Vibrynt Company
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Vibrynt Employees
Medical Device Consultants Group February 2015 - Present
RAPS SF CHAPTER November 2012 - Present
Glooko March 2013 - February 2015
Glooko,inc April 2011 - March 2013
UCSC Extension January 2010 - June 2012
powervision 2011 - 2011
Abbott Nutrition June 2004 - March 2010
Vibrynt 2010 - 2010
Skills
FDA, Quality System, Clinical Research, Regulatory Submissions, Regulatory Affairs, Healthcare, Medical Devices, Quality Assurance, ISO 13485, R&D, CAPA, Product Development, V&V, Biotechnology, Quality Auditing, Regulatory Requirements
Education
The Ohio State University
Masters, Nutrition (Molecular nutrition), biology
University of California, Santa Cruz
Intuitive Surgical November 2011 - February 2014
DFine, Inc. April 2010 - December 2010
VIbrynt Inc April 2009 - August 2009
SurgRx, Ethicon Endo-Surgery, Inc. May 2006 - April 2009
Vibrynt 2009 - 2009
Ethicon Endo-Surgery (SurgRx) 2006 - 2009
LifeScan, Johnson & Johnson July 2005 - May 2006
Circle Medical Devices October 2004 - February 2005
J&J, NDC 2005 - 2005
V. Mueller Neuro/Spine Products (Cardinal Health) January 2000 - August 2004
Skills
Product Design, Medical Devices, Design for Manufacturing, Design Control, V&V, Mechanism Design, FDA, ISO 13485, FMEA, Design of Experiments, Machine Tools, Product Development, Solidworks, Engineering, Manufacturing, Quality Assurance, Validation, ISO, Injection Molding, Package Testing, ASTM D4169, Testing, Mechanical Engineering, Surgical Instruments, R&D, Manufacturing..., Product Launch, CAPA, Pro Engineer, Quality System
Education
DeVry University-California
Bachelor of Science (BSc) Technology
San Jose Surgical Group October 2014 - Present
Ocular Dynamics, LLC January 2011 - Present
UC San Francisco-Fresno 2010 - December 2013
Acute Care Surgery Medical Group 2011 - 2013
Vibrynt 2011 - 2012
Skills
General Surgery, Critical Care, Medical Technology, Medical Devices, Biomedical Engineering, Trauma Surgery, Lifesciences, Clinical Research, Biotechnology, Surgery, Clinical Trials, Cancer, Medicine, Medical Education, Healthcare, Biomaterials, FDA, Ophthalmology, Healthcare Information..., Innovation, Product Innovation, Innovation Consulting, Vascular Surgery, Intellectual Property, Guest Lecturing, Bioengineering, Clinical Development, Hardware Diagnostics, Medical Imaging, R, Physicians, Board Certified, Entrepreneurship, Patents, Biochemistry, Innovation Management, Informatics, R&D
Education
Stanford University 2010 — 2011
Post Doctorate, Biodesign (Medical Device Entrepreneurship)
University of California, San Francisco-Fresno 2005 — 2010
General Surgery Residency Program
University of Illinois at Urbana-Champaign 2001 — 2005
Doctor, Medicine
Xavier University of Louisiana 1997 — 2001
Bachelor of Science, Chemistry
Welkin Health May 2015 - Present
Embrace Innovations February 2013 - Present
Gwiz Consulting September 2010 - Present
Hint Health December 2014 - March 2015
Tradecraft November 2014 - February 2015
NeoTract October 2012 - December 2014
Sensible Health November 2013 - October 2014
Better Ventures March 2013 - June 2013
Vibrynt May 2010 - December 2012
Cardica November 2006 - October 2007
Skills
Product Development, Product Design, Business Development, Sales, User-centered Design, Design Thinking, Lean Thinking, Manufacturing, Medical Devices, New Business Development, Sales Operations, Strategic Customer..., Product Innovation, Leadership, Social Entrepreneurship, Creative Problem Solving, Teaching, Mentoring, Consulting, R&D, Solidworks, CAD, Machining, Design for Manufacturing, Injection Molding, Rapid Prototyping, FDA, V&V, Testing, Design Control, Kaizen, Adventure Travel, Travel Writing
Education
Stanford University 1997 — 2003
BS, MS
Sandia High School 1993 — 1997
Diploma
Nuelle, Inc January 2015 - Present
Acclarent May 2013 - January 2015
Vibrynt February 2011 - March 2013
Vibrynt May 2008 - February 2011
Boston Scientific- Guidant Cardiac Surgery June 2006 - October 2007
Guidant Cardiac Surgery July 2003 - June 2006
Guidant- Endovascular Solutions September 1997 - June 2003
Skills
Design Control, R&D, FDA, Medical Devices, Cross-functional Team..., ISO 13485, Project Management, Biomaterials, Validation, Product Development, V&V, Quality System, Product Launch, Testing, Biomedical Engineering, Commercialization, Continuous Improvement, CAPA, Design of Experiments, ISO 14971, Design for Manufacturing
Education
University of Pennsylvania 1996 — 1997
MSE
Philadelphia University 1992 — 1996
BS
Stanford University September 2012 - Present
Stanford University August 2010 - September 2012
Vibrynt June 2009 - August 2010
Vibrynt July 2007 - June 2009
Stanford University September 2005 - June 2007
Barosense June 2006 - September 2006
Apple June 2005 - September 2005
Skills
Rapid Prototyping, Product Design, Curriculum Design, Testing, Mechanical Engineering, User-centered Design, Industrial Design, Prototype, Quilting, Design for Manufacturing, Entrepreneurship, Machining, Solidworks, CAD, Product Innovation, Concept Development, Cnc, Lathe, Product Development, Injection Molding, Medical Devices, 3D Printing, Engineering, Laser Cutting, Milling, Sketching, Metal Fabrication, CAD/CAM, Concept Design, R, Creative Problem Solving, Design Education, R&D, Woodworking, SolidWorks
Education
Stanford University 2005 — 2007
MS, Mechanical Engineering
Stanford University 2001 — 2005
BS, Product Design
Intuitive Surgical March 2013 - Present
The Medical Device Industry October 2012 - February 2013
Vibrynt February 2008 - September 2012
Abbott Vascular Devices 2005 - 2008
Guidant January 2002 - September 2004
Guidant June 1998 - January 2002
Guidant February 1996 - June 1998
Advanced Cardiovascular Systems, Inc. 1990 - 1998
Skills
Design Control, Medical Devices, Mechanical Engineering, Solidworks, Program Management, Project Management, Management, CAPA, R&D, Fixture Design, Testing, Report Writing, Invention, Patents, Supervising, Career Development, Mechanical Testing, Product Design, Injection Molding, Stents, FDA, ISO 13485, V&V, Biomedical Engineering, Cross-functional Team..., Product Development, Manufacturing, Biotechnology, Validation, Quality System, Commercialization, Design of Experiments, GLP, ISO 14971, Biomaterials, Product Launch, Lifesciences, GMP, FMEA, Design for Manufacturing, SolidWorks, Life Sciences
Education
San Jose State University 1982 — 1986
Bachelor's degree, Physics
Loyola Marymount University
Short course in Biomedical Instrumentation, Engineering
Independent Consultant September 2015 - Present
Progyny, Inc. April 2014 - September 2015
Independent Consultant April 2013 - April 2014
Vibrynt June 2011 - March 2013
Boston Scientific (formerly Guidant) May 2006 - May 2011
Guidant 1998 - April 2006
Medtronic 1995 - 1998
Cardiometrics April 1995 - December 1995
Pacific Biotech April 1994 - April 1995
Pacific Biotech April 1993 - March 1994
Skills
Medical Devices, PMA, Regulatory Submissions, CE marking, ISO 13485, Clinical Trials, Compliance, Design Control, FDA, International..., IDE, 510(k), Quality System, CAPA, V&V, Regulatory Affairs, 21 CFR Part 11, Clinical Research, Regulatory Requirements, ISO 14971, GCP, Hardware Diagnostics, Change Control, Biomedical Engineering, Clinical Development, Biotechnology, Sop, R&D, CTMS
Education
University of Minnesota-Twin Cities 1990 — 1992
BS, Biology
Minnesota State University, Moorhead 1987 — 1990
Biology
Ceterix Orthopaedics June 2013 - Present
PulmonX April 2010 - June 2013
Voyage Medical February 2010 - April 2010
Vibrynt September 2009 - February 2010
Emphasys Medical January 2008 - February 2009
Systron Donner Inertial July 2004 - January 2008
Skills
Design Control, CAPA, Design of Experiments, Manufacturing, ISO 13485, V&V, FDA, Quality System, ISO 14971, Medical Devices, Design for Manufacturing, Validation, Biomedical Engineering, Catheters, FMEA, R&D, Solidworks, CE marking, Injection Molding, Manufacturing..., SPC
Education
California Polytechnic State University-San Luis Obispo 1998 — 2003
BS, Industrial Engineering