Myocor Company

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Myocor Employees

Employee
Years
Job
Industry
Marc Raffe Marc Raffe Greater Minneapolis-St. Paul Area Details
Marc Raffe's Myocor Experience 1998 - 2000
Job Director, Veterinary Anesthesia and Critical Care Associates
Industry Pharmaceuticals
Experience
Veterinary Anesthesia and Critical Care Associates   September 2013 - Present
Zoetis Inc  February 2013 - August 2013
Pfizer Animal Health  March 2009 - February 2013
Pfizer Animal Health  March 2006 - March 2009
Pfizer Animal Health  July 2003 - March 2009
University of Illinois at Urbana-Champaign  March 2000 - July 2003
Myocor   1998 - 2000
University of Minnesota  July 1980 - September 1998

Skills
Pharmaceutical Industry, Biomedical Devices, Clinical Development, Clinical Trials, Drug Development, Sop, CRO, 21 CFR Part 11, Higher Education, Veterinary Medicine, Anesthesiology, Critical Care, Surgery, Veterinary, Professional Writing, Training, Outcome Measures, Outcomes Research, Clinical Outcomes, Statistics, Public Speaking, Publications, Lecturing, Laboratory Skills, Medicine, Laboratory, Infectious Diseases, Vaccines, Lifesciences, Pain Management, Critical Care Medicine, FDA, Animal Models, Internal Medicine, Anesthesia, Oncology, Biotechnology, Pharmaceutical Sales, Regulatory Affairs, Microbiology, Healthcare, Commercialization, Epidemiology, Life Sciences, Clinical Research, Management, Product Launch, Leadership, Cross-functional Team...

Education
University of Minnesota-Twin Cities
Residency in Anesthesiology

Purdue University
Master of Science (MSc), Veterinary Surgery- Bioengineering

University of Illinois at Urbana-Champaign
DVM, Veterinary Medicine

University of Illinois at Urbana-Champaign
Bachelor of Science (BS), Microbiology, General

Tricia (Conway) Haydon Tricia (Conway) Haydon Greater Minneapolis-St. Paul Area Details
Tricia (Conway) Haydon's Myocor Experience 2003 - 2007
Job Marketing Consulting | Strategies & Execution | Clinical Trial Branding & Marketing | Healthcare | Med Device
Industry Medical Devices
Experience
Haydon & Partners, Inc.   2012 - Present
Nonin Medical, Inc.   2009 - 2012
Entellus Medical, Inc.   2007 - 2008
Myocor   2003 - 2007
Myocor   2000 - 2003
Boston Scientific  1995 - 2000
Becton Dickinson  1991 - 1995
US Healthcare, Inc.   1990 - 1991

Skills
Medical Devices, Market Development, Commercialization, Product Launch, Marketing, Interventional..., Product Marketing, Strategic Planning, Marketing Strategy, Capital Equipment, Cardiac Surgery, Remote Patient..., Brand Positioning..., Clinical Trial Branding, Clinical Trial Marketing, P&L Management, Relationship Building, Organizational Agility

Education
University of Rhode Island - College of Business Administration
Bachelor of Science (B.S.), Marketing, Concentration in Communication

Cheryl Hanson Cheryl Hanson Greater Minneapolis-St. Paul Area Details
Cheryl Hanson's Myocor Experience 1998 - 2005
Job Office Administrator at Tendyne Holdings, Inc.
Industry Medical Devices
Experience
Tendyne Holdings, Inc.   December 2012 - Present
Living Frontiers   January 2010 - Present
St. Jude Medical  February 2011 - December 2012
Celleration, Inc  2005 - 2009
Emerson Consultants   June 2005 - October 2005
Myocor   1998 - 2005
Leading Lady Companies   1993 - 1998
DBNS   1991 - 1993

Skills
Office Management, Web Design, Microsoft Office, HTML5, Illustrator, Facilities Management, Event Planning, Social Media, Medical Devices, Social Media Marketing, Wordpress, Management, Direct Sales, Marketing, Account Management, Leadership, HTML 5, Training, Cross-functional Team..., Start-ups, Sales, Strategy, Customer Service

Education
University of Minnesota-Twin Cities   1988 — 1992
Bachelor of Science, Human Ecology

Syracuse University
Chemical Engineering

Don Callander Don Callander Greater Minneapolis-St. Paul Area Details
Don Callander's Myocor Experience September 2006 - October 2008
Job Lay Pastor, Northwest Bible Church
Industry Religious Institutions
Experience
Northwest Bible Church  September 2013 - Present
Twin Cities Spoke of the International Christian Cycling Club   July 2012 - July 2014
Myocor   September 2006 - October 2008
CardiacAssist, Inc.   September 2005 - September 2006
Medi-Stim   April 2003 - September 2006
Medtronic Cardiac Surgery Technology   1998 - 2001
Avecor   1993 - 1998
U of MN  1992 - 1993
Cardiac Research Committee   1981 - 1985

Skills
Cardiology, Disposables, Surgeons, Clinical Trials, Capital Equipment, Cardiac Surgery, Medical Devices, Interventional..., Interventional Radiology, Operating Room, Vascular, Product Development, Healthcare, Clinical Research, Surgical Instruments, Neurosurgery, Market Development, Surgery, Hospitals, Product Management, Technical Support, Product Launch, Cath Lab, Spine, Vascular Surgery, Orthopedic, Neurology, FDA, Urology, Commercialization, Biomedical Engineering, ENT, Electrophysiology, Sales Effectiveness, Capital Equipment Sales, ISO 13485, Design Control, Global Marketing, Stents, Radiology, Ultrasound, Pacemakers, Catheters, Wound Care, Medical Sales, Heart Failure, Hardware Diagnostics, Regulatory Affairs, Operating Room Sales, Cardiothoracic Surgery

Education
North Hennepin Community College   1971 — 1975
Associate of Arts and Sciences (AAS), Perfusion Technology/Perfusionist

Dan Mans Dan Mans Greater Minneapolis-St. Paul Area Details
Dan Mans's Myocor Experience 2001 - 2005
Job Medical Device Executive
Industry Medical Devices
Experience
Voyageur Medical   January 2011 - Present
Osprey Medical  August 2011 - February 2013
American Medical Systems  December 2006 - November 2009
Spinelogy   2005 - 2006
Myocor   2001 - 2005
Sulzer Spine-Tech (now Zimmer Spine)   1998 - 2001
Medtronic  1993 - 1998

Skills
Medical Devices, FDA, Clinical Research, Product Development, Clinical Development, Design Control, Regulatory Affairs, Personal Communication, Orthopedic, Clinical Trials, Quality System, ISO 13485, Healthcare, Spine, V&V, Biomedical Engineering, Cardiology, Commercialization, Drug Delivery, Market Development, Urology, Leadership

Education
University of Minnesota-Twin Cities   1983 — 1987
BSME, Mechanical Engineering, Biomedical Engineering

HHS Class of '83

Ed Matthees Ed Matthees Greater Minneapolis-St. Paul Area Details
Ed Matthees's Myocor Experience January 1999 - January 2003
Job CEO at Matthees Medical
Industry Medical Devices
Experience
Matthees Medical   June 2009 - Present
LifeScience Alley  2009 - 2011
NeoMetrics, Inc.   2010 - 2010
Denali / Ivantis   June 2007 - August 2009
Denali Medical Inc.   November 2008 - June 2009
GraftCath Inc   January 2007 - June 2007
Myocor Inc   August 2006 - June 2007
St. Jude Medical (Cardiology Division)   September 2005 - August 2006
Anulex Technologies Inc   June 2003 - September 2005
Myocor   January 1999 - January 2003

Skills
Medical Devices

Education
University of Minnesota - Carlson School of Management   2000 — 2002
MS MOT

University of Minnesota-Twin Cities
BS Mechanical Engineering

Northwestern Electronics Institute
Diplomas, industrial and computer electronics

CJ Schweich CJ Schweich Greater Minneapolis-St. Paul Area Details
CJ Schweich's Myocor Experience 1997 - 2008
Job CEO at Caisson Interventional, LLC
Industry Medical Devices
Experience
Caisson Interventional, LLC   September 2012 - Present
Schweich-Mortier Partners, LLC   January 2009 - September 2012
Myocor   1997 - 2008
Boston Scientific / Scimed   1989 - 1996

Education
University of Minnesota Medical School   1985 — 1989
MD

University of Notre Dame   1981 — 1985
BS, Physics

Robert Atkinson Robert Atkinson Greater Minneapolis-St. Paul Area Details
Robert Atkinson's Myocor Experience 2003 - 2005
Job Entrepreneur, Executive and Patent Attorney
Industry Medical Devices
Experience
Prospex Medical   2005 - Present
ClarVista Medical, Inc.   2013 - Present
OcuTherix, Inc.   2014 - 2015
Apnex Medical, Inc.   2006 - 2011
BridgePoint Medical, Inc.   2005 - 2006
Myocor   2003 - 2005
Transoma Medical  2003 - 2005
Private Firm  1998 - 2003
Boston Scientific  1993 - 1998
SCIMED  1989 - 1993

Skills
Patents, Intellectual Property, Medical Devices, Start-ups, Regulatory Affairs, Clinical Trials, Entrepreneurship, Biotechnology, ISO 13485, Venture Capital, FDA, Research, Systems Engineering, R&D, Product Development, Biomedical Engineering, Product Launch, Commercialization, Engineering, Validation, Market Development, Cross-functional Team..., Quality System, Design Control, Strategic Planning, New Business Development

Education
William Mitchell College of Law   1993 — 1997
JD, Law

University of Minnesota-Twin Cities
BS, Mechanical Engineering

Brad Goskowicz Brad Goskowicz St. Cloud, Minnesota Area Details
Brad Goskowicz's Myocor Experience April 2006 - October 2008
Job Chief Executive Officer of Microbiologics
Industry Medical Devices
Experience
Microbiologics   January 2009 - Present
MOCON  2012 - Present
AOAC International  September 2013 - Present
Greater Saint Cloud Development Corporation   January 2013 - Present
American Association of Laboratory Accreditation   January 2014 - Present
US Speedskating  April 1992 - December 2012
US Speedskaitng   April 2006 - June 2011
Myocor   April 2006 - October 2008
Plexus  2004 - 2006
Abiomed  2003 - 2004

Skills
Cardiac Surgery, Interventional..., Microbiology, Cardiology, Clinical Research, International Sales, Sales Management, Marketing Strategy, Executive Management, Public Speaking, speedskating, Commercialization, Hospitals, Medical Devices, Leadership, Capital Equipment, Product Launch, Healthcare, Market Development, Clinical Development, Clinical Trials, Orthopedic, Product Development, Regulatory Affairs, Lifesciences, FDA, ISO 13485, Hardware Diagnostics, Biotechnology, Pharmaceutical Industry, Validation, R&D, Laboratory, Infectious Diseases, Quality System, GMP, Business Development, Marketing, Technology Transfer, Cross-functional Team..., Biopharmaceuticals, Sop, Management, Immunology, CAPA, Global Marketing, Quality Control, Biomedical Engineering, Vaccines, Life Sciences

Education
Marquette University   1974 — 1978
Bachelor of Science, Medical Technology, Chemistry

Jason Kalgreen Jason Kalgreen Greater Minneapolis-St. Paul Area Details
Jason Kalgreen's Myocor Experience June 2000 - March 2005
Job Program Manager
Industry Medical Devices
Experience
Medtronic  January 2014 - Present
ThreeWire  March 2011 - January 2014
Respicardia, Inc.   March 2009 - March 2011
Medtronic CRDM  March 2005 - March 2009
Myocor   June 2000 - March 2005
Boston Scientific/Target Therapeutics   June 1998 - June 2000
St. Jude Medical  June 1995 - June 1998

Skills
Medical Devices, Clinical Trials, Clinical Research, FDA, Regulatory Affairs, Cardiology, Healthcare, Product Launch, Pharmaceutical Industry, Clinical Development, R&D, Program Management, Cross-functional Team...

Education
Northwestern University   1990 — 1994
BS, Biomedical Engineering

University of Minnesota-Twin Cities   1995 — 2000
MS, Biomedical Engineering

Dan Langanki Dan Langanki Greater Minneapolis-St. Paul Area Details
Dan Langanki's Myocor Experience May 2000 - October 2003
Job Independent Preclinical / Clinical Consultant at Dan Langanki LLC
Industry Medical Devices
Experience
Dan Langanki LLC   June 2012 - Present
Medrad / Bayer Interventional   May 2009 - 2012
Surpass   February 2008 - May 2009
Boston Scientific  October 2003 - January 2008
Myocor   May 2000 - October 2003
St. Jude Medical  August 1995 - May 2000

Skills
Medical Devices, Regulatory Submissions, CRO, Cardiology, Quality System, Clinical Research, Clinical Development, GLP, CAPA, ISO 13485, Clinical Study Design, Clinical Trials, Sop, Lifesciences, GCP, Interventional..., Protocol, Regulatory Affairs, Validation, CTMS, Biomedical Engineering, Vascular, GMP, Clinical Monitoring, R&D

Education
University of Minnesota-Twin Cities   1987 — 1991
BS, Biochemistry

Harold Torunsky Harold Torunsky Greater Minneapolis-St. Paul Area Details
Harold Torunsky's Myocor Experience Manager, Clinical StudiesTelectronics Pacing Systems1991 - 1997
Job Director, Clinical Research at Myocor
Industry Medical Devices
Experience
Myocor   Manager, Clinical StudiesTelectronics Pacing Systems1991 - 1997

Education
Marquette University   1980 — 1984

Craig Ekvall Craig Ekvall Greater Minneapolis-St. Paul Area Details
Craig Ekvall's Myocor Experience February 1999 - June 2008
Job R&D Engineer at Tendyne Holdings, Inc.
Industry Medical Devices
Experience
Tendyne Holdings, Inc.   October 2012 - Present
Torax Medical  July 2008 - October 2012
Myocor   February 1999 - June 2008
Boston Scientific  September 1995 - February 1999

Education
Anoka Ramsey Community College   1991 — 1993

Mike Winegar Mike Winegar Greater Minneapolis-St. Paul Area Details
Mike Winegar's Myocor Experience 2000 - 2001
Job Principal at Winegar Consulting
Industry Medical Devices
Experience
Winegar Consulting   January 2013 - Present
Medpace Medical Device  2011 - January 2013
Kips Bay Medical   2007 - 2011
Enpath   2006 - 2007
ev3  2001 - 2005
Myocor   2000 - 2001
Boston Scientific Scimed  1989 - 2000
Medtronic  1986 - 1989
Medical, Inc.   1982 - 1986

Education
University of Minnesota-Twin Cities   1980 — 1982
Bachelor of Science, Microbiology

Kyle Luehman Kyle Luehman Greater Minneapolis-St. Paul Area Details
Kyle Luehman's Myocor Experience February 2007 - June 2008
Job Operations Project Engineer at Caisson Interventional
Industry Medical Devices
Experience
Caisson Interventional   July 2014 - Present
Zyga Technology   June 2013 - July 2014
Vascular Solutions  April 2012 - June 2013
Atritech, a subsidiary of Boston Scientific Corporation   March 2011 - April 2012
Atritech  June 2008 - March 2011
Myocor   February 2007 - June 2008
St. Jude Medical  2005 - 2007
Velocimed, LLC.   2005 - 2006
Boston Scientific  January 2002 - January 2005
Boston Scientific  January 2000 - January 2002

Skills
Medical Devices, Design Control, Design of Experiments, FDA, ISO 13485, Capital Equipment, FMEA, Lean Manufacturing, Validation, Manufacturing..., V&V, Manufacturing, Process Simulation, CAPA, Commercialization

Education
University of Minnesota-Duluth   1993 — 1998
BS, Manufacturing/Industrial Engineering, Minor Mathematics

Char Knutson Char Knutson Greater Minneapolis-St. Paul Area Details
Char Knutson's Myocor Experience November 2007 - October 2008
Job Retired
Industry Medical Devices
Experience
Retired and enjoying Life.  June 2015 - Present
Medpace Medical Devices   November 2008 - June 2015
Medtronic  2008 - 2014
Medtronic  2008 - 2014
Boston Scientific  February 1991 - November 2008
Myocor   November 2007 - October 2008
GV Medical Inc   1985 - 1991

Education
Anoka Ramsey Community College   1970 — 2000

Matt Weston Matt Weston Greater Minneapolis-St. Paul Area Details
Matt Weston's Myocor Experience 2004 - 2008
Job Principal R&D Engineer at Medtronic
Industry Medical Devices
Experience
Medtronic  August 2010 - Present
ATS Medical, Inc.   2008 - August 2010
Myocor   2004 - 2008
St. Jude Medical  2000 - 2004

Skills
Medical Devices, Cross-functional Team..., V&V, Testing, Design of Experiments, Design Control, Biomedical Engineering, Vascular, Quality System, R&D, Validation

Education
Georgia Institute of Technology   1994 — 2000
PhD, Chemical Engineering

Penn State University   1989 — 1994
BS/MS, Chemical Engineering

Chris Brodeur Chris Brodeur Greater Minneapolis-St. Paul Area Details
Chris Brodeur's Myocor Experience June 2006 - June 2008
Job Principal R&D Engineer at HLT, Inc.
Industry Medical Devices
Experience
HLT, Inc.   April 2012 - Present
American Medical Systems  August 2011 - April 2012
Teleflex Medical  May 2010 - August 2011
ev3 Inc.  June 2008 - June 2010
Myocor   June 2006 - June 2008
Boston Scientific  1997 - 2006
SurModics  September 1995 - April 1997
Watson Pharmaceutical Laboratories   November 1994 - September 1995

Skills
Design of Experiments, Six Sigma, Machinery, Medical Devices, ISO 13485, Design Control, FDA, V&V, CAPA, R&D, Minitab, Validation, FMEA

Education
University of California, Riverside
B.S., Physics

Brian O'Connell Brian O'Connell Greater Minneapolis-St. Paul Area Details
Brian O'Connell's Myocor Experience October 2002 - August 2005
Job Owner, Key Surgical, Inc.
Industry Medical Devices
Experience
Key Surgical, Inc.   August 2005 - Present
Myocor   October 2002 - August 2005
Guidant  March 2000 - October 2002
Guidant  August 1999 - March 2000
Guidant  1998 - 1999
Guidant  1996 - 1998
Guidant  1995 - 1996
Guidant  1993 - 1995
Cardiac Pacemakers, Inc.   1991 - 1993
Molex  1987 - 1989

Skills
Product Development, Sales, New Business Development, Marketing, Medical Devices, Regulatory Affairs, Clinical Trials, Healthcare, Process Improvement, Cross-functional Team..., Market Development, Hospitals, Product Launch, Commercialization, FDA, ISO 13485, Design Control, Biomedical Engineering, Capital Equipment, R&D, Start-ups, Cardiology

Education
University of Pennsylvania - The Wharton School   1989 — 1991
MBA, Marketing

Lehigh University   1981 — 1985
BSEE, Electrical Engineering

Summit High School   1977 — 1981
HS Diploma

Todd Mortier Todd Mortier Greater Minneapolis-St. Paul Area Details
Todd Mortier's Myocor Experience September 1996 - October 2008
Job Founder and COO at Caisson Interventional
Industry Medical Devices
Experience
Caisson Interventional   September 2012 - Present
Schweich-Mortier Partners   October 2008 - Present
Myocor   September 1996 - October 2008
Boston Scientific  1990 - 1996

Education
University of Minnesota-Twin Cities

Erik Kari Erik Kari Greater Minneapolis-St. Paul Area Details
Erik Kari's Myocor Experience January 2005 - November 2008
Job Sr. Director of Quality at Tendyne Holdings, Inc.
Industry Medical Devices
Experience
Tendyne Holdings, Inc.   February 2015 - Present
Tendyne Holdings, Inc.   April 2012 - February 2015
KSpine, Inc.   August 2009 - April 2012
TUV America  November 2008 - August 2009
Myocor   January 2005 - November 2008
Myocor   October 1999 - January 2005
St. Jude Medical  February 1998 - October 1999
St. Jude Medical  January 1997 - February 1998
St. Jude Medical  June 1995 - January 1997
St. Jude Medical  April 1994 - June 1995

Skills
Quality System, ISO 13485, Validation, Medical Devices, Quality Management, Manufacturing, R&D, Quality Assurance, Continuous Improvement, ISO, Quality Auditing, Engineering, FDA, Design Control, Sop, CAPA, V&V, Program Management, FMEA

Education
Saint Mary's University of Minnesota   1999 — 2001
BS Industrial Technology, Medical Devices

NEI College of Technology   1988 — 1990
A.A.S. Electronics Technology

Penny Petersen Penny Petersen Greater Minneapolis-St. Paul Area Details
Penny Petersen's Myocor Experience December 2006 - Present
Job Clinical Evaluation Associate at Myocor
Industry Medical Devices
Experience
Myocor   December 2006 - Present
CHF Solutions  February 2005 - December 2006

Education
Anoka Ramsey Community College

Jill Tufano Jill Tufano Minneapolis, Minnesota Details
Jill Tufano's Myocor Experience November 1999 - February 2001
Job Director of Client Services
Industry Medical Devices
Experience
Fortress Medical Systems, LLC.   April 2013 - Present
The Paint Pub   March 2012 - Present
Medpace  September 2011 - March 2013
NaviGo Research   December 2008 - December 2011
Abbott Vascular  March 2010 - October 2011
The Integra Group  August 2002 - December 2008
Tufano and Associates   February 2001 - August 2002
Myocor   November 1999 - February 2001
Urologix  1996 - 1999

Skills
Clinical Trials, Clinical Research, Biotechnology, Cardiology, Lifesciences, CTMS, EDC, Data Management, Sop, Pharmaceutical Industry, Protocol, Clinical Data Management, Regulatory Affairs, Quality System

Education
Purdue University   1990 — 1994
BS, Biological Sciences

Purdue University   1990 — 1994
BS, Biology

Scott Northrup Scott Northrup Greater Minneapolis-St. Paul Area Details
Scott Northrup's Myocor Experience 2007 - 2008
Job
Industry Information Technology and Services
Experience
Covidien/ev3  March 2011 - October 2013
Johnson & Johnson - Codman Neurovascular   August 2009 - March 2011
Myocor   2007 - 2008
Edwards Lifesciences  2001 - 2007
CryoLife, Inc.   May 1995 - May 1997
The Bergquist Company  November 1994 - April 1995

Skills
Medical Devices, Market Development, Interventional Radiology, Neurovascular, Cardiac Surgery, Cardiology, Disposables, Capital Equipment, Operating Room, Surgeons, Product Launch, Cath Lab, Vascular, Interventional..., Neurosurgery, Surgery, Urology, Surgical Instruments, Spine

Education
University of Minnesota-Twin Cities   1988 — 1994
BS, Genetics and Cell Biology

Jill Munsinger Jill Munsinger Greater Minneapolis-St. Paul Area Details
Jill Munsinger's Myocor Experience May 2006 - October 2008
Job Regulatory Affairs Consultant
Industry Medical Devices
Experience
JM Consulting Services, LLC   October 2008 - Present
Myocor   May 2006 - October 2008
ev3 Inc  2002 - 2006
Regulatory & Clinical Research Institute   August 2001 - December 2002
Novoste   1999 - 2001

Skills
Medical Devices, FDA, Clinical Development, ISO 13485, Clinical Trials, Sop, R&D, Design Control, Manufacturing, Regulatory Affairs, Validation, Biomedical Engineering, Biotechnology, Quality System, Cardiology, Clinical Research, Product Development, V&V, GMP, Cross-functional Team..., Lifesciences, CAPA

Education
University of Minnesota-Twin Cities   1991 — 1996
Genetics & Cell Biology

Gordon J Andersen (GJ) Gordon J Andersen (GJ) Greater Minneapolis-St. Paul Area Details
Gordon J Andersen (GJ)'s Myocor Experience November 1999 - October 2008
Job Associate Quality Engineer at Tendyne Holdings, Inc.
Industry Medical Devices
Experience
Tendyne Holdings, Inc.   February 2015 - Present
Rotation Medical  May 2011 - Present
Gyrus ACMI  February 2010 - May 2011
Medtronic  2009 - February 2010
Ivantis   November 2008 - January 2009
Myocor   November 1999 - October 2008
Boston Scientific  1990 - 1995

Skills
Medical Devices, FDA, ISO 13485, V&V, CAPA, Quality System, Design Control, Validation, FMEA, GMP, 21 CFR Part 11, Quality Auditing, Design of Experiments, Root Cause Analysis, Manufacturing, Quality Assurance, Product Development, Testing, Supplier Quality

Education
Anoka Ramsey Community College
AS, Applied Engineering

Harold Torunsky Harold Torunsky Greater Minneapolis-St. Paul Area Details
Harold Torunsky's Myocor Experience 2005 - 2008
Job Work in Clinical Research Field
Industry Medical Devices
Experience
Independent Contractor  2011 - Present
Medtronic  2008 - 2011
Myocor   2005 - 2008
Guidant, Corp.   2003 - 2005
St. Jude Medical  1997 - 2003
Telectronics (Acquired by St. Jude Medical in 1997)   1991 - 1997

Skills
Clinical Trials, CTMS, Medical Devices, Design Control, FDA, Clinical Research, Cardiology, Regulatory Affairs, CAPA, Validation, ISO 13485, Clinical Development, Clinical Operations, GCP, Biomedical Engineering, Regulatory Submissions, Protocol, 21 CFR Part 11, V&V, Biotechnology, Quality System, EDC, R&D, Sop, Clinical Data Management, CRO, Hardware Diagnostics, Lifesciences, Regulatory Requirements, GLP, Medical Writing, Life Sciences, SOP

Education
University of Colorado Denver   1992 — 1997
M.S. in Information Systems

University of Colorado Denver   1992 — 1997
Master of Business Administration (MBA)

Marquette University   1980 — 1984
Bachelor of Engineering (BEng), Bio-Medical