Evalve, Inc.
Industry: Company
DescriptionHeadquarters: Menlo Park, CA Founded: 1999 Parent organization: Abbott Laboratories People also search for: Abbott Vascular, FeedbackDisclaimer Claim this knowledge panel Knowledge Result Moved, closed, or was never hereReportEvalve IncDirections Saved (0) Saved Save Law firm in Menlo Park, California Address: 4045 Campbell Ave, Menlo Park, CA 94025Hours: Category: : : : Place name: : : : Website: Phone: Category: Law firm Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo. · Own this business?Add missing informationAdd phone number Unable to add this file. Please check that it is a valid photo. Add business hours Unable to add this file. Please check that it is a valid photo. Add website Unable to add this file. Please check that it is a valid photo. Questions & answers Ask a questionBe the first to ask a question Add a photoThanks for sharing!Your photo will be posted publicly on Google.Contribute MoreDoneUpload public photos of Evalve Inc Posting publicly on the Web Write a review Reviews Be the first to review
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Evalve, Inc. Employees
Employee
Years
Job
Industry
Shawn Davis Shawn Davis's Evalve, Inc. Experience September 2009 - April 2011
Job Quality Manager at Elixir Medical
Industry Medical Devices
Experience
Elixir Medical October 2014 - Present
Abbott Vascular September 2009 - October 2014
Evalve, Inc. September 2009 - April 2011
Curexo Technology Corporation July 2008 - February 2009
Health Net December 2007 - July 2008
GE Healthcare November 2004 - December 2007
GE Healthcare June 2001 - November 2004
Skills
Six Sigma, Cross-functional Team..., Project Management, Quality System, Validation, CAPA, Testing, Leadership, FMEA, Team-oriented, FDA, ISO 13485, Continuous Improvement, Lean Manufacturing, Root Cause Analysis, Design Control, Organized Multi-tasker, Positive Personality, Medical Devices, Process Improvement, Product Development, Success Oriented, Integration, Software Development, Manufacturing, V&V, Engineering, Quality Control, Program Management, Quality Assurance, Customer Service, DMAIC, ISO 14971, Quality Auditing, Team Building, Strategic Leadership, Supplier Quality
Education
Milwaukee School of Engineering 1997 — 2001
Bachelor of Science, Computer Engineering
Elixir Medical October 2014 - Present
Abbott Vascular September 2009 - October 2014
Evalve, Inc. September 2009 - April 2011
Curexo Technology Corporation July 2008 - February 2009
Health Net December 2007 - July 2008
GE Healthcare November 2004 - December 2007
GE Healthcare June 2001 - November 2004
Skills
Six Sigma, Cross-functional Team..., Project Management, Quality System, Validation, CAPA, Testing, Leadership, FMEA, Team-oriented, FDA, ISO 13485, Continuous Improvement, Lean Manufacturing, Root Cause Analysis, Design Control, Organized Multi-tasker, Positive Personality, Medical Devices, Process Improvement, Product Development, Success Oriented, Integration, Software Development, Manufacturing, V&V, Engineering, Quality Control, Program Management, Quality Assurance, Customer Service, DMAIC, ISO 14971, Quality Auditing, Team Building, Strategic Leadership, Supplier Quality
Education
Milwaukee School of Engineering 1997 — 2001
Bachelor of Science, Computer Engineering
Jeanette Burkhardt-Mancini Jeanette Burkhardt-Mancini's Evalve, Inc. Experience July 2009 - June 2010
Job Sr. Clinical Research Associate at Guided Delivery Systems, Inc.
Industry Medical Devices
Experience
Guided Delivery Systems, Inc. January 2015 - Present
Abbott Vascular Structural Heart (formerly Evalve, Inc.) August 2012 - January 2015
Abbott Vascular Structural Heart (formerly Evalve, Inc.) February 2011 - July 2012
Abbott Vascular Structural Heart (formerly Evalve, Inc.) July 2010 - January 2011
Evalve, Inc. July 2009 - June 2010
Skills
Clinical Trials, Clinical Research, Medical Devices, EDC, FDA, GCP, CTMS, Clinical Development, Clinical Data Management, Validation, Biotechnology, GMP, ICH-GCP, Vascular, Cardiology, CAPA, Clinical Monitoring, Lifesciences, ISO 13485, Biomedical Engineering, Design Control, PMA, Clinical Research..., Interventional..., Protocol, 21 CFR Part 11, Regulatory Submissions, Regulatory Affairs, Quality Assurance, Pharmaceutical Industry, CRO, Safety Narrative Writing
Education
Santa Clara University
Marriage Family Child Counseling
The Ohio State University
Bachelor of Science (B.S.), Medical Illustration
Guided Delivery Systems, Inc. January 2015 - Present
Abbott Vascular Structural Heart (formerly Evalve, Inc.) August 2012 - January 2015
Abbott Vascular Structural Heart (formerly Evalve, Inc.) February 2011 - July 2012
Abbott Vascular Structural Heart (formerly Evalve, Inc.) July 2010 - January 2011
Evalve, Inc. July 2009 - June 2010
Skills
Clinical Trials, Clinical Research, Medical Devices, EDC, FDA, GCP, CTMS, Clinical Development, Clinical Data Management, Validation, Biotechnology, GMP, ICH-GCP, Vascular, Cardiology, CAPA, Clinical Monitoring, Lifesciences, ISO 13485, Biomedical Engineering, Design Control, PMA, Clinical Research..., Interventional..., Protocol, 21 CFR Part 11, Regulatory Submissions, Regulatory Affairs, Quality Assurance, Pharmaceutical Industry, CRO, Safety Narrative Writing
Education
Santa Clara University
Marriage Family Child Counseling
The Ohio State University
Bachelor of Science (B.S.), Medical Illustration
Bub Edwards Bub Edwards's Evalve, Inc. Experience August 2004 - November 2009
Job Experienced Regional Manager and Sales Professional
Industry Medical Devices
Experience
Invuity Inc August 2010 - August 2011
Evalve, Inc. August 2004 - November 2009
Baxter Healthcare/ Fusion Medical November 1999 - August 2004
Sulzer Vascutek April 1999 - November 1999
Cardima July 1997 - April 1999
Advanced Cardiovascular Systems/ Guidant September 1994 - July 1997
Intervascular,Inc January 1987 - September 1994
Skills
Medical Devices, Product Launch, Cardiology, Vascular, Capital Equipment, Market Development, Interventional..., Surgeons, Operating Room, Disposables, Orthopedic, Cath Lab, Cardiac Surgery, Spine, ENT, Clinical Research
Education
The University of Memphis
BA, Marketing
Webb School
Invuity Inc August 2010 - August 2011
Evalve, Inc. August 2004 - November 2009
Baxter Healthcare/ Fusion Medical November 1999 - August 2004
Sulzer Vascutek April 1999 - November 1999
Cardima July 1997 - April 1999
Advanced Cardiovascular Systems/ Guidant September 1994 - July 1997
Intervascular,Inc January 1987 - September 1994
Skills
Medical Devices, Product Launch, Cardiology, Vascular, Capital Equipment, Market Development, Interventional..., Surgeons, Operating Room, Disposables, Orthopedic, Cath Lab, Cardiac Surgery, Spine, ENT, Clinical Research
Education
The University of Memphis
BA, Marketing
Webb School
Julia Beal's Evalve, Inc. Experience 2004 - September 2008
Job MA, Protein Sciences @ Genentech / CMT, Essentially Massage
Industry Biotechnology
Bryan Mao Bryan Mao's Evalve, Inc. Experience April 2009 - August 2009
Job Business Operations and Analytics at Bloomboard
Industry Internet
Experience
BloomBoard, Inc. July 2012 - Present
NewGoTos December 2009 - May 2012
Milo.com June 2010 - September 2010
Evalve, Inc. April 2009 - August 2009
XTENT, Inc. June 2005 - March 2009
Department of Veterans Affairs - Rehabilitation R&D Center June 2004 - June 2005
Education
University of California, Berkeley - Walter A. Haas School of Business 2009 — 2011
Master of Business Administration (M.B.A.), Entrepreneurship, Management of Technology
Stanford University 2004 — 2005
Master’s Degree, Mechanical Engineering Design
Vanderbilt University 2000 — 2004
BE, Mechanical Engineering
BloomBoard, Inc. July 2012 - Present
NewGoTos December 2009 - May 2012
Milo.com June 2010 - September 2010
Evalve, Inc. April 2009 - August 2009
XTENT, Inc. June 2005 - March 2009
Department of Veterans Affairs - Rehabilitation R&D Center June 2004 - June 2005
Education
University of California, Berkeley - Walter A. Haas School of Business 2009 — 2011
Master of Business Administration (M.B.A.), Entrepreneurship, Management of Technology
Stanford University 2004 — 2005
Master’s Degree, Mechanical Engineering Design
Vanderbilt University 2000 — 2004
BE, Mechanical Engineering
Julia Beal Julia Beal's Evalve, Inc. Experience Clinical Research AssociateEvalve, Inc.February 2006 - September 2007
Job Clinical Research Associate II at Evalve, Inc.' Owner Essentially Massage and Lion Paw Production
Industry Medical Devices
Experience
Evalve, Inc. Clinical Research AssociateEvalve, Inc.February 2006 - September 2007
Evalve, Inc. August 2004 - February 2006
First Clinical Research December 2003 - August 2004
Radiant Research April 2003 - December 2003
Illumina October 2000 - March 2003
Education
De Anza College
Phlebotomy/Lab Assisting
Indiana University Bloomington
Graphic Design
International Professional School of Bodywork
Massage Therapy
Evalve, Inc. Clinical Research AssociateEvalve, Inc.February 2006 - September 2007
Evalve, Inc. August 2004 - February 2006
First Clinical Research December 2003 - August 2004
Radiant Research April 2003 - December 2003
Illumina October 2000 - March 2003
Education
De Anza College
Phlebotomy/Lab Assisting
Indiana University Bloomington
Graphic Design
International Professional School of Bodywork
Massage Therapy
Liz McDermott Liz McDermott's Evalve, Inc. Experience 2001 - 2009
Job Med Tech product development consultant
Industry Medical Devices
Experience
Abbott Vascular 2009 - 2014
Evalve, Inc. 2001 - 2009
Guidant 1997 - 2000
Endovascular Technologies, Inc. 1996 - 1998
Contact Lens Institute 1995 - 1996
Pilkington Barns Hind 1994 - 1996
Eli Lilly 1985 - 1994
Advanced Cardiovascular Systems, Inc 1984 - 1985
Norton Healthcare 1982 - 1984
Rehabilitation Engineering Center, CWRU 1980 - 1982
Skills
FDA, Design Control, Biomedical Engineering, ISO 13485, Market Development, R&D, Cardiology, Quality System, Biotechnology, CAPA, Product Launch, Product Development, Global Marketing, Capital Equipment, Cross-functional Team..., Clinical Trials, Nitinol, Clinical Research, Commercialization, Opthamology, Interventional..., ISO 14971, Vascular, Catheters, PMA, Stents, Biomaterials, Cath Lab, CE marking, Biocompatibility, 21 CFR, Medical Device R, Medical Devices, V&V
Education
Case Western Reserve University
BS, MS, Biomedical engineering
Indiana University Bloomington
Executive MBA
Abbott Vascular 2009 - 2014
Evalve, Inc. 2001 - 2009
Guidant 1997 - 2000
Endovascular Technologies, Inc. 1996 - 1998
Contact Lens Institute 1995 - 1996
Pilkington Barns Hind 1994 - 1996
Eli Lilly 1985 - 1994
Advanced Cardiovascular Systems, Inc 1984 - 1985
Norton Healthcare 1982 - 1984
Rehabilitation Engineering Center, CWRU 1980 - 1982
Skills
FDA, Design Control, Biomedical Engineering, ISO 13485, Market Development, R&D, Cardiology, Quality System, Biotechnology, CAPA, Product Launch, Product Development, Global Marketing, Capital Equipment, Cross-functional Team..., Clinical Trials, Nitinol, Clinical Research, Commercialization, Opthamology, Interventional..., ISO 14971, Vascular, Catheters, PMA, Stents, Biomaterials, Cath Lab, CE marking, Biocompatibility, 21 CFR, Medical Device R, Medical Devices, V&V
Education
Case Western Reserve University
BS, MS, Biomedical engineering
Indiana University Bloomington
Executive MBA
Daniel Greathouse Daniel Greathouse's Evalve, Inc. Experience June 2008 - October 2009
Job IT Manager at Abbott Laboratories
Industry Medical Devices
Experience
Abbott Laboratories January 2012 - Present
Abbott Vascular Devices January 2011 - January 2012
Abbott Vascular Structural Heart October 2009 - January 2011
Evalve, Inc. June 2008 - October 2009
Aronson & Associates July 2006 - June 2009
Skills
CEH, MCSA Windows Server 2008, RHCSA, VCP, MCITP Enterprise..., MCITP Enterprise..., MCSA Windows 7, MCITP Server..., Security+, MCTS: Windows Server..., MCTS: Windows Server..., MCTS: Windows Server..., MCTS Windows 7,..., Windows 7, Active Directory, Configurations, Microsoft Certified..., MCSA, 2008 R2, VMware, Cross-functional Team..., Windows Server, RHCE, Project Management, Networking, FDA, Integration, Aquisition, Firewalls, Security, Management, ISO 13485, Quality System..., SOX Compliancy, Infrastructure..., Infrastructure..., Infrastructure Services, Change Control, Enterprise Desktop..., Validation, Software Documentation, Computer System..., Databases, System Deployment, Information Technology, IT Management, Telecommunications, Medical Devices
Education
San Diego State University-California State University 2002 — 2004
Global Knowledge
Abbott Laboratories January 2012 - Present
Abbott Vascular Devices January 2011 - January 2012
Abbott Vascular Structural Heart October 2009 - January 2011
Evalve, Inc. June 2008 - October 2009
Aronson & Associates July 2006 - June 2009
Skills
CEH, MCSA Windows Server 2008, RHCSA, VCP, MCITP Enterprise..., MCITP Enterprise..., MCSA Windows 7, MCITP Server..., Security+, MCTS: Windows Server..., MCTS: Windows Server..., MCTS: Windows Server..., MCTS Windows 7,..., Windows 7, Active Directory, Configurations, Microsoft Certified..., MCSA, 2008 R2, VMware, Cross-functional Team..., Windows Server, RHCE, Project Management, Networking, FDA, Integration, Aquisition, Firewalls, Security, Management, ISO 13485, Quality System..., SOX Compliancy, Infrastructure..., Infrastructure..., Infrastructure Services, Change Control, Enterprise Desktop..., Validation, Software Documentation, Computer System..., Databases, System Deployment, Information Technology, IT Management, Telecommunications, Medical Devices
Education
San Diego State University-California State University 2002 — 2004
Global Knowledge
Jake Le Jake Le's Evalve, Inc. Experience June 2006 - April 2008
Job Director of Research & Development at Blockade Medical
Industry Medical Devices
Experience
Blockade Medical January 2015 - Present
Blockade Medical November 2011 - Present
MicroVention June 2009 - November 2011
MicroVention May 2008 - June 2009
Evalve, Inc. June 2006 - April 2008
St. Jude Medical July 2004 - June 2006
Skills
Six Sigma Green Belt, Solidworks, Minitab
Education
University of Colorado at Boulder 1998 — 2003
BS, Electrical Engineering
Blockade Medical January 2015 - Present
Blockade Medical November 2011 - Present
MicroVention June 2009 - November 2011
MicroVention May 2008 - June 2009
Evalve, Inc. June 2006 - April 2008
St. Jude Medical July 2004 - June 2006
Skills
Six Sigma Green Belt, Solidworks, Minitab
Education
University of Colorado at Boulder 1998 — 2003
BS, Electrical Engineering
Reeta Whitney Reeta Whitney's Evalve, Inc. Experience August 2006 - August 2007
Job Senior Corporate Counsel at Varian Medical Systems
Industry Law Practice
Experience
Varian Medical Systems April 2014 - Present
Merz Aesthetics Inc. September 2011 - March 2014
Ropes & Gray LLP January 2007 - April 2011
Evalve, Inc. August 2006 - August 2007
Fish & Neave LLP (merged with Ropes & Gray) October 2002 - July 2006
RITA Medical Systems January 1999 - December 1999
Cardiogenesis Corporation January 1995 - January 1999
Skills
Patents, Patent Litigation, Patent Prosecution, Intellectual Property, Registered Patent..., Client Counseling, Trademarks, Patentability, Prosecution, Medical Devices, Patent Applications, Privacy Law, Invention, Trade Secrets, Freedom to Operate, Trademark Infringement, Copyright Law, Start-ups, Litigation, Civil Litigation, Intellectual Property..., Intellectual Asset..., Licensing, Corporate Law
Education
Santa Clara University School of Law 1999 — 2002
J.D. magna cum laude, Intellectual Property Law
United States Naval Academy 1978 — 1982
B.S., Chemistry
Varian Medical Systems April 2014 - Present
Merz Aesthetics Inc. September 2011 - March 2014
Ropes & Gray LLP January 2007 - April 2011
Evalve, Inc. August 2006 - August 2007
Fish & Neave LLP (merged with Ropes & Gray) October 2002 - July 2006
RITA Medical Systems January 1999 - December 1999
Cardiogenesis Corporation January 1995 - January 1999
Skills
Patents, Patent Litigation, Patent Prosecution, Intellectual Property, Registered Patent..., Client Counseling, Trademarks, Patentability, Prosecution, Medical Devices, Patent Applications, Privacy Law, Invention, Trade Secrets, Freedom to Operate, Trademark Infringement, Copyright Law, Start-ups, Litigation, Civil Litigation, Intellectual Property..., Intellectual Asset..., Licensing, Corporate Law
Education
Santa Clara University School of Law 1999 — 2002
J.D. magna cum laude, Intellectual Property Law
United States Naval Academy 1978 — 1982
B.S., Chemistry
Lorie Laird's Evalve, Inc. Experience August 2009 - March 2010
Job Regulatory Affairs Manager & Clinical Study Support
Industry Medical Devices
Experience
Scanadu September 2014 - Present
Bayer Pharmaceuticals August 2012 - July 2014
Conceptus March 2010 - August 2012
Evalve, Inc. August 2009 - March 2010
VNUS Medical Technologies, Inc. January 2007 - August 2008
W.L. Gore & Associates 1999 - 2006
Fox Hollow Technologies 1997 - 1999
Guidant 1994 - 1997
Skills
Medical Devices, FDA, ISO 13485, Catheters, Quality System, Validation, CAPA, R&D, Design Control, Cross-functional Team..., Manufacturing
Education
Santa Clara University 1997 — 2000
Studied, Engineering Management
California Polytechnic State University-San Luis Obispo 1990 — 1993
BS, Mechanical Engineering
Scanadu September 2014 - Present
Bayer Pharmaceuticals August 2012 - July 2014
Conceptus March 2010 - August 2012
Evalve, Inc. August 2009 - March 2010
VNUS Medical Technologies, Inc. January 2007 - August 2008
W.L. Gore & Associates 1999 - 2006
Fox Hollow Technologies 1997 - 1999
Guidant 1994 - 1997
Skills
Medical Devices, FDA, ISO 13485, Catheters, Quality System, Validation, CAPA, R&D, Design Control, Cross-functional Team..., Manufacturing
Education
Santa Clara University 1997 — 2000
Studied, Engineering Management
California Polytechnic State University-San Luis Obispo 1990 — 1993
BS, Mechanical Engineering
Sandeep Saboo's Evalve, Inc. Experience January 2002 - March 2006
Job Medical Device Quality Assurance, Regulatory Compliance & Regulatory Affairs consulting and training
Industry Medical Devices
Experience
Medical Device Quality/Regulatory Consulting April 2014 - Present
DFine, Inc. March 2006 - April 2014
Evalve, Inc. January 2002 - March 2006
Intella Interventional Systems, Inc. 2000 - 2002
Fox Hollow Technologies 1998 - 2000
Heartport 1994 - 1998
Medtronic Vascular February 1991 - December 1994
Skills
ISO 13485, Medical Devices, Design Control, FDA, Quality System, CAPA, R&D, Validation, GMP, Manufacturing, Root Cause Analysis, V&V, Design of Experiments, Product Development, Biomedical Engineering, Regulatory Affairs, Quality Assurance, Clinical Trials, Cross-functional Team..., SPC, Product Launch, FMEA, Market Development, Commercialization, ISO, Design for Manufacturing, ISO 14971, Six Sigma, Biotechnology, Injection Molding, Capital Equipment, Strategy, Change Control, Lean Manufacturing, DMAIC, Failure Analysis, Disposables, Solidworks, Quality Auditing, Orthopedic, Hardware Diagnostics, 21 CFR Part 11, Supplier Quality, Quality Control, Testing, CE marking, Start-ups, Medical Device Directive, Contract Manufacturing
Education
University of Massachusetts, Amherst 1987 — 1989
Master of Science (MS), Industrial Engineering & Operations Research
Birla Institute of Technology 1982 — 1986
B.S. (Engg), Mechanical Engineering
Scindia School 1975 — 1982
High School Graduate, School
Medical Device Quality/Regulatory Consulting April 2014 - Present
DFine, Inc. March 2006 - April 2014
Evalve, Inc. January 2002 - March 2006
Intella Interventional Systems, Inc. 2000 - 2002
Fox Hollow Technologies 1998 - 2000
Heartport 1994 - 1998
Medtronic Vascular February 1991 - December 1994
Skills
ISO 13485, Medical Devices, Design Control, FDA, Quality System, CAPA, R&D, Validation, GMP, Manufacturing, Root Cause Analysis, V&V, Design of Experiments, Product Development, Biomedical Engineering, Regulatory Affairs, Quality Assurance, Clinical Trials, Cross-functional Team..., SPC, Product Launch, FMEA, Market Development, Commercialization, ISO, Design for Manufacturing, ISO 14971, Six Sigma, Biotechnology, Injection Molding, Capital Equipment, Strategy, Change Control, Lean Manufacturing, DMAIC, Failure Analysis, Disposables, Solidworks, Quality Auditing, Orthopedic, Hardware Diagnostics, 21 CFR Part 11, Supplier Quality, Quality Control, Testing, CE marking, Start-ups, Medical Device Directive, Contract Manufacturing
Education
University of Massachusetts, Amherst 1987 — 1989
Master of Science (MS), Industrial Engineering & Operations Research
Birla Institute of Technology 1982 — 1986
B.S. (Engg), Mechanical Engineering
Scindia School 1975 — 1982
High School Graduate, School
Mairead Donohue's Evalve, Inc. Experience July 2005 - July 2009
Job Human Resources Consultant and Contractor
Industry Human Resources
Experience
Evalve, Inc. July 2005 - July 2009
General Surgical Innovations (GSI) June 1996 - December 1998
Becton Dickinson April 1980 - June 1996
Education
New York Law School 1975 — 1979
JD, American Studies
Manhattanville College 1969 — 1973
BA, American Studies
Evalve, Inc. July 2005 - July 2009
General Surgical Innovations (GSI) June 1996 - December 1998
Becton Dickinson April 1980 - June 1996
Education
New York Law School 1975 — 1979
JD, American Studies
Manhattanville College 1969 — 1973
BA, American Studies
Sarita Dave's Evalve, Inc. Experience October 2009 - Present
Job Senior Quality Engineer at Evalve, Inc.
Industry Medical Devices
Experience
Evalve, Inc. October 2009 - Present
Abbott Vascular 2009 - Present
LifeScan April 1991 - October 2009
LifeScan, a Johnson & Johnson company April 1991 - October 2009
Intel August 1987 - February 1991
Skills
Manufacturing, Quality Assurance, Design Control, Validation, Medical Devices, Green Belt, Biomedical Engineering, Six Sigma, Quality System, Cross-functional Team..., Quality Control, 21 CFR Part 11, Engineering, Product Development, Product Innovation, ISO 14971, Troubleshooting, FDA, Catheters, FMEA, GMP, CAPA, Change Control, Supplier Quality, Process Excellence, GD&T, Manufacturing..., ISO 13485, Visio, Product Launch, V&V, Design for Manufacturing, Minitab, Lifesciences, Calibration, Biotechnology, Product Management, Root Cause Analysis, R&D, CQA, CE marking, 21 CFR, Design of Experiments, SPC, DMAIC, Computer System..., FDA GMP, Quality Auditing
Education
University of California, Santa Cruz 1997 — 1998
certificate, Information Systems and Technology
Delhi University 1981 — 1984
Evalve, Inc. October 2009 - Present
Abbott Vascular 2009 - Present
LifeScan April 1991 - October 2009
LifeScan, a Johnson & Johnson company April 1991 - October 2009
Intel August 1987 - February 1991
Skills
Manufacturing, Quality Assurance, Design Control, Validation, Medical Devices, Green Belt, Biomedical Engineering, Six Sigma, Quality System, Cross-functional Team..., Quality Control, 21 CFR Part 11, Engineering, Product Development, Product Innovation, ISO 14971, Troubleshooting, FDA, Catheters, FMEA, GMP, CAPA, Change Control, Supplier Quality, Process Excellence, GD&T, Manufacturing..., ISO 13485, Visio, Product Launch, V&V, Design for Manufacturing, Minitab, Lifesciences, Calibration, Biotechnology, Product Management, Root Cause Analysis, R&D, CQA, CE marking, 21 CFR, Design of Experiments, SPC, DMAIC, Computer System..., FDA GMP, Quality Auditing
Education
University of California, Santa Cruz 1997 — 1998
certificate, Information Systems and Technology
Delhi University 1981 — 1984
Leslie Coleman's Evalve, Inc. Experience December 2008 - August 2010
Job Sr Director, Medical Affairs at ReCor Medical
Industry Medical Devices
Experience
ReCor Medical May 2013 - Present
Abbott Vascular November 2009 - April 2013
Evalve, Inc. December 2008 - August 2010
Abbott Vascular April 2006 - December 2008
Guidant Corporation 1999 - 2006
Skills
Medical Devices, Clinical Research, Medical Affairs, Medicine, Clinical Trials, FDA, Cardiology, Biotechnology, Regulatory Affairs, Pharmaceutical Industry, Oncology, GCP, CTMS, Regulatory Submissions, Lifesciences, CRO
Education
Massachusetts Institute of Technology 1994 — 1997
MS, Toxicology
University of CA,Davis School of Veterinary medicine 1988 — 1992
DVM, Veterinary Medicine
Smith College 1982 — 1986
BA, Biology
ReCor Medical May 2013 - Present
Abbott Vascular November 2009 - April 2013
Evalve, Inc. December 2008 - August 2010
Abbott Vascular April 2006 - December 2008
Guidant Corporation 1999 - 2006
Skills
Medical Devices, Clinical Research, Medical Affairs, Medicine, Clinical Trials, FDA, Cardiology, Biotechnology, Regulatory Affairs, Pharmaceutical Industry, Oncology, GCP, CTMS, Regulatory Submissions, Lifesciences, CRO
Education
Massachusetts Institute of Technology 1994 — 1997
MS, Toxicology
University of CA,Davis School of Veterinary medicine 1988 — 1992
DVM, Veterinary Medicine
Smith College 1982 — 1986
BA, Biology
Xingyan (Sarah) Bai's Evalve, Inc. Experience 2010 - Present
Job Statistician
Industry Information Technology and Services
Experience
Abbott Vascular Structural Heart January 2010 - Present
Evalve, Inc. 2010 - Present
Roche Molecular Systems 2011 - 2012
Genomic Health February 2008 - January 2010
Skills
Clinical Trials, FDA, SAS, SQL, Matlab, R, Clinical Development, Statistics, Data Analysis, Lifesciences, Statistical Modeling, Data Mining, SAS programming, Statistical Programming, CDISC, Data Management, EDC, Validation, Minitab, Programming, Unix
Education
California State University-East Bay 2007 — 2007
University of Missouri-Rolla 2000 — 2004
PhD, Mechanical Engineering
Abbott Vascular Structural Heart January 2010 - Present
Evalve, Inc. 2010 - Present
Roche Molecular Systems 2011 - 2012
Genomic Health February 2008 - January 2010
Skills
Clinical Trials, FDA, SAS, SQL, Matlab, R, Clinical Development, Statistics, Data Analysis, Lifesciences, Statistical Modeling, Data Mining, SAS programming, Statistical Programming, CDISC, Data Management, EDC, Validation, Minitab, Programming, Unix
Education
California State University-East Bay 2007 — 2007
University of Missouri-Rolla 2000 — 2004
PhD, Mechanical Engineering
Sean Cleary's Evalve, Inc. Experience August 2008 - November 2009
Job Vice President, Global Market Development at Inspire Medical Systems
Industry Medical Devices
Experience
Inspire Medical Systems September 2014 - Present
Abbott Vascular Devices November 2009 - November 2012
Evalve, Inc. August 2008 - November 2009
Boston Scientific January 2007 - January 2008
Guidant Corporation October 2004 - December 2006
Guidant Corporation October 2002 - October 2004
Guidant December 1999 - October 2002
Incontrol, Inc. 1997 - 1999
Skills
Market Development, Medical Devices, Product Launch, Cardiology, Global Marketing, Commercialization, Cross-functional Team..., Marketing, Sales Effectiveness, Operating Room, FDA, Competitive Analysis, Product Marketing, Product Development, Biotechnology, Product Management, Selling Skills, New Business Development, Acquisition Integration, Cardiac Surgery, Mergers & Acquisitions, Human Resources, Global Business..., Start-ups, Strategic Planning, Clinical Trials, Health Economics, Executive Management, Sales Compensation, Employee Training, Leadership Development
Education
University of Michigan - Stephen M. Ross School of Business 1985 — 1987
Master of Business Administration (MBA) with Distinction, Marketing & Finance
University of Michigan College of Engineering 1976 — 1980
BSE, Industrial & Operations Engineering
Inspire Medical Systems September 2014 - Present
Abbott Vascular Devices November 2009 - November 2012
Evalve, Inc. August 2008 - November 2009
Boston Scientific January 2007 - January 2008
Guidant Corporation October 2004 - December 2006
Guidant Corporation October 2002 - October 2004
Guidant December 1999 - October 2002
Incontrol, Inc. 1997 - 1999
Skills
Market Development, Medical Devices, Product Launch, Cardiology, Global Marketing, Commercialization, Cross-functional Team..., Marketing, Sales Effectiveness, Operating Room, FDA, Competitive Analysis, Product Marketing, Product Development, Biotechnology, Product Management, Selling Skills, New Business Development, Acquisition Integration, Cardiac Surgery, Mergers & Acquisitions, Human Resources, Global Business..., Start-ups, Strategic Planning, Clinical Trials, Health Economics, Executive Management, Sales Compensation, Employee Training, Leadership Development
Education
University of Michigan - Stephen M. Ross School of Business 1985 — 1987
Master of Business Administration (MBA) with Distinction, Marketing & Finance
University of Michigan College of Engineering 1976 — 1980
BSE, Industrial & Operations Engineering
Jaime Sarabia's Evalve, Inc. Experience July 2001 - January 2009
Job Medical Device Entrepreneur
Industry Medical Devices
Experience
Self -Employed December 2014 - Present
Abbott Vascular Structural Heart June 2010 - November 2014
Abbott Vascular-Structural Heart (Formerly Evalve, Inc.) January 2009 - June 2010
Evalve, Inc. July 2001 - January 2009
W.L. Gore & Associates July 1998 - July 2001
Skills
Sales, Medical Devices, FDA, R&D, Product Development, Cath Lab, Design Control, Product Management, Product Marketing, Start-ups, Physicians, Clinical Support, Commercialization, Interventional..., Product Launch, Cardiology, Product Design, Vascular
Education
Massachusetts Institute of Technology 1994 — 1998
Bachelors of Science, Mechanical Engineering, Economics
Self -Employed December 2014 - Present
Abbott Vascular Structural Heart June 2010 - November 2014
Abbott Vascular-Structural Heart (Formerly Evalve, Inc.) January 2009 - June 2010
Evalve, Inc. July 2001 - January 2009
W.L. Gore & Associates July 1998 - July 2001
Skills
Sales, Medical Devices, FDA, R&D, Product Development, Cath Lab, Design Control, Product Management, Product Marketing, Start-ups, Physicians, Clinical Support, Commercialization, Interventional..., Product Launch, Cardiology, Product Design, Vascular
Education
Massachusetts Institute of Technology 1994 — 1998
Bachelors of Science, Mechanical Engineering, Economics
Eric Goldfarb's Evalve, Inc. Experience January 2000 - January 2006
Job VP R&D at ExploraMed NC6
Industry Medical Devices
Experience
ExploraMed NC6 January 2014 - Present
ExploraMed Development, L.L.C. January 2012 - Present
Acclarent January 2006 - October 2011
Evalve, Inc. January 2000 - January 2006
Education
Stanford University 1997 — 1999
MSME
Dartmouth College
BA, Biology
ExploraMed NC6 January 2014 - Present
ExploraMed Development, L.L.C. January 2012 - Present
Acclarent January 2006 - October 2011
Evalve, Inc. January 2000 - January 2006
Education
Stanford University 1997 — 1999
MSME
Dartmouth College
BA, Biology
Christopher Dauer's Evalve, Inc. Experience March 2004 - October 2008
Job Director, Marketing & Strategic Communications at Hoover Institution
Industry Think Tanks
Experience
The Hoover Institution September 2011 - Present
Ursa Technology Partners May 2009 - Present
Invuity Inc April 2010 - September 2011
Hoover Institution June 2009 - April 2010
Evalve, Inc. March 2004 - October 2008
St. Francis Medical Technologies, Inc September 2002 - January 2004
Fusion Medical Technologies 1996 - 2002
Advanced Cardiovascular Systems/Guidant 1990 - 1996
Education
Stanford University Graduate School of Business 1989 — 1991
MBA
Brown University 1981 — 1985
The Hoover Institution September 2011 - Present
Ursa Technology Partners May 2009 - Present
Invuity Inc April 2010 - September 2011
Hoover Institution June 2009 - April 2010
Evalve, Inc. March 2004 - October 2008
St. Francis Medical Technologies, Inc September 2002 - January 2004
Fusion Medical Technologies 1996 - 2002
Advanced Cardiovascular Systems/Guidant 1990 - 1996
Education
Stanford University Graduate School of Business 1989 — 1991
MBA
Brown University 1981 — 1985
Sylvia Erickson's Evalve, Inc. Experience 1999 - 2005
Job Medical Device Regulatory Affairs Consultant
Industry Medical Devices
Experience
Sylvia Erickson Consulting 2006 - Present
Concentric Medical/ Stryker Neurovascular 2006 - June 2013
Evalve, Inc. 1999 - 2005
Heartport, Inc. 1994 - 1998
Skills
Medical Devices, Design Control, FDA, CAPA, ISO 13485
Education
Stanford University
M.S, Mechanical Engineering
Stanford University
B.S., Mechanical Engineering
Sylvia Erickson Consulting 2006 - Present
Concentric Medical/ Stryker Neurovascular 2006 - June 2013
Evalve, Inc. 1999 - 2005
Heartport, Inc. 1994 - 1998
Skills
Medical Devices, Design Control, FDA, CAPA, ISO 13485
Education
Stanford University
M.S, Mechanical Engineering
Stanford University
B.S., Mechanical Engineering
Emmanuelle Pease's Evalve, Inc. Experience September 2007 - September 2009
Job R&D and Operations Manager at ReVENT Medical, Inc.
Industry Medical Devices
Experience
ReVENT Medical, Inc. August 2014 - Present
ReVENT Medical August 2012 - August 2014
Abbott Vascular September 2009 - September 2011
Evalve, Inc. September 2007 - September 2009
OsteoMed June 2006 - August 2006
Skills
Medical Devices, R&D, Biomedical Engineering, Design Development, Leading Projects, Solidworks, FDA, Design with nitinol, Packaging Engineering, Injection Molding Design, Validation, Statistics
Education
The University of Texas at Austin 2002 — 2007
BS, Biomedical Engineering
ReVENT Medical, Inc. August 2014 - Present
ReVENT Medical August 2012 - August 2014
Abbott Vascular September 2009 - September 2011
Evalve, Inc. September 2007 - September 2009
OsteoMed June 2006 - August 2006
Skills
Medical Devices, R&D, Biomedical Engineering, Design Development, Leading Projects, Solidworks, FDA, Design with nitinol, Packaging Engineering, Injection Molding Design, Validation, Statistics
Education
The University of Texas at Austin 2002 — 2007
BS, Biomedical Engineering
Heidrun Roscher's Evalve, Inc. Experience 2002 - 2003
Job Medical Devices Professional
Industry Medical Devices
Experience
VivoMedical 2006 - 2007
FoxHollow Technologies 2005 - 2005
Celerity 2004 - 2004
SurgRx 2004 - 2004
Evalve, Inc. 2002 - 2003
Conceptus 2002 - 2002
Amira Medical 1999 - 2002
Boehringer Mannheim 1994 - 1999
Education
San Jose City College
A. A., Computer Information Systems
VivoMedical 2006 - 2007
FoxHollow Technologies 2005 - 2005
Celerity 2004 - 2004
SurgRx 2004 - 2004
Evalve, Inc. 2002 - 2003
Conceptus 2002 - 2002
Amira Medical 1999 - 2002
Boehringer Mannheim 1994 - 1999
Education
San Jose City College
A. A., Computer Information Systems
Barathi Sethuraman's Evalve, Inc. Experience November 2008 - October 2009
Job Vice President, Clinical Science at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical March 2015 - Present
Coherex Medical March 2014 - February 2015
Abbott Vascular Structural Heart October 2009 - February 2014
Evalve, Inc. November 2008 - October 2009
St. Jude Medical - CRMD 2000 - 2008
LifeScan 1998 - 2000
Skills
People Management, Organizational..., Process Development, Process Management, Medical Devices, Data Management, Statistics, Clinical Study Design, FDA, Clinical Trials, Clinical Research, Biomedical Engineering, Clinical Development, Biostatistics, PMA, EDC, GCP, Biotechnology, CTMS, Cardiology, Data Analysis, IDE
Education
University of California, Berkeley 1991 — 1997
Ph.D, Statistics
Indian Institute of Technology, Kanpur 1985 — 1990
Master of Science, Statistics
St. Jude Medical March 2015 - Present
Coherex Medical March 2014 - February 2015
Abbott Vascular Structural Heart October 2009 - February 2014
Evalve, Inc. November 2008 - October 2009
St. Jude Medical - CRMD 2000 - 2008
LifeScan 1998 - 2000
Skills
People Management, Organizational..., Process Development, Process Management, Medical Devices, Data Management, Statistics, Clinical Study Design, FDA, Clinical Trials, Clinical Research, Biomedical Engineering, Clinical Development, Biostatistics, PMA, EDC, GCP, Biotechnology, CTMS, Cardiology, Data Analysis, IDE
Education
University of California, Berkeley 1991 — 1997
Ph.D, Statistics
Indian Institute of Technology, Kanpur 1985 — 1990
Master of Science, Statistics
Trish Kuper, RN, CCRA's Evalve, Inc. Experience March 2009 - May 2014
Job Senior Clinical Research Associate at Theorem Clinical Research
Industry Research
Experience
Chiltern September 2015 - Present
Theorem Clinical Research May 2014 - Present
Abbott Vascular Structural Heart October 2009 - May 2014
Evalve, Inc. March 2009 - May 2014
Self Employed December 2008 - March 2009
Integrium April 2008 - December 2008
Bailer Research February 2002 - April 2008
Mid Carolina Cardiology September 2001 - February 2003
Skills
CCRA, EDC, Clinical Research, FDA, Clinical Trials, Clinical Monitoring, Medical Devices, CTMS, GCP, Cardiology, CRO, Clinical Development, ICH-GCP, Regulatory Affairs
Education
Carolinas College of Health Sciences 1992 — 1994
ADN, Nursing
University of North Carolina at Charlotte 1981 — 1983
Bachelor of Arts (BA), English
Chiltern September 2015 - Present
Theorem Clinical Research May 2014 - Present
Abbott Vascular Structural Heart October 2009 - May 2014
Evalve, Inc. March 2009 - May 2014
Self Employed December 2008 - March 2009
Integrium April 2008 - December 2008
Bailer Research February 2002 - April 2008
Mid Carolina Cardiology September 2001 - February 2003
Skills
CCRA, EDC, Clinical Research, FDA, Clinical Trials, Clinical Monitoring, Medical Devices, CTMS, GCP, Cardiology, CRO, Clinical Development, ICH-GCP, Regulatory Affairs
Education
Carolinas College of Health Sciences 1992 — 1994
ADN, Nursing
University of North Carolina at Charlotte 1981 — 1983
Bachelor of Arts (BA), English
Antonette Esteban's Evalve, Inc. Experience March 2010 - June 2010
Job Clinical
Industry Medical Devices
Experience
Abbott March 2014 - Present
Abbott February 2014 - March 2014
Abbott December 2012 - February 2014
ABBOTT VASUCLAR March 2010 - December 2012
Evalve, Inc. March 2010 - June 2010
LIFESCAN, INC June 2008 - October 2009
LIFESCAN, INC October 2005 - January 2009
LifeScan September 2005 - April 2008
LifeScan September 2005 - April 2008
LifeScan January 2001 - January 2005
Skills
GLP, Quality Control, Validation, Data Analysis, GMP
Education
San Jose State University
Bachelor of Science, Biology, General
San Jose State University
Bachelor of Science, Biology, General
Abbott March 2014 - Present
Abbott February 2014 - March 2014
Abbott December 2012 - February 2014
ABBOTT VASUCLAR March 2010 - December 2012
Evalve, Inc. March 2010 - June 2010
LIFESCAN, INC June 2008 - October 2009
LIFESCAN, INC October 2005 - January 2009
LifeScan September 2005 - April 2008
LifeScan September 2005 - April 2008
LifeScan January 2001 - January 2005
Skills
GLP, Quality Control, Validation, Data Analysis, GMP
Education
San Jose State University
Bachelor of Science, Biology, General
San Jose State University
Bachelor of Science, Biology, General
Danny Argonza's Evalve, Inc. Experience February 2009 - April 2009
Job Sr. Engineer, R&D at Stryker Neurovascular
Industry Medical Devices
Experience
Stryker Neurovascular March 2015 - Present
Stryker Neurovascular December 2011 - Present
Invuity Inc July 2010 - November 2011
Invuity Inc May 2010 - June 2010
Evalve, Inc. February 2009 - April 2009
DURECT Corporation June 2001 - December 2008
Eclipse Surgical Technologies November 2000 - June 2001
LifeScan February 1997 - November 2000
LifeScan November 1995 - February 1997
Skills
Medical Devices, Design Control, FDA, Validation, R&D, ISO 13485, Materials, CAPA, Design for Assembly, GMP, Quality System, Design of Experiments, Technical Documentation, Equipment Maintenance, Equipment Installation, Leadership, Mechanical Engineering, Laboratory Equipment, V&V, Design for Manufacturing
Education
San Jose State University
BS, Aerospace Engineering
Stryker Neurovascular March 2015 - Present
Stryker Neurovascular December 2011 - Present
Invuity Inc July 2010 - November 2011
Invuity Inc May 2010 - June 2010
Evalve, Inc. February 2009 - April 2009
DURECT Corporation June 2001 - December 2008
Eclipse Surgical Technologies November 2000 - June 2001
LifeScan February 1997 - November 2000
LifeScan November 1995 - February 1997
Skills
Medical Devices, Design Control, FDA, Validation, R&D, ISO 13485, Materials, CAPA, Design for Assembly, GMP, Quality System, Design of Experiments, Technical Documentation, Equipment Maintenance, Equipment Installation, Leadership, Mechanical Engineering, Laboratory Equipment, V&V, Design for Manufacturing
Education
San Jose State University
BS, Aerospace Engineering
Emilio Casanovas's Evalve, Inc. Experience 2006 - 2007
Job Mechanical Engineer at EC Engineering
Industry Medical Devices
Experience
EC Engineering Mechanical Design Engineer
Boston Scientific 2007 - 2010
Evalve, Inc. 2006 - 2007
Adiana 2001 - 2006
Starion Instruments 2000 - 2001
General Surgical Innovation 1998 - 2000
Aerogen 1995 - 1998
H&R Engineering Consultants 1993 - 1995
Becton Dickinson Immunocytometry System 1987 - 1993
Education
Cogswell Polytechnical College
Bachelor of Science (B.S.), Mechanical Engineering
De Anza College
Associate of Science (A.S.), Engineering technology
EC Engineering Mechanical Design Engineer
Boston Scientific 2007 - 2010
Evalve, Inc. 2006 - 2007
Adiana 2001 - 2006
Starion Instruments 2000 - 2001
General Surgical Innovation 1998 - 2000
Aerogen 1995 - 1998
H&R Engineering Consultants 1993 - 1995
Becton Dickinson Immunocytometry System 1987 - 1993
Education
Cogswell Polytechnical College
Bachelor of Science (B.S.), Mechanical Engineering
De Anza College
Associate of Science (A.S.), Engineering technology
William (Bill) Hyatt's Evalve, Inc. Experience April 2008 - August 2008
Job 20+ Years Regulatory Affairs professional
Industry Medical Devices
Experience
NeuroPace September 2008 - October 2010
Evalve, Inc. April 2008 - August 2008
Medtronic Vascular March 2004 - April 2008
Micro Therapeutics, Inc. (MTI) April 2002 - January 2004
Careside, Inc. November 1997 - April 2002
MRL Diagnostics, Inc. March 1993 - November 1997
Diagnostic Products Corporation November 1989 - March 1993
Education
University of California, Los Angeles
B.A., Political Science
NeuroPace September 2008 - October 2010
Evalve, Inc. April 2008 - August 2008
Medtronic Vascular March 2004 - April 2008
Micro Therapeutics, Inc. (MTI) April 2002 - January 2004
Careside, Inc. November 1997 - April 2002
MRL Diagnostics, Inc. March 1993 - November 1997
Diagnostic Products Corporation November 1989 - March 1993
Education
University of California, Los Angeles
B.A., Political Science
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY