, Root Cause Analysis, Management, Quality Management, Quality System, Design for Manufacturing, Design Control, ISO 13485, Team Leadership, GMP, FMEA, SPC, Leadership, Lean Manufacturing, Quality Control, Six Sigma, Process Simulation, Supplier Quality, V&V, Change Management, ISO, DMAIC, Commercialization, Product Lifecycle..., ISO 14971, Project Planning, Manufacturing..., Design of Experiments
Education
University of Arizona
Master of Science (M.S.), Medical - Rehabilitation
Fairchild Imaging January 2014 - Present
Freeslate August 2013 - December 2013
Johnson & Johnson - Cordis February 2013 - July 2013
Applied Materials January 2011 - May 2012
ev3 May 2009 - May 2010
Discus 2006 - 2009
Applied Materials 2003 - 2007
KLA-Tencor January 1998 - September 2003
Boston Scientific January 1995 - January 1998
Advanced Cardiovascular Systems 1983 - 1994
Skills
Program Management, Project Management, Cross-functional Team..., Medical Devices, Product Development, Manufacturing, Quality Assurance, Continuous Improvement, Start-ups, R&D, Process Engineering, Strategy, Testing, FDA, Semiconductors, Electronics, Product Management, Engineering Management, CAPA, Product Launch, Engineering, Mergers & Acquisitions, Validation, Root Cause Analysis, Management, Quality Management, Quality System, Design for Manufacturing, Design Control, ISO 13485, Team Leadership, GMP, FMEA, SPC, Leadership, Lean Manufacturing, Quality Control, Six Sigma, Process Simulation, Supplier Quality, V&V, Change Management, ISO, DMAIC, Commercialization, Product Lifecycle..., ISO 14971, Project Planning, Manufacturing..., Design of Experiments
Education
University of Arizona
Master of Science (M.S.), Medical - Rehabilitation
Olin Palmer Olin Palmer's Advanced Cardiovascular Systems Experience 1989 - 1996
Job Medical Device Entrepreneur
Industry Medical Devices
Experience
BioCardia August 2009 - August 2015
Neurofluidics April 2008 - July 2013
BioCardia September 2006 - April 2008
Self-employed August 2003 - October 2006
Sadra Medical July 2005 - April 2006
NeuroPace 2006 - 2006
Guidant - Compass, Business Development Group May 1998 - August 2003
Medtronic MIS (Micro Interventional Systems) 1996 - 1998
Advanced Cardiovascular Systems 1989 - 1996
Skills
Medical Devices, R&D, Product Development, V&V, Design Control, ISO 13485, FDA, Manufacturing, Product Design, Lean Manufacturing, Biomedical Engineering, Engineering, Cross-functional Team..., Solidworks, Start-ups, Design for Manufacturing, Design of Experiments, Drug Delivery, Quality System, Biotechnology, Validation, ISO 14971, Commercialization, CAPA, Product Launch, Testing, FMEA, Continuous Improvement, Process Simulation, ISO, GMP, Lifesciences, Process Engineering, Injection Molding, Manufacturing..., Root Cause Analysis, Market Development, Manufacturing Operations, Quality Assurance, SPC, Regulatory Affairs, Quality Control, Quality Management, Supplier Quality, Engineering Management, Six Sigma, Technology Transfer, Life Sciences, SolidWorks
Education
Columbia University - Columbia Business School
MBA, Entrepreneurship/Entrepreneurial Studies
San Diego State University-California State University
BSME, Mechanical Engieering
University of California, Berkeley - Walter A. Haas School of Business
Master of Business Administration (MBA), Entrepreneurship
BioCardia August 2009 - August 2015
Neurofluidics April 2008 - July 2013
BioCardia September 2006 - April 2008
Self-employed August 2003 - October 2006
Sadra Medical July 2005 - April 2006
NeuroPace 2006 - 2006
Guidant - Compass, Business Development Group May 1998 - August 2003
Medtronic MIS (Micro Interventional Systems) 1996 - 1998
Advanced Cardiovascular Systems 1989 - 1996
Skills
Medical Devices, R&D, Product Development, V&V, Design Control, ISO 13485, FDA, Manufacturing, Product Design, Lean Manufacturing, Biomedical Engineering, Engineering, Cross-functional Team..., Solidworks, Start-ups, Design for Manufacturing, Design of Experiments, Drug Delivery, Quality System, Biotechnology, Validation, ISO 14971, Commercialization, CAPA, Product Launch, Testing, FMEA, Continuous Improvement, Process Simulation, ISO, GMP, Lifesciences, Process Engineering, Injection Molding, Manufacturing..., Root Cause Analysis, Market Development, Manufacturing Operations, Quality Assurance, SPC, Regulatory Affairs, Quality Control, Quality Management, Supplier Quality, Engineering Management, Six Sigma, Technology Transfer, Life Sciences, SolidWorks
Education
Columbia University - Columbia Business School
MBA, Entrepreneurship/Entrepreneurial Studies
San Diego State University-California State University
BSME, Mechanical Engieering
University of California, Berkeley - Walter A. Haas School of Business
Master of Business Administration (MBA), Entrepreneurship
Derrick Sung Derrick Sung's Advanced Cardiovascular Systems Experience 1992 - 1992
Job Executive Vice President, Strategy & Corporate Development at iRhythm Technologies, Inc.
Industry Medical Devices
Experience
iRhythm Technologies, Inc. May 2015 - Present
Sanford C. Bernstein February 2008 - April 2015
Boston Scientific 2004 - 2008
The Boston Consulting Group 2000 - 2004
Guidant, Devices for Vascular Intervention 1994 - 1995
Nellcor 1993 - 1993
Advanced Cardiovascular Systems 1992 - 1992
Education
University of California, San Diego 1995 — 2001
Ph.D., Bioengineering
San Diego State University-California State University 1998 — 1999
MBA
Stanford University 1990 — 1994
B.S., Mechanical Engineering
iRhythm Technologies, Inc. May 2015 - Present
Sanford C. Bernstein February 2008 - April 2015
Boston Scientific 2004 - 2008
The Boston Consulting Group 2000 - 2004
Guidant, Devices for Vascular Intervention 1994 - 1995
Nellcor 1993 - 1993
Advanced Cardiovascular Systems 1992 - 1992
Education
University of California, San Diego 1995 — 2001
Ph.D., Bioengineering
San Diego State University-California State University 1998 — 1999
MBA
Stanford University 1990 — 1994
B.S., Mechanical Engineering
Ken Goodman Ken Goodman's Advanced Cardiovascular Systems Experience 1987 - 1990
Job Medical Device Project Engineer & Manager
Industry Medical Devices
Experience
TeamPraxis December 2011 - June 2014
Micromedics December 2007 - June 2011
Boston Scientific 2006 - 2007
Aran R&D 2004 - 2006
MEL, Medical Enterprises Ltd. 2001 - 2004
Biometrix 1999 - 2001
Interventional Innovations Corp 1996 - 1997
Scimed 1990 - 1997
Advanced Cardiovascular Systems 1987 - 1990
Education
Kettering University 1985 — 1990
BS, Mechanical Engineering
Lane Technical High School
TeamPraxis December 2011 - June 2014
Micromedics December 2007 - June 2011
Boston Scientific 2006 - 2007
Aran R&D 2004 - 2006
MEL, Medical Enterprises Ltd. 2001 - 2004
Biometrix 1999 - 2001
Interventional Innovations Corp 1996 - 1997
Scimed 1990 - 1997
Advanced Cardiovascular Systems 1987 - 1990
Education
Kettering University 1985 — 1990
BS, Mechanical Engineering
Lane Technical High School
Esselstein Robert's Advanced Cardiovascular Systems Experience 1983 - 1994
Job Facilites Project Consultant at Consultant
Industry Medical Devices
Experience
Consultant April 2005 - Present
Obalon Therapeutics, Inc. November 2011 - December 2014
The BE Group - Facilties Consulting April 2005 - December 2011
Guidant (Formerly Advanced Cardiovascular Systems November 1983 - September 2004
Advanced Cardiovascular Systems 1983 - 1994
General Motors June 1968 - October 1983
Skills
Medical Devices, FDA, Cross-functional Team..., ISO 13485, Manufacturing, Quality System, R&D, CAPA, Product Development, Validation
Education
Kettering University 1986 — 1989
MSMM
Kettering University 1968 — 1973
BSME
Boston University Questrom School of Business
Executive
Consultant April 2005 - Present
Obalon Therapeutics, Inc. November 2011 - December 2014
The BE Group - Facilties Consulting April 2005 - December 2011
Guidant (Formerly Advanced Cardiovascular Systems November 1983 - September 2004
Advanced Cardiovascular Systems 1983 - 1994
General Motors June 1968 - October 1983
Skills
Medical Devices, FDA, Cross-functional Team..., ISO 13485, Manufacturing, Quality System, R&D, CAPA, Product Development, Validation
Education
Kettering University 1986 — 1989
MSMM
Kettering University 1968 — 1973
BSME
Boston University Questrom School of Business
Executive
Jim Woodward's Advanced Cardiovascular Systems Experience September 1981 - March 1986
Job Partner at Technology Commercialization Group
Industry Medical Devices
Experience
Technology Commercialization Group (TCG) January 2009 - Present
Eykona Medical US January 2012 - January 2013
Woodward Advisors LLC June 2007 - December 2008
Encelle, Inc. July 1996 - May 2007
Accordant Health Services 1994 - 1995
Aprex Corporation 1992 - 1993
Cardiometrics, Inc. 1986 - 1991
Advanced Cardiovascular Systems September 1981 - March 1986
McKinsey & Company 1975 - 1980
Skills
Medical Devices, Mergers, Start-ups, Strategic Planning, Entrepreneur, Business Planning, Business Strategy, Entrepreneurship, Contract Negotiation, Mergers & Acquisitions, Product Development, Marketing Strategy, Commercialization, Strategy, Business Development, Analytics, Corporate Development, Due Diligence, Cross-functional Team..., Strategic Partnerships, Competitive Analysis, Private Equity, Product Management, Executive Management, Biotechnology, International Business, Product Launch, Market Development, Market Analysis, Global Marketing, P&L Management, Product Marketing, Acquisition Integration
Education
Stanford University Graduate School of Business 1973 — 1975
MBA
Princeton University 1966 — 1970
AB, Economics
Technology Commercialization Group (TCG) January 2009 - Present
Eykona Medical US January 2012 - January 2013
Woodward Advisors LLC June 2007 - December 2008
Encelle, Inc. July 1996 - May 2007
Accordant Health Services 1994 - 1995
Aprex Corporation 1992 - 1993
Cardiometrics, Inc. 1986 - 1991
Advanced Cardiovascular Systems September 1981 - March 1986
McKinsey & Company 1975 - 1980
Skills
Medical Devices, Mergers, Start-ups, Strategic Planning, Entrepreneur, Business Planning, Business Strategy, Entrepreneurship, Contract Negotiation, Mergers & Acquisitions, Product Development, Marketing Strategy, Commercialization, Strategy, Business Development, Analytics, Corporate Development, Due Diligence, Cross-functional Team..., Strategic Partnerships, Competitive Analysis, Private Equity, Product Management, Executive Management, Biotechnology, International Business, Product Launch, Market Development, Market Analysis, Global Marketing, P&L Management, Product Marketing, Acquisition Integration
Education
Stanford University Graduate School of Business 1973 — 1975
MBA
Princeton University 1966 — 1970
AB, Economics
Dino Donze's Advanced Cardiovascular Systems Experience 1987 - 1994
Job Senior Territory manager at AngioScore
Industry Medical Devices
Experience
Spectranetics July 2014 - Present
AngioScore October 2011 - Present
Abbott Vascular September 1987 - October 2011
Advanced Cardiovascular Systems 1987 - 1994
Ochsner Clinic Foundation November 1980 - March 1987
Skills
Account Management, Vascular, Medical Devices, Clinical Research, Cath Lab, Interventional Radiology, Cardiology, Interventional..., Neurology, Surgeons, Stents, Capital Equipment, Sales Operations, Operating Room, Vascular Surgery, Product Launch, Healthcare, Market Development, Disposables, Commercialization, Medical Sales, Capital Equipment Sales, Urology, Cardiac Surgery, Surgical Instruments, Catheters, Radiology
Education
Ochsner School of Allied health 1978 — 1980
Registered Radiologic Technologist, Radiologic Technology
Louisiana State University and Agricultural and Mechanical College 1976 — 1977
Spectranetics July 2014 - Present
AngioScore October 2011 - Present
Abbott Vascular September 1987 - October 2011
Advanced Cardiovascular Systems 1987 - 1994
Ochsner Clinic Foundation November 1980 - March 1987
Skills
Account Management, Vascular, Medical Devices, Clinical Research, Cath Lab, Interventional Radiology, Cardiology, Interventional..., Neurology, Surgeons, Stents, Capital Equipment, Sales Operations, Operating Room, Vascular Surgery, Product Launch, Healthcare, Market Development, Disposables, Commercialization, Medical Sales, Capital Equipment Sales, Urology, Cardiac Surgery, Surgical Instruments, Catheters, Radiology
Education
Ochsner School of Allied health 1978 — 1980
Registered Radiologic Technologist, Radiologic Technology
Louisiana State University and Agricultural and Mechanical College 1976 — 1977
Susan Goodman's Advanced Cardiovascular Systems Experience 1988 - 1990
Job Attorney at Mesch, Clark & Rothschild, LLC
Industry Hospital & Health Care
Experience
Mesch, Clark & Rothschild, LLC July 2013 - Present
Ascension Health December 2012 - June 2013
Ascension Health June 2011 - December 2012
Carondelet Health Network November 2009 - May 2011
St. Mary's Hospital January 2008 - November 2009
Boston Scientific January 2007 - December 2007
St. Jude Medical May 2006 - January 2007
Guidant April 2001 - May 2006
Chandler and Udall May 2000 - April 2001
Advanced Cardiovascular Systems 1988 - 1990
Skills
Training, Nursing, Management, Hospitals, Healthcare, Managed Care, Catheters, Critical Care, Clinical Research, Medical Devices, HIPAA, Contract Negotiation, Cross-functional Team..., Healthcare Industry, Leadership, Physician Relations, Strategic Planning, Process Improvement, Informatics, Team Building, Sales, Data Analysis, Revenue Cycle, Radiology, Healthcare Management, EMR, Surgery
Education
University of Arizona, James E. Rogers College of Law 1995 — 1998
Doctor of Law (J.D.)
University of Phoenix 1990 — 1992
B.S.B.A., Business
Bronson Methodist Hospital School of Nursing 1982 — 1985
RN Diploma, Nursing
Mesch, Clark & Rothschild, LLC July 2013 - Present
Ascension Health December 2012 - June 2013
Ascension Health June 2011 - December 2012
Carondelet Health Network November 2009 - May 2011
St. Mary's Hospital January 2008 - November 2009
Boston Scientific January 2007 - December 2007
St. Jude Medical May 2006 - January 2007
Guidant April 2001 - May 2006
Chandler and Udall May 2000 - April 2001
Advanced Cardiovascular Systems 1988 - 1990
Skills
Training, Nursing, Management, Hospitals, Healthcare, Managed Care, Catheters, Critical Care, Clinical Research, Medical Devices, HIPAA, Contract Negotiation, Cross-functional Team..., Healthcare Industry, Leadership, Physician Relations, Strategic Planning, Process Improvement, Informatics, Team Building, Sales, Data Analysis, Revenue Cycle, Radiology, Healthcare Management, EMR, Surgery
Education
University of Arizona, James E. Rogers College of Law 1995 — 1998
Doctor of Law (J.D.)
University of Phoenix 1990 — 1992
B.S.B.A., Business
Bronson Methodist Hospital School of Nursing 1982 — 1985
RN Diploma, Nursing
Tracy Maahs's Advanced Cardiovascular Systems Experience 1987 - 1995
Job Chief Technology Officer at USGI Medical
Industry Medical Devices
Experience
USGI Medical April 2012 - Present
USGI Medical June 2005 - April 2012
Volcano Corporation 2000 - 2003
Embol-X 1997 - 2000
GUIDANT CORPORATION 1991 - 1995
Advanced Cardiovascular Systems 1987 - 1995
Skills
Medical Devices
Education
Kettering University 1987 — 1991
Bachelor of Science (BS), Mechanical Engineering
USGI Medical April 2012 - Present
USGI Medical June 2005 - April 2012
Volcano Corporation 2000 - 2003
Embol-X 1997 - 2000
GUIDANT CORPORATION 1991 - 1995
Advanced Cardiovascular Systems 1987 - 1995
Skills
Medical Devices
Education
Kettering University 1987 — 1991
Bachelor of Science (BS), Mechanical Engineering
Judi Lum's Advanced Cardiovascular Systems Experience 1986 - 1989
Job Executive Management
Industry Nonprofit Organization Management
Experience
E2 Consulting 2007 - Present
Coyote Point Museum for Environmental Education 2005 - 2006
StemCells, Inc. 2004 - 2005
Inhale Therapeutic Systems 1996 - 1998
Soane Technologies 1995 - 1996
GenPharm International 1993 - 1995
Raychem Corporation 1989 - 1993
Advanced Cardiovascular Systems 1986 - 1989
Crocker National Bank 1981 - 1984
Skills
Strategic Planning, Management Consulting, Start-ups, Strategy, Corporate Development, Program Management, Business Strategy, Business Development, Non-profit Leadership, Strategic Partnerships, Financial Modeling, Financial Analysis, Lean Operations, Interim Management, Change Management, Turn Around Management, Organizational..., Nonprofits, Management, Analysis, Finance, Executive Management, Consulting, Mergers & Acquisitions, Venture Capital, Entrepreneurship, Private Equity, Due Diligence, Valuation
Education
Stanford University Graduate School of Business 1984 — 1986
MBA, Finance
Stanford University 1978 — 1981
BA, Economics
E2 Consulting 2007 - Present
Coyote Point Museum for Environmental Education 2005 - 2006
StemCells, Inc. 2004 - 2005
Inhale Therapeutic Systems 1996 - 1998
Soane Technologies 1995 - 1996
GenPharm International 1993 - 1995
Raychem Corporation 1989 - 1993
Advanced Cardiovascular Systems 1986 - 1989
Crocker National Bank 1981 - 1984
Skills
Strategic Planning, Management Consulting, Start-ups, Strategy, Corporate Development, Program Management, Business Strategy, Business Development, Non-profit Leadership, Strategic Partnerships, Financial Modeling, Financial Analysis, Lean Operations, Interim Management, Change Management, Turn Around Management, Organizational..., Nonprofits, Management, Analysis, Finance, Executive Management, Consulting, Mergers & Acquisitions, Venture Capital, Entrepreneurship, Private Equity, Due Diligence, Valuation
Education
Stanford University Graduate School of Business 1984 — 1986
MBA, Finance
Stanford University 1978 — 1981
BA, Economics
Jennifer (Sample) Moore's Advanced Cardiovascular Systems Experience 1994 - 1995
Job Clinical Research Consultant
Industry Medical Devices
Experience
Jennifer Moore Consulting August 2011 - Present
Northwest Clinical Research Group August 2012 - March 2013
ArthroCare Corporation 2005 - August 2011
Vascular Architects 2001 - 2005
Boston Scientific 2000 - 2001
Guidant 1999 - 2001
Norian Corporation 1995 - 1999
Advanced Cardiovascular Systems 1994 - 1995
Skills
Medical Devices, FDA, CTMS, Clinical Monitoring, Clinical Trials, Clinical Research, EDC, CAPA, Clinical Data Management, Clinical Development, ICH-GCP, ISO 13485, Oncology, V&V, Urology, Quality Assurance, Quality System, Regulatory Submissions, GCP, Orthopedic, Pharmaceutical Industry, CRO, Validation, Protocol, Neurology, 21 CFR Part 11, GMP, Biotechnology, Sop, Quality Control
Education
San Jose State University 1987 — 1996
Bachelor of Science (B.S.), Health Science
Jennifer Moore Consulting August 2011 - Present
Northwest Clinical Research Group August 2012 - March 2013
ArthroCare Corporation 2005 - August 2011
Vascular Architects 2001 - 2005
Boston Scientific 2000 - 2001
Guidant 1999 - 2001
Norian Corporation 1995 - 1999
Advanced Cardiovascular Systems 1994 - 1995
Skills
Medical Devices, FDA, CTMS, Clinical Monitoring, Clinical Trials, Clinical Research, EDC, CAPA, Clinical Data Management, Clinical Development, ICH-GCP, ISO 13485, Oncology, V&V, Urology, Quality Assurance, Quality System, Regulatory Submissions, GCP, Orthopedic, Pharmaceutical Industry, CRO, Validation, Protocol, Neurology, 21 CFR Part 11, GMP, Biotechnology, Sop, Quality Control
Education
San Jose State University 1987 — 1996
Bachelor of Science (B.S.), Health Science
Keif Fitzgerald's Advanced Cardiovascular Systems Experience February 1990 - March 1994
Job Sr. Manager, PHP Program at Thoratec
Industry Medical Devices
Experience
Thoratec June 2010 - Present
Abbott Vascular Devices October 1995 - August 2010
EP Technologies March 1995 - October 1995
Microflow Analytical March 1994 - March 1995
Advanced Cardiovascular Systems February 1990 - March 1994
Education
Santa Clara University 1991 — 1993
MBA
San Jose State University 1988 — 1990
BS, Material Engineering
California State University-East Bay 1983 — 1984
Credential, Science Teaching
University of California, Davis 1980 — 1983
BS, Food Biochemistry
Thoratec June 2010 - Present
Abbott Vascular Devices October 1995 - August 2010
EP Technologies March 1995 - October 1995
Microflow Analytical March 1994 - March 1995
Advanced Cardiovascular Systems February 1990 - March 1994
Education
Santa Clara University 1991 — 1993
MBA
San Jose State University 1988 — 1990
BS, Material Engineering
California State University-East Bay 1983 — 1984
Credential, Science Teaching
University of California, Davis 1980 — 1983
BS, Food Biochemistry
Ken Osborn's Advanced Cardiovascular Systems Experience July 1989 - June 1993
Job VP Operations at Stryker
Industry Medical Devices
Experience
Stryker August 2012 - Present
Boston Scientific April 2004 - August 2012
Precision Vascular November 2000 - April 2004
Pinpoint Therapeutics August 1999 - July 2000
Guidant December 1997 - July 1999
Endovascular Technologies June 1993 - December 1997
Advanced Cardiovascular Systems July 1989 - June 1993
Education
Oregon State University
Bachelor of Science (BS), Industrial Engineering
Stryker August 2012 - Present
Boston Scientific April 2004 - August 2012
Precision Vascular November 2000 - April 2004
Pinpoint Therapeutics August 1999 - July 2000
Guidant December 1997 - July 1999
Endovascular Technologies June 1993 - December 1997
Advanced Cardiovascular Systems July 1989 - June 1993
Education
Oregon State University
Bachelor of Science (BS), Industrial Engineering
Earle Canty's Advanced Cardiovascular Systems Experience 1980 - 1985
Job Sr. Director, Regulatory Affairs at Intuitive Surgical
Industry Medical Devices
Experience
Intuitive Surgical April 2012 - Present
NovoStent March 2007 - April 2012
Cardica, Inc. 2006 - 2007
Conor Medsystems 2004 - 2006
Conor Medsystems 2004 - 2006
Conor Medsystems (Cordis West, J&J) 2004 - 2006
Cardiac Pathways 1996 - 1998
Ventritex 1987 - 1994
Advanced Cardiovascular Systems 1980 - 1985
Skills
Design Control, Medical Devices, PMA, FDA, ISO 13485, CAPA, Quality System, V&V
Education
Stanford University 1970 — 1975
Master's degree, Biological Sciences
Intuitive Surgical April 2012 - Present
NovoStent March 2007 - April 2012
Cardica, Inc. 2006 - 2007
Conor Medsystems 2004 - 2006
Conor Medsystems 2004 - 2006
Conor Medsystems (Cordis West, J&J) 2004 - 2006
Cardiac Pathways 1996 - 1998
Ventritex 1987 - 1994
Advanced Cardiovascular Systems 1980 - 1985
Skills
Design Control, Medical Devices, PMA, FDA, ISO 13485, CAPA, Quality System, V&V
Education
Stanford University 1970 — 1975
Master's degree, Biological Sciences
jeff jarvela's Advanced Cardiovascular Systems Experience 1989 - 1992
Job Medical Device Executive; turning ideas into products for clinical trials/NPI (disposables/reusables or implantables).
Industry Medical Devices
Experience
Jan Medical 2004 - 2008
Ovion Inc. 2003 - 2004
Jarvela Consulting June 1998 - February 2002
Endo Vascular Technologies (EVT) 1992 - 1998
Advanced Cardiovascular Systems 1989 - 1992
Skills
Goal Setting, Goal Oriented, Highly resourceful, Positive Work..., Setting Priorities, Team Building, Hiring Practices, Problem Solving, Presentations, Project Management, Close Attention to..., Insightful, Evaluating, Communication, Continuous Improvement, MS Project, PowerPoint, Microsoft Office, Sense of Humor, Tolerance, Sincere, Vascular, Medical Devices, Commercialization, Leadership, R&D, ISO 13485, Start-ups, Product Development, FDA, Product Launch, Cross-functional Team..., Manufacturing, Management
Education
Mott Community College 1975 — 1977
Associate of Applied Science, Electronics Technology
Kettering University
Bachelor of Science Industrial Engineering, Quality Control, Maunfacturing, Human Factors, Methods, Operations Research, Business Administration
Jan Medical 2004 - 2008
Ovion Inc. 2003 - 2004
Jarvela Consulting June 1998 - February 2002
Endo Vascular Technologies (EVT) 1992 - 1998
Advanced Cardiovascular Systems 1989 - 1992
Skills
Goal Setting, Goal Oriented, Highly resourceful, Positive Work..., Setting Priorities, Team Building, Hiring Practices, Problem Solving, Presentations, Project Management, Close Attention to..., Insightful, Evaluating, Communication, Continuous Improvement, MS Project, PowerPoint, Microsoft Office, Sense of Humor, Tolerance, Sincere, Vascular, Medical Devices, Commercialization, Leadership, R&D, ISO 13485, Start-ups, Product Development, FDA, Product Launch, Cross-functional Team..., Manufacturing, Management
Education
Mott Community College 1975 — 1977
Associate of Applied Science, Electronics Technology
Kettering University
Bachelor of Science Industrial Engineering, Quality Control, Maunfacturing, Human Factors, Methods, Operations Research, Business Administration
Eric Penn's Advanced Cardiovascular Systems Experience 1989 - 1995
Job Retired at None
Industry Medical Devices
Experience
None January 2010 - Present
Cordis Corporation 2005 - 2007
Quintiles Consulting November 2005 - December 2006
Guidant Corp 1988 - 2004
ACS/GUIDANT 1988 - 2004
Advanced Cardiovascular Systems 1989 - 1995
Skills
Design Control, R&D, Process Simulation, FDA, CAPA, Medical Devices, V&V, ISO 13485, Validation, Quality System, 21 CFR Part 11, GMP, Regulatory Affairs
Education
Coventry University 1962 — 1967
1965
None January 2010 - Present
Cordis Corporation 2005 - 2007
Quintiles Consulting November 2005 - December 2006
Guidant Corp 1988 - 2004
ACS/GUIDANT 1988 - 2004
Advanced Cardiovascular Systems 1989 - 1995
Skills
Design Control, R&D, Process Simulation, FDA, CAPA, Medical Devices, V&V, ISO 13485, Validation, Quality System, 21 CFR Part 11, GMP, Regulatory Affairs
Education
Coventry University 1962 — 1967
1965
Ginger Graham's Advanced Cardiovascular Systems Experience 1992 - 2000
Job Healthcare Executive, CEO Coach
Industry Biotechnology
Experience
Walgreens April 2010 - Present
Genomic Health December 2008 - Present
Proteus Biomedical, Inc. November 2007 - Present
Harvard Business School October 2009 - June 2012
Amylin Pharmaceuticals 2003 - 2007
Guidant Corporation 1994 - 2003
Advanced Cardiovascular Systems 1992 - 2000
Eli Lilly September 1986 - December 1992
Elanco Products Company August 1979 - May 1984
Education
Harvard Business School 1984 — 1986
MBA, With Honors
University of Arkansas 1977 — 1979
BS, Agriculture Economics
Abilene Christian University 1974 — 1976
Pre-Veterinary Medicines
Walgreens April 2010 - Present
Genomic Health December 2008 - Present
Proteus Biomedical, Inc. November 2007 - Present
Harvard Business School October 2009 - June 2012
Amylin Pharmaceuticals 2003 - 2007
Guidant Corporation 1994 - 2003
Advanced Cardiovascular Systems 1992 - 2000
Eli Lilly September 1986 - December 1992
Elanco Products Company August 1979 - May 1984
Education
Harvard Business School 1984 — 1986
MBA, With Honors
University of Arkansas 1977 — 1979
BS, Agriculture Economics
Abilene Christian University 1974 — 1976
Pre-Veterinary Medicines
Sue Feltovich's Advanced Cardiovascular Systems Experience 1989 - 1994
Job Director, R&D Systems at Abbott Vascular
Industry Medical Devices
Experience
Abbott Vascular July 2008 - Present
Abbott Vascular 2006 - 2008
Guidant Corporation 2003 - 2006
Guidant 1999 - 2003
Guidant 1994 - 1997
Advanced Cardiovascular Systems 1989 - 1994
Zimmer 1985 - 1989
Education
University of Akron 1979 — 1984
BS, Engineering (Biomechanical)
Abbott Vascular July 2008 - Present
Abbott Vascular 2006 - 2008
Guidant Corporation 2003 - 2006
Guidant 1999 - 2003
Guidant 1994 - 1997
Advanced Cardiovascular Systems 1989 - 1994
Zimmer 1985 - 1989
Education
University of Akron 1979 — 1984
BS, Engineering (Biomechanical)
Vern Fischer's Advanced Cardiovascular Systems Experience 1988 - 1994
Job Manufacturing Engineer at Abbott Labs
Industry Medical Devices
Experience
Abbott Labs Staff Manufacturing EngineerAbbott Vascular2004 - Present
Guidant 1994 - 2006
Advanced Cardiovascular Systems 1988 - 1994
Education
Rochester Institute of Technology 2000 — 2002
Certificate, Applied Statistics
Michigan Technological University 1972 — 1980
Bachelor of Science (B.S.), Metallurgical Engineering
Abbott Labs Staff Manufacturing EngineerAbbott Vascular2004 - Present
Guidant 1994 - 2006
Advanced Cardiovascular Systems 1988 - 1994
Education
Rochester Institute of Technology 2000 — 2002
Certificate, Applied Statistics
Michigan Technological University 1972 — 1980
Bachelor of Science (B.S.), Metallurgical Engineering
Ken Wantink's Advanced Cardiovascular Systems Experience October 1989 - October 1996
Job Advisor, Manufacturing, R&D at Abbott Vascular Devices
Industry Medical Devices
Experience
Abbott Vascular Devices May 2006 - Present
Guidant October 1999 - May 2006
ACS/Guidant 1989 - 2006
Guidant October 1996 - October 1999
Advanced Cardiovascular Systems October 1989 - October 1996
Silicon Detector Corp 1987 - 1989
Bendix oceanics division 1980 - 1987
Skills
Medical Devices, R&D, Design for Manufacturing, Manufacturing..., Product Design, Manufacturing, Catheters, Engineering, Process Simulation, Troubleshooting, Rapid Prototyping, Design Control
Education
California State University-Long Beach 1975 — 1978
BS, Industrial Technology
Los Angeles Pierce College 1972 — 1975
AA, General education
Abbott Vascular Devices May 2006 - Present
Guidant October 1999 - May 2006
ACS/Guidant 1989 - 2006
Guidant October 1996 - October 1999
Advanced Cardiovascular Systems October 1989 - October 1996
Silicon Detector Corp 1987 - 1989
Bendix oceanics division 1980 - 1987
Skills
Medical Devices, R&D, Design for Manufacturing, Manufacturing..., Product Design, Manufacturing, Catheters, Engineering, Process Simulation, Troubleshooting, Rapid Prototyping, Design Control
Education
California State University-Long Beach 1975 — 1978
BS, Industrial Technology
Los Angeles Pierce College 1972 — 1975
AA, General education
Spanky Raymond's Advanced Cardiovascular Systems Experience 1993 - 1994
Job President & Owner, Consultant
Industry Medical Devices
Experience
Acclerated OrthoSolutions August 2009 - Present
O'Savage Biomechanics August 2000 - August 2009
Theken Spine 2000 - 2000
Advanced CardioVascular Systems 1993 - 1994
Skills
Solidworks, Medical Devices, Product Development, R&D, Product Design, Project Management, Pro Engineer, CAD
Education
The University of Akron 1995 — 1999
Masters, Mechanical Engineering
Biglerville High School
Biglerville High School
Acclerated OrthoSolutions August 2009 - Present
O'Savage Biomechanics August 2000 - August 2009
Theken Spine 2000 - 2000
Advanced CardioVascular Systems 1993 - 1994
Skills
Solidworks, Medical Devices, Product Development, R&D, Product Design, Project Management, Pro Engineer, CAD
Education
The University of Akron 1995 — 1999
Masters, Mechanical Engineering
Biglerville High School
Biglerville High School
Roxanne Simon's Advanced Cardiovascular Systems Experience June 1989 - August 1989
Job Sr. Project Manager at SIBONE, Inc.
Industry Medical Devices
Experience
SI-BONE, Inc. February 2013 - Present
Hantel Technologies, Inc. June 2011 - February 2013
Medtronic Spine & Biologics February 2010 - June 2011
Spinal Kinetics July 2004 - December 2009
Hantel Technologies, Inc. December 2001 - July 2004
Epicor Medical (acquired by St. Jude Medical) April 1999 - August 2001
Stellartech Research April 1993 - April 1999
Innerdyne Medical Corp. October 1991 - April 1993
Advanced Cardiovascular Systems June 1989 - August 1989
Skills
ISO 13485, Design Control, Cross-functional Team..., Product Development, Medical Devices, R&D, Strategy, Validation, Design for Manufacturing, Engineering, Quality System, Market Development, Biomedical Engineering, Manufacturing, FMEA, Root Cause Analysis, Design of Experiments, CAPA, Commercialization, FDA, Management, V&V, ISO 14971, Solidworks, Product Launch, GMP, Start-ups, Injection Molding, CE marking, Minitab
Education
University of California, Berkeley 1986 — 1991
BS, Engineering
SI-BONE, Inc. February 2013 - Present
Hantel Technologies, Inc. June 2011 - February 2013
Medtronic Spine & Biologics February 2010 - June 2011
Spinal Kinetics July 2004 - December 2009
Hantel Technologies, Inc. December 2001 - July 2004
Epicor Medical (acquired by St. Jude Medical) April 1999 - August 2001
Stellartech Research April 1993 - April 1999
Innerdyne Medical Corp. October 1991 - April 1993
Advanced Cardiovascular Systems June 1989 - August 1989
Skills
ISO 13485, Design Control, Cross-functional Team..., Product Development, Medical Devices, R&D, Strategy, Validation, Design for Manufacturing, Engineering, Quality System, Market Development, Biomedical Engineering, Manufacturing, FMEA, Root Cause Analysis, Design of Experiments, CAPA, Commercialization, FDA, Management, V&V, ISO 14971, Solidworks, Product Launch, GMP, Start-ups, Injection Molding, CE marking, Minitab
Education
University of California, Berkeley 1986 — 1991
BS, Engineering
Daniel M. Dewar's Advanced Cardiovascular Systems Experience 1984 - 2004
Job Packaging Engineer at DePuySynthes
Industry Medical Devices
Experience
DePuySynthes 2006 - Present
Avail Medical Products October 2004 - January 2006
Guidant September 1984 - August 2004
Guidant Corporation / Advanced Cardiovascular Systems 1984 - 2004
Advanced Cardiovascular Systems 1984 - 2004
IVAC December 1980 - September 1984
The Kendall Company June 1977 - December 1980
Skills
Medical Devices, Validation, Packaging, Design Control, Quality System, R&D, GMP, Packaging Engineering, Manufacturing, CAPA, Plastics, SPC, Product Development, Continuous Improvement, ISO, FDA, ISO 14971, Sterilization, Design for Manufacturing, 21 CFR Part 11, 21 CFR, FMEA, Manufacturing..., Quality Management, Injection Molding, Commercialization, Biomedical Engineering, Failure Analysis, Quality Auditing, Technology Transfer, Quality Control, Process Improvement, Regulatory Affairs, Biotechnology, Value Stream Mapping, Manufacturing Operations, DMAIC, FDA GMP, Process Simulation, 5S, Sop, Quality Assurance, Manufacturing..., Capital Equipment, Change Control, Materials, Engineering, Solidworks, Product Launch, Process Engineering
Education
Kettering University 1986 — 1989
MS, Manufacturing Management
Michigan State University 1973 — 1977
BS, Natural Resources
Wayne State University 1972 — 1973
Farmington High School 1970 — 1972
HS diploma
DePuySynthes 2006 - Present
Avail Medical Products October 2004 - January 2006
Guidant September 1984 - August 2004
Guidant Corporation / Advanced Cardiovascular Systems 1984 - 2004
Advanced Cardiovascular Systems 1984 - 2004
IVAC December 1980 - September 1984
The Kendall Company June 1977 - December 1980
Skills
Medical Devices, Validation, Packaging, Design Control, Quality System, R&D, GMP, Packaging Engineering, Manufacturing, CAPA, Plastics, SPC, Product Development, Continuous Improvement, ISO, FDA, ISO 14971, Sterilization, Design for Manufacturing, 21 CFR Part 11, 21 CFR, FMEA, Manufacturing..., Quality Management, Injection Molding, Commercialization, Biomedical Engineering, Failure Analysis, Quality Auditing, Technology Transfer, Quality Control, Process Improvement, Regulatory Affairs, Biotechnology, Value Stream Mapping, Manufacturing Operations, DMAIC, FDA GMP, Process Simulation, 5S, Sop, Quality Assurance, Manufacturing..., Capital Equipment, Change Control, Materials, Engineering, Solidworks, Product Launch, Process Engineering
Education
Kettering University 1986 — 1989
MS, Manufacturing Management
Michigan State University 1973 — 1977
BS, Natural Resources
Wayne State University 1972 — 1973
Farmington High School 1970 — 1972
HS diploma
Helen Prince's Advanced Cardiovascular Systems Experience 1994 - 1997
Job Quality Systems Consultant for Medical Devices
Industry Medical Devices
Experience
Elixir Medical August 2005 - Present
Guidant 2003 - 2004
Guidant 2000 - 2003
Advanced Cardiovascular Systems 1994 - 1997
Skills
Cross-functional Team..., Quality System, ISO 13485, ISO 14971, Validation, FDA, Medical Devices, Design Control, CAPA, FMEA, Manufacturing, V&V, Root Cause Analysis, DMAIC, R&D, Biomedical Engineering, Design of Experiments, Product Development
Education
Loughborough University 1988 — 1992
BEng, Maufacturing Engineering
Elixir Medical August 2005 - Present
Guidant 2003 - 2004
Guidant 2000 - 2003
Advanced Cardiovascular Systems 1994 - 1997
Skills
Cross-functional Team..., Quality System, ISO 13485, ISO 14971, Validation, FDA, Medical Devices, Design Control, CAPA, FMEA, Manufacturing, V&V, Root Cause Analysis, DMAIC, R&D, Biomedical Engineering, Design of Experiments, Product Development
Education
Loughborough University 1988 — 1992
BEng, Maufacturing Engineering
Tim Machold's Advanced Cardiovascular Systems Experience 1986 - 1992
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
Creag Trautman's Advanced Cardiovascular Systems Experience 1989 - 1993
Job at Shifamed, LLC
Industry Medical Devices
Experience
Kalila Medical February 2011 - Present
Acclarent April 2010 - February 2011
Corium International July 2006 - February 2010
Hansen Medical October 2005 - July 2006
ALZA Corporation July 1998 - October 2005
Prograft June 1995 - July 1998
Advanced Cardiovascular Systems 1989 - 1993
USAF 1984 - 1988
Education
Santa Clara University 1990 — 1993
MS, engineering management
Massachusetts Institute of Technology 1981 — 1984
BS, mechanical engineering
Kalila Medical February 2011 - Present
Acclarent April 2010 - February 2011
Corium International July 2006 - February 2010
Hansen Medical October 2005 - July 2006
ALZA Corporation July 1998 - October 2005
Prograft June 1995 - July 1998
Advanced Cardiovascular Systems 1989 - 1993
USAF 1984 - 1988
Education
Santa Clara University 1990 — 1993
MS, engineering management
Massachusetts Institute of Technology 1981 — 1984
BS, mechanical engineering
Tom Whalen's Advanced Cardiovascular Systems Experience 1988 - 1997
Job Chief Operating Officer at Accriva Diagnostics
Industry Medical Devices
Experience
Accriva Diagnostics March 2014 - Present
Covidien January 2009 - Present
ev3 2007 - 2008
ev3 2002 - 2006
ev3 1997 - 2002
Advanced Cardiovascular Systems 1988 - 1997
Skills
Lean Manufacturing, Manufacturing Management, Continuous Improvement, Quality Systems, Six Sigma, Manufacturing, ISO, Medical Devices, Product Development, Process Improvement, Process Engineering, Engineering, Kaizen, 5S, Change Management, Cross-functional Team..., FDA, Quality System, Manufacturing..., Quality Management, Manufacturing..., Start-ups, Supply Chain, ISO 13485, Supply Chain Management, Operational Excellence, Manufacturing Operations, Value Stream Mapping, CAPA, DMAIC, Design Control, SPC, Design of Experiments, R&D
Education
California State University-Long Beach 1977 — 1983
BS, Manufacturing Engineering
Accriva Diagnostics March 2014 - Present
Covidien January 2009 - Present
ev3 2007 - 2008
ev3 2002 - 2006
ev3 1997 - 2002
Advanced Cardiovascular Systems 1988 - 1997
Skills
Lean Manufacturing, Manufacturing Management, Continuous Improvement, Quality Systems, Six Sigma, Manufacturing, ISO, Medical Devices, Product Development, Process Improvement, Process Engineering, Engineering, Kaizen, 5S, Change Management, Cross-functional Team..., FDA, Quality System, Manufacturing..., Quality Management, Manufacturing..., Start-ups, Supply Chain, ISO 13485, Supply Chain Management, Operational Excellence, Manufacturing Operations, Value Stream Mapping, CAPA, DMAIC, Design Control, SPC, Design of Experiments, R&D
Education
California State University-Long Beach 1977 — 1983
BS, Manufacturing Engineering
Laraine Pangelina's Advanced Cardiovascular Systems Experience 1984 - 1993
Job Regulatory Affairs at MicroVention, Inc
Industry Medical Devices
Experience
MicroVention, Inc June 2009 - Present
Concentric Medical 2008 - 2009
Boston Scientific, Neurointerventional Division 2006 - 2008
Experien Group 2004 - 2006
Guidant, Endovascular Solutions 2003 - 2004
Timi3 Systems 2001 - 2003
Oratec Interventions 2000 - 2001
CardioThoracic Systems (CTS) 1997 - 2000
Boston Scientific / Target Therapeutics 1993 - 1997
Advanced Cardiovascular Systems 1984 - 1993
Skills
Medical Devices, FDA, CE marking, ISO 13485, Regulatory Affairs, CAPA, Quality System, PMA, Worldwide Regulatory...
Education
Pomona High
San Francisco State University
Bachelor's degree
MicroVention, Inc June 2009 - Present
Concentric Medical 2008 - 2009
Boston Scientific, Neurointerventional Division 2006 - 2008
Experien Group 2004 - 2006
Guidant, Endovascular Solutions 2003 - 2004
Timi3 Systems 2001 - 2003
Oratec Interventions 2000 - 2001
CardioThoracic Systems (CTS) 1997 - 2000
Boston Scientific / Target Therapeutics 1993 - 1997
Advanced Cardiovascular Systems 1984 - 1993
Skills
Medical Devices, FDA, CE marking, ISO 13485, Regulatory Affairs, CAPA, Quality System, PMA, Worldwide Regulatory...
Education
Pomona High
San Francisco State University
Bachelor's degree
Liza Hantske's Advanced Cardiovascular Systems Experience January 1995 - December 1996
Job Director, Quality Assurance, Compliance, New Product Development at Intersect Partners
Industry Medical Devices
Experience
Intersect Partners August 2012 - Present
Endologix Inc November 2010 - July 2012
CareFusion November 2009 - October 2010
Alphatec Spine August 2006 - October 2009
Alphatec Spine August 2006 - October 2009
Alphatec Spine August 2006 - October 2009
Guidant Corporation January 1997 - September 2004
Guidant Corporation September 2003 - August 2004
Advanced Cardiovascular Systems January 1995 - December 1996
Devices for Vascular Intervention August 1992 - December 1994
Skills
Start-ups, ISO 14971, Quality System, Risk Management, FDA, Manufacturing, Six Sigma, V&V, Medical Devices, Validation, CAPA, Quality Assurance, Design Control, Quality Management, FMEA, Supplier Quality, Quality Control, ISO, Iso 9000
Education
University of California, San Diego
Bachelors of Science, Biomedical Engineering
University of Phoenix
Masters, Business Administration
Intersect Partners August 2012 - Present
Endologix Inc November 2010 - July 2012
CareFusion November 2009 - October 2010
Alphatec Spine August 2006 - October 2009
Alphatec Spine August 2006 - October 2009
Alphatec Spine August 2006 - October 2009
Guidant Corporation January 1997 - September 2004
Guidant Corporation September 2003 - August 2004
Advanced Cardiovascular Systems January 1995 - December 1996
Devices for Vascular Intervention August 1992 - December 1994
Skills
Start-ups, ISO 14971, Quality System, Risk Management, FDA, Manufacturing, Six Sigma, V&V, Medical Devices, Validation, CAPA, Quality Assurance, Design Control, Quality Management, FMEA, Supplier Quality, Quality Control, ISO, Iso 9000
Education
University of California, San Diego
Bachelors of Science, Biomedical Engineering
University of Phoenix
Masters, Business Administration
John W. Thorpe's Advanced Cardiovascular Systems Experience March 1989 - September 1995
Job General Manager at ASICS Field Services, llc
Industry Construction
Experience
ASICS Field Services, llc March 2006 - Present
Guidant September 1996 - October 2004
Advanced Cardiovascular Systems March 1989 - September 1995
Skills
Team Building, Construction, Earthworks, Stormwater Management, Project Management, Budgets, Process Improvement, Leadership, Management, Strategic Planning, Microsoft Office, New Business Development, Small Business, Contract Negotiation, Account Management, Sales, Marketing Communications, Marketing Strategy, Grading, Negotiation, Customer Service, Contract Management, Business Strategy, Microsoft Word, Microsoft Excel, Social Media
Education
Wayne State University 1973 — 1974
Business
Ferris State University 1965 — 1968
AA, Biology, Business Admin.
ASICS Field Services, llc March 2006 - Present
Guidant September 1996 - October 2004
Advanced Cardiovascular Systems March 1989 - September 1995
Skills
Team Building, Construction, Earthworks, Stormwater Management, Project Management, Budgets, Process Improvement, Leadership, Management, Strategic Planning, Microsoft Office, New Business Development, Small Business, Contract Negotiation, Account Management, Sales, Marketing Communications, Marketing Strategy, Grading, Negotiation, Customer Service, Contract Management, Business Strategy, Microsoft Word, Microsoft Excel, Social Media
Education
Wayne State University 1973 — 1974
Business
Ferris State University 1965 — 1968
AA, Biology, Business Admin.
Jeanne Sellgren's Advanced Cardiovascular Systems Experience 1989 - 1990
Job IT Purchasing Columbia Forest Products
Industry Information Technology and Services
Experience
Columbia Forest Products October 2009 - Present
Guidant June 1992 - November 1997
Advanced Cardiovascular Systems 1989 - 1990
ARGOSystems, Inc. August 1983 - July 1987
Education
St. Mary's College of California 1979 — 1983
BS, Psychology/Business
Columbia Forest Products October 2009 - Present
Guidant June 1992 - November 1997
Advanced Cardiovascular Systems 1989 - 1990
ARGOSystems, Inc. August 1983 - July 1987
Education
St. Mary's College of California 1979 — 1983
BS, Psychology/Business
Jan Cadlini's Advanced Cardiovascular Systems Experience June 1983 - March 1987
Job Owner, Trainer at Jan's Pilates Fitness and Real Men Do Pilates
Industry Health, Wellness and Fitness
Experience
Jan's Pilates Fitness January 1998 - Present
Matrix Product Design/IDEO July 1991 - August 1992
NeXt Computer January 1990 - July 1991
Genesystems Computer Software January 1987 - January 1990
Advanced Cardiovascular Systems June 1983 - March 1987
Seattle Athletic Club February 1982 - July 1983
American Association of Fitness Directors in Business and Industry March 1981 - January 1982
Xerox September 1979 - January 1982
President's Council on Physical Fitness and Sports October 1980 - April 1981
Shugart Associates January 1979 - September 1979
Skills
Wellness, Lifestyle, Weight Management, Personal Coaching, Aging, Body Image, Pilates, Personal Training, Event Management, Fitness Consulting, Fitness, Management, Exercise Physiology, Sports, Weight Training, Pain Management, Physical Therapy
Education
Rael Isakowitz Pilates Master Trainer 1995 — 1997
Certification in Pilates Training, Pilates
Pacific College of Oriental Medicine 1992 — 1994
graduate study, Traditional Chinese Medicine and Chinese Herbology
Stanford University 1975 — 1979
Human Biology, Exercise Physiology
UCLA 1974 — 1975
High School Special Honors Program
Santa Monica High School 1972 — 1975
High School, College Prep
Jan's Pilates Fitness January 1998 - Present
Matrix Product Design/IDEO July 1991 - August 1992
NeXt Computer January 1990 - July 1991
Genesystems Computer Software January 1987 - January 1990
Advanced Cardiovascular Systems June 1983 - March 1987
Seattle Athletic Club February 1982 - July 1983
American Association of Fitness Directors in Business and Industry March 1981 - January 1982
Xerox September 1979 - January 1982
President's Council on Physical Fitness and Sports October 1980 - April 1981
Shugart Associates January 1979 - September 1979
Skills
Wellness, Lifestyle, Weight Management, Personal Coaching, Aging, Body Image, Pilates, Personal Training, Event Management, Fitness Consulting, Fitness, Management, Exercise Physiology, Sports, Weight Training, Pain Management, Physical Therapy
Education
Rael Isakowitz Pilates Master Trainer 1995 — 1997
Certification in Pilates Training, Pilates
Pacific College of Oriental Medicine 1992 — 1994
graduate study, Traditional Chinese Medicine and Chinese Herbology
Stanford University 1975 — 1979
Human Biology, Exercise Physiology
UCLA 1974 — 1975
High School Special Honors Program
Santa Monica High School 1972 — 1975
High School, College Prep
Craig Mar's Advanced Cardiovascular Systems Experience 1983 - 1988
Job Consulting Engineer
Industry Medical Devices
Experience
Self-employed September 2009 - Present
Acclarent 2009 - 2012
Paracor Medical April 2003 - September 2009
CEM Enterprises August 1996 - April 2003
Ventritex March 1988 - February 1994
Advanced Cardiovascular Systems 1983 - 1988
Skills
Silicone Rubber Molding..., Fatigue Testing and..., Medical Device Design, Mechanical Product..., Process Development, Machine Design, Medical Devices, Product Development, FDA, Cross-functional Team..., Process Engineering, Design Control, Manufacturing, Process Simulation, ISO 13485, Injection Molding, Testing, R&D, V&V, Biomedical Engineering, Solidworks, CAPA, Catheters, Design for Manufacturing
Education
University of California, Berkeley 1979 — 1983
Bachelor of Science (BS), Bioengineering and Biomedical Engineering
Self-employed September 2009 - Present
Acclarent 2009 - 2012
Paracor Medical April 2003 - September 2009
CEM Enterprises August 1996 - April 2003
Ventritex March 1988 - February 1994
Advanced Cardiovascular Systems 1983 - 1988
Skills
Silicone Rubber Molding..., Fatigue Testing and..., Medical Device Design, Mechanical Product..., Process Development, Machine Design, Medical Devices, Product Development, FDA, Cross-functional Team..., Process Engineering, Design Control, Manufacturing, Process Simulation, ISO 13485, Injection Molding, Testing, R&D, V&V, Biomedical Engineering, Solidworks, CAPA, Catheters, Design for Manufacturing
Education
University of California, Berkeley 1979 — 1983
Bachelor of Science (BS), Bioengineering and Biomedical Engineering
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY