MiCardia Corporation
Industry: Company
DescriptionFounded: 2004
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MiCardia Corporation Employees
Tenex Health July 2014 - Present
Sechrist Industries April 2013 - July 2014
MiCardia Corporation April 2012 - April 2013
Beckman Coulter January 2009 - November 2011
Beckman Coulter January 2001 - January 2009
Disneyland Resort October 1999 - January 2001
Smartflex Systems July 1997 - September 1999
Marshall Industries April 1996 - July 1997
Skills
Quality System..., Document Control, Supply Management, Strategic Sourcing, Procurement, Continuous Improvement, CAPA, Project Management, MRP, Medical Devices, Training, Supplier Quality, Cross-functional Team..., ISO 13485, Regulatory Submissions, Manufacturing, Quality Control, Medical Device Directive, Complaint Investigations, FDA, Quality System, Process Improvement
Education
California State University-Fullerton - College of Business and Economics
Bachelor of Arts, Business Administration
National Education Center, Anaheim
Associate of Specialized Technology, Electronics Engineering
Warren High School, Downey, CA
Revision Optics March 2012 - Present
MicroVention March 2011 - March 2012
micardia corporation February 2008 - February 2011
Sonix Therapeutics 2009 - 2010
Restech 2003 - 2007
Endonetics 1999 - 2002
Navius 1996 - 1998
Medtronic miv 1993 - 1996
Edwards Lifesciences January 1985 - December 1992
Rockwell 1983 - 1985
Skills
Medical Devices, ISO 13485, Design Control, SPC, R&D, FDA, CAPA, Stents, Product Launch, Product Development, Biomedical Engineering, ISO, Quality System, Surgical Instruments, ISO 14971, V&V, Biotechnology, Capital Equipment, Manufacturing, GMP, Root Cause Analysis, CE marking, Design of Experiments, Market Development, Validation, Engineering, FMEA, Catheters, Commercialization, Injection Molding, Cross-functional Team..., Lean Manufacturing, Solidworks, Polymers, SolidWorks
Education
California State University-Long Beach
Endologix Inc March 2013 - Present
MiCardia Corporation December 2005 - Present
Trimedyne Inc October 2003 - December 2005
Volcano Therapeutics, Inc. December 2002 - November 2003
MicroVention April 2001 - December 2002
Skills
Medical Devices, Solidworks, R&D, Biomedical Engineering, Manufacturing Management, Prototyping, ISO 13485, ISO 14971, Manufacturing..., FDA, V&V, Quality System, FMEA, Design Control, Continuous Improvement, Machining, Quality Control, Design of Experiments, ISO, CAPA, Manufacturing, Design for Manufacturing, Catheters, Minitab, Unigraphics, Injection Molding, SPC, CE marking, Matlab, Supplier Quality, Manufacturing..., Root Cause Analysis, Product Design, DMAIC, Lean Manufacturing, GD&T, GMP, Six Sigma, Medical Device R&D, Product Development, Pro Engineer
Education
California State University-Long Beach
Bachelor's degree, Mechanical Engineer
Orange Coast College 2002 — 2004
CNC, Machine Shop
Endologix Inc March 2011 - Present
MiCardia Corporation June 2008 - March 2011
Arbor Surgical Technologies June 2007 - September 2007
National Taiwan Ocean University July 2006 - August 2006
Skills
Medical Devices, Solidworks, R&D, Manufacturing, Validation, Quality System, GMP, Quality Assurance, Testing, Engineering, Biomedical Engineering, Design Control, FDA, Product Development, V&V, CAPA, CAD, Design of Experiments, SolidWorks
Education
University of California, Irvine 2004 — 2008
B.S., Biomedical Engineering
University of California, Irvine - The Paul Merage School of Business 2004 — 2008
Minor, Management
MiCardia Corporation July 2006 - June 2007
Education
University of California, San Diego 1994 — 1999
Edwards Lifesciences September 2014 - Present
Edwards Lifesciences December 2010 - September 2014
Cameron Health August 2009 - December 2010
MiCardia Corporation September 2008 - July 2009
Edwards Lifesciences May 2006 - September 2008
Thomas & Betts June 2004 - April 2006
Mapal Inc. 2001 - 2004
Skills
Pro Engineer, Six Sigma, Solidworks, Quality System, Product Development, Design of Experiments, Lean Manufacturing, ISO 13485, Medical Devices, Injection Molding, R&D, Design Control, Manufacturing, Quality Management, FMEA, Design for Manufacturing, CAPA, ISO 14971, V&V, FDA, Validation, Minitab, Biomedical Engineering, Machine Tools
Education
New Jersey Institute of Technology 2000 — 2002
MS, Engineering Management
American University of Beirut 1995 — 1999
BS, Mechanical Engineering
MicroVention July 2011 - Present
Hansen Medical 2010 - July 2011
MiCardia Corporation October 2008 - August 2009
Interface Associates, Inc. January 2008 - October 2008
Edwards Lifesciences March 2001 - January 2008
Johnson & Johnson 1991 - 1998
Skills
Medical Devices, Design Control, ISO 13485, FDA, Biomedical Engineering, D.O.E., Decision Analysis/Fast..., Emotional Intelligence..., Coaching Team for Core..., R&D, Catheters, V&V, Validation, CAPA, Manufacturing..., Process Simulation, Quality System, Design of Experiments, Manufacturing
Education
North Carolina State University 1982 — 1985
BS, Mechanical Engineering
Direct Flow Medical®, Inc. June 2015 - Present
Zarbatany Consulting, LLC June 2009 - Present
Acutus Medical, Inc. January 2014 - May 2015
MiCardia Corporation October 2005 - July 2008
Edwards Lifesciences 2001 - 2006
Biosensors International 2000 - 2001
Boston Scientific 1997 - 2000
Medtronic 1992 - 1997
USCI 1988 - 1990
Education
Drexel University 1981 — 1986
BS, Mechanical Engineering
University of Rhode Island - College of Business Administration
MBA
MiCardia Corporation / ValCare Medical March 2010 - Present
MiCardia Corporation 2010 - 2012
Arbor Surgical Technologies, Inc August 2009 - January 2010
Solace Therapeutics October 2001 - June 2009
Solace Therapeutics October 2001 - June 2009
Radiance Medical Systems Incorporated January 1999 - October 2001
CardioVascular Dynamics Incorporated January 1997 - January 1999
Trimedyne Incorporated January 1992 - January 1997
Trimedyne Incorporated September 1990 - January 1992
Animal December 1989 - January 1990
Skills
Medical Devices, Engineering, Product Development, Catheters, Testing, Manufacturing, ISO 13485, Design Control, R&D, V&V, CAPA, Injection Molding, AutoCAD, Mechanical Engineering, Solidworks, Validation
Education
Santiago Canyon College 2006 — 2008
Mechanical Engineering
Graduate PolyTechnics High School
Mechanical Engineering Field
MiCardia Corporation August 2013 - Present
MiCardia Corporation August 2013 - Present
ValCare Medical, Inc. June 2012 - July 2013
MiCardia Corporation October 2011 - June 2013
IntriMed January 2011 - December 2011
ATS Medical, Inc. October 2009 - August 2010
MiCardia Corporation January 2007 - September 2009
3F Therapeutics, Inc. October 2001 - October 2006
Skills
Medical Devices, Biomedical Engineering, FDA, Professional Engineer -..., ASQ Certified Six Sigma..., ISO 13485, Design Control, Product Launch, R&D, Orthopedic, Healthcare, Surgery, Market Development, Capital Equipment, ASQ Quality Auditor, Surgeons, Surgical Instruments, Design of Experiments, Operating Room, Lifesciences, Disposables, Quality System, Cardiology, Biotechnology, Interventional..., Vascular, Commercialization
Education
University of California, Irvine - The Paul Merage School of Business 1990 — 1992
Master of Business Administration (M.B.A.), Business Administration and Management, General
University of Iowa 1976 — 1980
Bachelor of Engineering, Biomedical, Biomedical/Medical Engineering
Oraya Therapeutics, Inc. January 2013 - Present
MiCardia Corporation 2012 - Present
Medtronic September 1975 - Present
Skills
Medical Device..., Controlled Environments, Materials Of Animal..., Sterilization, Microbiology
Education
Cal Poly Pomona 1977 — 1981
Bachelor's degree, Medical Microbiology and Bacteriology