Abbott Vascular Devices
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Abbott Vascular Devices Employees
Abbott Vascular Sr Unix AdminCareFusionSeptember 2009 - Present
CareFusion September 2009 - Present
Apria Healthcare 2008 - Present
Abbott Cardio Vascular Care 2006 - Present
Apria Healthcare September 2008 - August 2009
Abbott Vascular Devices 2006 - 2008
Sony Corporation of America 1998 - 2006
Amdocs 1999 - 1999
ITDS 1991 - 1996
Skills
Unix, SAN, Integration, Vendor Management, Process Improvement, Software Documentation, Disaster Recovery, Project Management, IT Management, SDLC
Education
University of Connecticut 1986 — 1991
Abbott September 2013 - Present
Abbott January 2013 - September 2013
Abbott Vascular August 2012 - January 2013
Abbott Vascular February 2011 - October 2012
Abbott Vascular Devices November 2005 - March 2011
Genentech October 2004 - November 2005
Skills
V&V, Root Cause Analysis, Test Methodologies, FDA, ISO 13485, Quality Assurance, Quality Management, CAPA, FMEA, Validation, Continuous Improvement, Quality Control, Medical Devices, R&D, Design Control, Process Simulation, Quality System
Education
University of California, Berkeley 1999 — 2003
B.S, Bioengineering
Volcano Corporation May 2014 - Present
Abbott Vascular devices May 2012 - May 2014
Cook Medical December 2006 - May 2012
Skills
Capital Equipment, Medical Devices, Operating Room, Surgical Instruments, Surgeons, Sales, Product Launch, Market Development, Cardiology
Education
UC Santa Barbara 2000 — 2004
Bachelor's degree, Political Science and Government
Abbott Vascular Devices September 2006 - Present
Amgen April 2006 - August 2006
Amgen formerly Abgenix October 2003 - April 2006
Abgenix October 2002 - October 2003
Baxter BioScience October 2001 - November 2002
Baxter BioScience July 1998 - October 2001
Silliker November 1996 - June 1998
Diagnostic Laboratories Services/Accupath Hawaii January 1992 - April 1996
Skills
CAPA, FDA, GMP, Validation, Biotechnology, GLP, Sop, Change Control, 21 CFR Part 11, LIMS, Biopharmaceuticals, Aseptic Processing, Microbiology, Pharmaceutical Industry, Medical Devices, GxP, ELISA, Laboratory, Quality Control, SOP
Education
Southwestern University (PH) 1986 — 1990
BS, Medical Technology
Vellez College 1984 — 1986
One Medical Group October 2014 - Present
Practice Fusion April 2013 - October 2014
Abbott Diabetes Care September 2012 - April 2013
Abbott Diabetes Care December 2011 - September 2012
Abbott Diabetes Care November 2010 - December 2011
Abbott Diabetes Care July 2009 - November 2010
Abbott Laboratories July 2007 - July 2009
Abbott Vascular Devices June 2006 - September 2006
Skills
Medical Devices, Cross-functional Team..., Business Development, Manufacturing, Product Development, Pharmaceutical Industry, R&D, Biomedical Engineering, Product Launch, Continuous Improvement, Management, Product Management, Biotechnology, Strategic Planning, Leadership, Global Marketing, Start-ups, FDA, Project Management, Strategy, Regulatory Affairs, Healthcare
Education
University of Pennsylvania - The Wharton School 2015 — 2017
Master of Business Administration (M.B.A.)
University of California, San Diego 2002 — 2007
B.S., Bioengineering
Universidad Complutense de Madrid 2004 — 2005
International Politics
Ronda M Heiser Consulting September 2014 - Present
Acclarent June 2005 - February 2014
Abbott Vascular Devices July 2004 - June 2006
Abbott Vascular Devices July 2001 - July 2005
Perclose September 1999 - June 2001
Philips Medical September 1998 - September 1999
Doctor's Hospital, Columbus, Ohio August 1993 - August 1998
Skills
Cardiology, Clinical Development, Clinical Research, Clinical Trials, Cross-functional Team..., FDA, Healthcare, Interventional Radiology, Market Development, Medical Devices, Neurology, Operating Room, Orthopedic, Product Launch, Surgeons, Surgical Instruments, Biomedical Engineering, Interventional..., Medical Imaging, Clinical Monitoring, Vascular, Commercialization, Surgery, Global Marketing, CAPA, ENT, Hospitals, Sales Force Development, Radiology, Design of Experiments, Cath Lab, Hospital Sales, Medical Sales, Stents, Catheters, Patents, Endovascular, Peripheral Vascular, Surgical Device Sales, Cardiac Surgery, Minimally Invasive..., ISO 13485, Orthopedics
Education
Medical Product Manager Institute
Certificate of Completion, The Effective Product Manager
Medical Product Manager Institute
Certificate of Completion, Strategy Insights for Marketers
Barnett International
Certificate of Completion, Basic Monitoring for Clinical Studies
Barnett International
Certificate of Completion, Clinical Trial Design and Development
The Ohio State University 1995 — 1997
Communication Disorders
University of Cincinnati 1989 — 1992
Associate of Applied Sciences, Medical Radiologic Technology/Science - Radiographer
Norwood
Edwards Lifesciences September 2013 - Present
Edwards Lifesciences October 2011 - October 2013
Abbott Vascular Devices November 2008 - October 2011
Abbott Vascular Devices July 2006 - November 2008
Kimberly-Clark April 2004 - July 2006
Kimberly-Clark April 2002 - April 2004
Kimberly-Clark August 2000 - April 2002
Kimberly-Clark May 1998 - August 2000
Skills
Six Sigma, Lean Manufacturing, Quality System, Cross-functional Team..., Design Control, Product Launch, Manufacturing..., Manufacturing, Supply Chain Management, Medical Devices, Supply Chain, Continuous Improvement, FDA, DMAIC, SPC, CAPA, Manufacturing Operations, Process Control, Spanish, English, Validation, Engineering, GMP, Product Development, Kaizen, FMEA, Minitab, ISO 13485, V&V, R&D, Design for Manufacturing, Program Management, Quality Control, Design of Experiments, ISO, Quality Management, Process Simulation, Root Cause Analysis, Management, Value Stream Mapping, PPAP, Commercialization, Process Engineering, Operations Management, Process Improvement
Education
University of Arizona
MBA, Business
University of Florida
BS, Material Science & Engineering
Creganna Tactx Medical August 2012 - July 2014
Abbott Vascular Structural Heart April 2012 - August 2012
TDC Medical April 2010 - November 2011
Sequoia Sales Solutions September 2008 - April 2010
Abbott Diagnostics April 2008 - September 2008
Abbott Vascular Devices January 2005 - April 2008
Integrated Biosystems, Inc. November 2003 - January 2005
Skills
Lean Manufacturing, Adhesives, Design Control, ISO 13485, Medical Devices, FDA, V&V, CAPA, Biomedical Engineering, Design of Experiments, R&D, Quality System, Minitab, Manufacturing..., Validation, Solidworks, Product Development, FMEA, Design for Manufacturing, ISO 14971
Education
Santa Clara University - Leavey School of Business 2012 — 2015
Master of Business Administration (MBA), Finance, Corporate Strategy
University of California, Davis 1998 — 2003
BS, Biomedical Engineering
AppDirect November 2014 - Present
AppDirect July 2014 - November 2014
AppDirect July 2013 - July 2014
AppDirect February 2012 - July 2013
Bain & Company 2010 - 2012
Beckman Coulter June 2009 - July 2010
Sandia National Laboratories July 2007 - September 2007
Abbott Vascular Devices May 2006 - July 2006
Skills
Excel, Excel modeling, PowerPoint, Engineering, Microsoft Excel, Analytics, Strategic Planning, Mergers & Acquisitions, Acqui-hiring
Education
Stanford University 2007 — 2009
Master of Science, Mechanical Engineering (Biomechanics)
University of California, Berkeley 2003 — 2007
B.S., Mechanical Engineering
Northgate High School 1999 — 2003
High school diploma
Abbott Vascular Devices January 2008 - Present
Abbott Vascular 2005 - 2007
University of Minnesota 2004 - 2005
Oregon Health & Science University 1998 - 2003
Skills
FDA, Clinical Trials, Medical Devices, Biotechnology, Clinical Research, Lifesciences, R&D, Medical Device R&D, Medical Information..., Coronary Artery Disease, Peripheral Vascular, Heart Disease, Molecular Biology, Cell Biology, Stem Cells, Cell Culture, Gene Expression, Animal Models, Medical Affairs, Protein Chemistry, Life Sciences
Education
State University of New York at Buffalo 1993 — 1998
Doctor of Philosophy (Ph.D.), Biological Sciences
Beijing Medical University (renamed as Peking University Health Science Center) 1985 — 1990
Doctor of Medicine (M.D.), Basic Medicine
Lockheed Martin Space Systems Company September 2013 - Present
San Francisco Bay Area Council BSA October 2010 - Present
Lockheed Martin Space Systems Company October 2011 - September 2013
Facilities Management Services, LLC June 2010 - October 2011
San Francisco Bay Area Council BSA June 2011 - July 2011
Dendreon Corporation February 2009 - March 2010
ev3 - FoxHollow Technologies Division June 2005 - January 2009
FoxHollow Technologies March 2005 - August 2005
Abbott Vascular Devices January 2003 - June 2005
ICOM Mechanical June 2001 - January 2003
Skills
Facilities Management, Construction Management, Operations Management, NRA Instructor: Rifle,..., Risk Incident Management, Staff Development, Engineering, Quality System, Construction, Program Management, Budgets, Leadership, Project Management, Security, Management, Vendor Management, Training, Process Improvement, Six Sigma, Contract Negotiation, Cross-functional Team..., HVAC, Risk Management, Contract Management, Human Resources, Strategic Planning, Manufacturing, Medical Devices, Project Planning, Lean Manufacturing, Quality Assurance, Continuous Improvement, Software Documentation, Engineering Management, Electricians, Process Scheduler, Team Building, Procurement, Process Engineering, MS Project, FDA, Quality Management, Validation, Product Development
Education
San Jose State University 1980 — 1997
BS, Industrial Studies - Quality Assurance
Bellarmine College Preparatory
HS diploma
ForSight VISION5 July 2015 - Present
ForSight VISION5 June 2013 - June 2015
Baxano, Inc November 2012 - May 2013
Stryker October 2011 - October 2012
Concentric Medical July 2008 - October 2011
Abbott Vascular Devices January 2007 - July 2008
Abbott Vascular 2007 - 2008
Guidant November 2001 - July 2005
Guidant 1998 - 2001
Guidant: Compass 1998 - 2001
Skills
Clinical Research, Clinical Trials, Medical Devices, 510 K, Stents, FDA, PMA, Biomedical Engineering, Interventional Radiology, Electrophysiology, Neurosurgery, Neuroscience, Biostatistics, Clinical Trial..., Medical Writing, EDC, CTMS, Project Management, People Skills, Clinical Development, GCP, Regulatory Submissions, Regulatory Affairs, Lifesciences, Cardiology, Clinical Study Design, Commercialization, Biotechnology, Clinical Monitoring, Protocol, Design Control, Neurology, Pharmaceutical Industry
Education
University of California, Berkeley 1993 — 1998
PhD, Vision Science (Neuroscience focus)
University of California, Los Angeles 1986 — 1991
BS, Cybernetics (aka Biomedical Engineering)
St. Jude Medical February 2009 - Present
St. Jude Medical October 2007 - February 2009
Abbott Vascular Devices July 2006 - October 2007
Skills
Design for Manufacturing, Design Control, CAD, ISO 13485, Medical Devices, Biomedical Engineering, V&V, Validation, FMEA, FDA, CAPA, Design of Experiments, Manufacturing..., Minitab, Solidworks, R&D, Root Cause Analysis, Injection Molding, Pro Engineer, ISO 14971
Education
University of California, Riverside 2004 — 2006
MS, Mechanical Engineering
Walla Walla University 2001 — 2004
BSE, Mechanical Engineering
Abbott Vascular May 2013 - Present
Abbott Vascular June 2011 - May 2013
Abbott Vascular October 2010 - June 2011
Abbott Vascular Devices April 2009 - October 2010
abbott December 2007 - March 2009
Skills
Six Sigma, CAPA, Continuous Improvement, Quality System, Lean Manufacturing, Process Excellence, Operational Excellence, DMAIC, Supply Chain Management, Demand Planning, Supply Chain, Supply Chain..., Medical Devices, Black Belt, Cross-functional Team..., GMP, Kaizen, Root Cause Analysis, Process Improvement, MRP, Product Development, Strategy
Education
The Open University 1999 — 2002
Master of Business Administration (MBA)
University of Limerick 1992 — 1996
Bachelor of Engineering (BEng), Mechanical Engineering
SageSpring Partners August 2010 - Present
Genentech December 2009 - August 2010
Abbott Vascular Devices August 2007 - December 2009
AlphaDetail 2003 - 2005
ERS Group 2002 - 2003
Arthur Andersen 2001 - 2002
Skills
Segmentation, Analytics, Market Research, Marketing Research, Market Analysis, Data Analysis, Competitive Analysis, Customer Insight, Strategy
Education
University of California, Berkeley - Walter A. Haas School of Business 2005 — 2007
Master of Business Administration (MBA)
University of California, Berkeley 1997 — 2001
BS, Economics
CoStar Group August 2015 - Present
Apartment Finder October 2010 - August 2015
Abbott Vascular Devices February 2008 - October 2010
Symantec September 2007 - January 2008
Symantec April 2006 - September 2007
Agilent Technologies June 2000 - April 2003
Transamerica March 1993 - June 1998
Skills
Strategic Planning, Sales Operations, Competitive Analysis, Forecasting, Web Analytics, Business Analytics, Mentoring, Microstrategy, Reporting & Analysis, Google Analytics, Business Planning, Process Improvement, Product Management, Budgeting, Territory, Financial Modeling, Negotiation, Contract Negotiation, Excel, PowerPoint, comScore, Business Intelligence..., Pricing, Omniture, Corporate FP&A, Social Media, Currency, Publishing, CRM, KPI Dashboards, KPI implementation, Vendor Management, Management, Employee Training, Project Management, Business Intelligence
Education
The University of Texas at Austin - The Red McCombs School of Business 1998 — 2000
MBA, Business
University of Massachusetts, Amherst 1986 — 1990
BA, Communications
Abaxis February 2012 - August 2012
Abbott Vascular Devices July 2010 - February 2012
Ford And Associates June 2009 - July 2010
Intuitive Surgical July 2008 - July 2009
Abbott Diabetes Care November 2004 - June 2008
R2 Technology June 2002 - September 2004
Philips June 2000 - May 2002
Olympus America January 1997 - January 2000
SGI February 1990 - April 1996
Skills
CAPA, ISO 13485, Medical Devices, FDA, Quality System, Quality Auditing, Sop, Quality Assurance, Supplier Quality, GxP, Cross-functional Team..., Auditing, Testing, Internal Audit, GMP, SOP, Validation, R&D
Education
Association of Clinical Research Professionals 2008 — 2008
Certification, Clinical Trial Auditing
American Society for Quality 2005 — 2005
Certification, Quality Syatems Auditing
San Jose State University 1990 — 1996
B.S., Industrial Technology?Management
West Valley College 1987 — 1990
S, Computer Electronics
Stryker Neurovascular January 2014 - Present
Hansen Medical, Inc. May 2012 - October 2013
Confidential Medical Company November 2010 - April 2012
MediTech Strategic Consultants BV September 2008 - September 2010
Satiety, Inc. March 2007 - September 2008
FoxHollow Technologies January 2006 - March 2007
Abbott Vascular Devices April 2005 - January 2006
Accuray, Inc. October 2003 - April 2005
Lumenis September 2002 - October 2003
RITA Medical Systems March 2001 - September 2002
Skills
Medical Devices, Clinical Trials, CRO, New Business Development, Clinical Research, Cardiology, Oncology, Lifesciences, Design Control, Regulatory Affairs, Hospitals, EDC, Clinical Development, Regulatory Submissions, Sop, Market Development, Biomedical Engineering, ISO 13485, CTMS
Education
San Francisco State University
BA, Clinical Science
Skyline College
Certificate, Respiratory Therapy
Boehringer Ingelheim July 2012 - August 2013
Onyx Pharmaceuticals May 2010 - March 2011
Medivation October 2009 - June 2010
Cerexa August 2008 - May 2009
Abbott Diabetes Care April 2007 - November 2007
Abbott Vascular Devices 2004 - 2006
Quintiles 2003 - 2004
Scios 2002 - 2003
Berlex Biosciences 2002 - 2002
Roche Bioscience 2001 - 2001
Skills
Clinical Trials, GCP, Data Management, Clinical Data Management, CRO, SAS, Validation, Oracle Clinical, SOP, Medical Devices, Diabetes, Document Management, Quality Assurance, Documentation, Access, Databases, Microsoft Office, Excel, Word, SQL, Sop, CRF design, Software Documentation
Education
University of California, Berkeley 1986 — 1991
Beverly Hills High School 1980 — 1984
Emerson Junior High 1978 — 1980
PMT Consulting Inc. March 2013 - Present
Masimo Corporation June 2012 - April 2013
Abbott Vascular Devices May 2006 - May 2012
Skills
Presentations, Public Speaking, E-Learning, SDLC, Configuration Management, Requirements Gathering, Medical Devices, PowerPoint, Visio, Microsoft Office, SharePoint, Quality Assurance, Troubleshooting, IT Management, Project Management, ERP, Program Management, Process Improvement, Requirements Analysis, Business Intelligence, Business Process, 21 CFR Part 11, Change Management, Microsoft Excel, Business Analysis, Technical Training, SAP, Cross-functional Team..., MS Project, Process Simulation, Process Engineering, Training, Management, Business Process..., Project Portfolio..., Analysis, Governance, PMP, Testing, Software Project..., IT Strategy, Microsoft Project, Leadership
Education
University of Arizona 1987 — 1991
Bachelor of Science, Civil and Environmental Engineering
Vanderbilt University 1984 — 1987
Environmental/Environmental Health Engineering
VertiFlex, Inc. November 2014 - Present
VertiFlex, Inc. September 2012 - November 2014
Medtronic Ablation Frontiers LLC August 2009 - September 2012
Ablation Frontiers September 2008 - August 2009
Abbott Vascular Devices March 2007 - September 2008
Applied Medical November 2006 - March 2007
Applied Medical February 2006 - November 2006
Skills
Solidworks Advanced User, Certificate in Project..., Design Control, ISO 13485, Medical Devices, R&D, FDA, Biomedical Engineering, V&V, Project Management, ISO 14971, Minitab, Catheters, Manufacturing, Design of Experiments, Product Development, CAPA, Validation, Quality System, Biomaterials, Design for Manufacturing, Solidworks, Root Cause Analysis, Engineering, Cross-functional Team..., SPC, Six Sigma, Product Launch, FMEA, GMP, Injection Molding, Commercialization, Regulatory Affairs, Lean Manufacturing, Medical Device R&D, Biotechnology, Manufacturing..., CE marking, Finite Element Analysis, Surgical Instruments, Process Simulation, 21 CFR, Supplier Quality
Education
University of California, San Diego 2000 — 2004
BS, Bioengineering (ABET)
Abbott Vascular Devices December 2008 - Present
BioForm Medical July 2008 - December 2008
Dexcom August 2007 - July 2008
Bionovo, Inc. September 2006 - June 2007
Education
University of California, Santa Barbara 2002 — 2006
B.S.
Parkview High School
Abbott Vascular Devices December 2009 - Present
Abbott Vascular Devices November 2008 - December 2009
Abbott Vascular June 2007 - November 2008
Peregrine Semiconductor October 2006 - May 2007
Magnecomp Corporation August 2005 - October 2006
Hewlett Packard Company June 1997 - August 2005
Motorola, Inc. July 1995 - June 1997
Davis & Geck, Inc. September 1994 - July 1995
Thermo King Corporation September 1992 - September 1994
Skills
Quality Engineering, Product Engineering, Production Management, Manufacturing, FMEA, Kaizen, 5S, SPC, Six Sigma, Continuous Improvement, Failure Analysis, Root Cause Analysis, Quality Systems, DMAIC, Minitab, CAPA, Maintenance Management, TPM, Kepner Tregoe, Project Facilitation, Kaizen Facilitation, Large Group Facilitation, Process Validation, Validations, Asset Management, Quality System, Project Management, Quality Control, FDA, Lean Manufacturing, Semiconductors, Medical Devices, Validation, ISO 13485, Manufacturing..., Cross-functional Team..., Quality Assurance, V&V, R&D, GMP, Design Control, Engineering Management, Change Control, Design for Manufacturing, Iso 9000, Process Simulation, Kepner-Tregoe, Quality Management, Production Managment, Operations Management
Education
University of Puerto Rico 1985 — 1992
BSIE, Industrial Engineering
Colegio Marista 1976 — 1985
High School Diploma
None August 2010 - Present
Caliber 2007 - 2010
Abbott Vascular Devices 2005 - 2007
WFHM 2003 - 2003
Bank of America 1990 - 2001
Education
University of California, San Diego
Certificate in Human Resources Management
Abbott Vascular Devices August 2013 - Present
Abbott Vascular Devices 2008 - August 2013
Covidien 2006 - 2008
Covidien (formerly Tyco Healthcare, Nellcor 2004 - 2006
Nellcor 2001 - 2004
Skills
Disposables, Medical Devices, Cath Lab, Market Development, Capital Equipment, Product Launch, FDA, Cardiology, Healthcare, Operating Room, Hospitals, Product Development, Surgeons, Urology, Management, Surgical Instruments, Sales Effectiveness, Sales Management..., Selling Skills, Sales
Education
The University of Kansas
B.S., Respiratory Therapy
Penumbra Inc June 2014 - Present
Medtronic Vascular August 2008 - Present
Abbott Vascular Devices July 2005 - August 2008
Abbott Vascular Devices December 2003 - July 2005
Bacchus Vascular May 2003 - December 2003
Medtronic Vascular 1999 - 2003
AngioDynamics August 1992 - August 1999
EZEM August 1990 - August 1992
Education
Texas Tech University 1986 — 1990
BBA, Marketing
Abiomed July 2014 - Present
Abiomed November 2012 - July 2014
Abiomed June 2010 - November 2012
MEDRAD Interventional / Possis September 2007 - June 2010
Endologix Inc March 2006 - August 2007
Abbott Vascular Devices November 2000 - March 2006
Skills
Cardiology, Sales Process, Field Training, Vascular, Medical Devices, Surgery, Cath Lab, Interventional..., Interventional Radiology, Capital Equipment, Cardiac, Surgeons, Consultative Selling, Hospitals, Negotiation, New Business Development, Territory, Market Development, Vascular Surgery, Contract Negotiation, Disposables, Healthcare, Selling, Account Management, Strategic Planning, Operating Room, Medical Sales, Stents, Catheters, Sales Rep Training, Surgical Device Sales, Capital Equipment Sales, Medical Imaging, Sales Effectiveness, Sales Force Development, Cardiac Surgery, Sales Management, Operating Room Sales, Sales Operations, Peripheral Vascular, Heart Failure, Endovascular, Territory..., Salesforce.com, Sales Leadership..., Medical Equipment, Building Relationships, Sales Presentations, Minimally Invasive..., Product Launch
Education
Santa Fe College 1996 — 1998
Associate's Degree, Cardiopulmonary Technology/Technologist
Edwards Lifesciences April 2013 - Present
Abbott Vascular Devices May 2009 - May 2011
AP Pharma 2007 - 2008
Skills
Clinical Monitoring, Medical Devices, FDA, Pharmaceutical Industry, Immunology, Clinical Trials
Education
UC Berkeley
Psychology
Independent Consultant October 2014 - Present
Brooks Life Science Systems November 2012 - 2014
Life Proof Cases November 2011 - October 2012
Abbott Vascular Devices July 2010 - September 2011
Accumetrics June 2008 - November 2008
Invitrogen 2007 - 2007
Hewlett Packard 1996 - 2007
IVAC Corporation February 1990 - July 1995
Baxter Healthcare Corporation, Technology & Ventures Division 1985 - 1990
IMED Corporation 1972 - 1981
Skills
Medical Devices, Cross-functional Team..., R&D, ISO 13485, FDA, Quality System, Injection Tooling, Injection Molding, Pharmaceutical Industry, Design for Manufacturing, Manufacturing, Systems Engineering, Lean Manufacturing, Start-ups, Validation, Product Development, SPC, GMP, Design Control, Quality Management, Outsourcing, FMEA, Failure Analysis, Biomedical Engineering, Contract Manufacturing, Solidworks, Biotechnology, Engineering Management, V&V, Product Management, Minitab, Product Design, Testing, Process Engineering, Leadership, Plastics, Six Sigma, Design of Experiments, Quality Assurance, Manufacturing..., CAPA, Technology Transfer, Engineering, Process Improvement, Strategy, Root Cause Analysis, Software Documentation, Manufacturing..., Electronics, Machine Tools
Education
University of California, Santa Barbara 1969 — 1972
Bachelors of Science, Mechanical Engineering, Pre-medical course studies
TE Connectivity Medical November 2012 - Present
Abbott Vascular February 2012 - November 2012
PK Clean June 2011 - February 2012
Abbott Vascular Devices November 2008 - May 2010
Hyde Engineering + Consulting January 2007 - November 2008
Baxter Bioscience November 2005 - December 2006
UMCP Department of Chemical and Biomolecular Engineering December 2003 - May 2005
Skills
Product Design, Product Development, Six Sigma, Equipment Design, Voice of the Customer, Polymers, Medical Devices, Catheters, Process Engineering, Process Scale Up, Design Verification..., Validation, CAPA, Biotechnology, GMP, Chemistry, Technical Anaylsis and..., V&V, Bioinformatics, Business Development, Chemical Engineering, Client Relations, Economic Modeling, Fermentation, Manufacturing..., Environmental..., Hazardous Waste..., Renewable Energy, Renewable Resources, Waste Management, Alternative Fuels, Waste To Energy, Water Chemistry
Education
University of California, Berkeley 2010 — 2011
MS, Environmental Engineering
University of Maryland College Park 2000 — 2005
B.S., Chemical Engineering
Ovesco Endoscopy USA In. June 2010 - Present
Yates Consulting March 2009 - June 2010
Sonoma Orthopedic Products October 2008 - February 2009
Sanarus Medical April 2007 - October 2007
CR Bard 2005 - 2007
Abbott Vascular Devices 2003 - 2005
Smith & Nephew Endoscopy 1999 - 2003
Boston Scientific 1984 - 1999
Ethicon 1982 - 1984
Skills
Strategic Planning, Market Research, New Business Development, Capital Equipment, Interventional..., Market Development, Marketing Strategy, Medical Devices, Surgical Instruments, Orthopedic, Product Launch, Sales
Education
University of Cincinnati College of Business 1975 — 1980
Bachelor of Business Administration (BBA), Marketing
Abbott March 2014 - Present
Abbott Vascular July 2012 - March 2014
Abbott Vascular October 2010 - July 2012
Abbott Vascular December 2007 - October 2010
Abbott Vascular Devices September 2003 - December 2007
Abbott Vascular Devices September 2001 - September 2003
Guidant August 2000 - August 2001
Guidant January 1999 - August 2000
Guidant June 1998 - January 1999
The Walt Disney Company May 1997 - August 1997
Skills
Medical Devices, Commercialization, Market Development, Cross-functional Team..., Product Launch, Competitive Analysis, Product Management, Global Marketing, Product Development, Product Marketing, Business Planning, Market Research, Start-ups, Biotechnology, Strategic Planning, Marketing Strategy, Brand Management, Marketing
Education
University of Southern California 1996 — 1998
MBA, Finance and Marketing
University of California, Berkeley 1990 — 1994
BA, Economics
CeloNova BioSciences, Inc. May 2012 - Present
CeloNova BioSciences, Inc. July 2011 - July 2012
Zimmer Dental November 2008 - July 2011
Abbott Vascular Devices February 2007 - October 2008
Skills
ISO 13485, Medical Devices, FDA, CAPA, Quality System, Validation, Cross-functional Team..., Design Control, Design of Experiments, FMEA, GMP, ISO 14971, R, Quality Assurance, Root Cause Analysis, V
Education
University of California, San Diego 2003 — 2006
Undergraduate, Bioengineering
Abbott Vascular Devices January 2009 - Present
NXP Semiconductors (formerly Philips Semiconductors) April 2005 - December 2008
Wells Fargo 2003 - 2005
OOCL 2001 - 2002
Aveo 1999 - 2000
APL 1998 - 1999
Skills
Content Management, Web Content Management, Marketing Communications, Project Management, Cross-functional Team..., Marketing, Marketing Strategy, Web Development, Visio, Customer Service, Product Marketing, CRM, Strategy, Graphic Design, Marketing Research, Product Management, Program Management, Vendor Management, Business Analysis, Document Management, Content Writing, SharePoint, CMS, Digital Marketing, Dreamweaver, Google Analytics, Mobile Applications, Mobile Marketing, Web Design, Marketing Automation
Education
San Francisco State University
MBA, Marketing
Nevro Corp April 2012 - Present
Abbott Vascular August 2011 - June 2012
Abbott Vascular Devices March 2009 - August 2011
AirXpanders, Inc July 2008 - March 2009
Allux Medical September 2006 - June 2008
Radiant Medical 2001 - 2006
Education
San Jose State University 1993 — 1997
Occupational Therapy
National Park Service February 2009 - Present
Abbott Vascular Devices June 2008 - February 2009
UNC Kenan-Flagler Business School August 2006 - May 2008
National Park Service June 2007 - August 2007
Hewlett-Packard March 2004 - May 2006
Hewlett-Packard April 2002 - March 2004
Hewlett-Packard July 2001 - April 2002
Skills
Excel, Financial Modeling, Essbase, Dreamweaver, Photoshop, Fireworks, Adobe Acrobat, InDesign, Illustrator, Data Analysis, PowerPoint, Financial Analysis, Word, Budgeting, Forecasting, Microsoft Office, Analysis, Outlook, Strategic Planning, Financial Reporting, Program Management, Business Analysis, Business Planning, Microsoft Excel, Cross-functional Team..., Strategy, Project Management, Training, Project Planning, Budgets, Microsoft Word
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2006 — 2008
MBA, Marketing and Sustainable Enterprise
San Jose State University 1996 — 2001
Bachelor of Science, Business/Finance, Minor in Humanities
Abbott Vascular January 2013 - Present
Abbott Vascular 2014 - 2015
Abbott Vascular 2014 - 2015
Abbott Vascular 2013 - 2014
Abbott Vascular 2013 - 2014
Abbott Vascular March 2012 - December 2013
Abbott Vascular August 2006 - March 2011
Las Madres 2005 Club 2006 - 2009
Abbott Vascular Devices 1999 - 2006
Skills
Process Improvement, SDLC, 21 CFR Part 11, Business Process, PMP, SAP, Management, Clinical Trials, Clinical Research, Business Analysis, Visio, Cross-functional Team..., Computer System..., SharePoint, Project Management, Governance, Training, Quality Assurance, Full SDLC, Leadership, Software Documentation, Databases, IT Management, IT Strategy, Business Intelligence, Project Portfolio..., Vendor Management
Education
University of California, Santa Cruz 2007 — 2007
Project Management Certification
San Jose State University 1985 — 1989
BA, Economics
Gilead Sciences January 2013 - Present
Gilead Sciences November 2011 - January 2013
Abbott Vascular Devices March 2008 - November 2011
Abbott Vascular Devices November 2005 - March 2008
Guidant Corporation (Acquired by Boston Scientific) November 2005 - April 2006
Confluent Surgical (Acquired by Tyco) June 2004 - August 2004
Skills
Medical Devices, Biomedical Engineering, Pharmaceutical Industry, R&D, CTMS, Validation, Cardiology, Cross-functional Team..., Data Analysis, Site Management, Vendor Management, CRO, ICH-GCP, Project Management, MS Project, EDC, Process Optimization, Clinical Trials, Clinical Development, FDA, Clinical Study Design
Education
The University of Texas at Arlington 2003 — 2005
Master of Science (MS), Bioengineering and Biomedical Engineering
The University of Texas Southwestern Medical Center at Dallas 2003 — 2005
Master of Science (MS), Bioengineering and Biomedical Engineering
University of Mumbai 1999 — 2003
Bachelor of Engineering (B.E.), Biomedical Engineering, First Class
ACADIA Pharmaceuticals Inc. September 2015 - Present
Human Longevity, Inc. March 2015 - August 2015
Bristol-Myers Squibb March 2013 - March 2015
BP Biofuels January 2012 - December 2012
Optimer Pharmaceuticals October 2010 - January 2012
CareFusion December 2007 - October 2010
Abbott Vascular Devices June 2006 - November 2007
On Assignment Lab Support September 2005 - May 2006
Cambridge Search July 2004 - July 2005
Joule Inc. October 2000 - October 2002
Skills
Recruiting, Human Resources, Sourcing, Talent Management, Onboarding, Talent Acquisition, FDA, Regulatory Affairs, Applicant Tracking..., Quality Control, Interviews, Screening, College Recruiting, Technical Recruiting, Management, Sales, Clinical Operations, Medical Affairs, Medical Devices, Employee Relations, Internet Recruiting, Hiring, Performance Management, Personnel Management, Employer Branding, Training, Deferred Compensation, Taleo, Temporary Placement, Workforce Planning
Education
Seton Hall University 1996 — 1998
BA, Communication Sciences
Abbott Sr HR Business PartnerHGST, a Western Digital companyAugust 2013 - August 2014
Abbott Vascular Devices February 2009 - July 2013
Codexis, Inc February 2007 - January 2009
Amgen June 2001 - September 2006
Cisco Systems November 2000 - April 2001
The Clorox Company August 1998 - November 2000
Lucent Technology (Octel Communications) 1995 - 1998
Sir Thomas Industrial Maintenance 1995 - 1995
Skills
Succession Planning, HRIS, Technical Recruiting, SAP HR, Talent Management, Organizational..., Employee Relations, Employee Handbooks, Employee Engagement, Employee Recognition, Employee Surveys, Compensation & Benefit, Medical Devices, Biotechnology Industry, Pharmaceutical Industry, High Tech, Start-ups, Enterprise Systems..., Taleo, Database Administration, Applicant Tracking..., Performance Management, Talent Acquisition, Pre-IPO, Telecommunications, HR Coaching, Leadership, Benefits Administration, Employee Benefits, Organizational..., Human Resources
Education
University of Scranton 2011 — 2014
MBA
University of California, Santa Cruz 2005 — 2006
Certificate with Honors - UC Santa Cruz Extension
San Jose State University
BS
Abbott Vascular February 2014 - Present
Department of Bioengineering, Santa Clara University January 2012 - Present
Abbott Vascular March 2012 - February 2014
Abbott Vascular Devices July 2008 - March 2012
Abbott Vascular April 2006 - July 2008
Guidant Corporation March 2006 - November 2006
Guidant Vascular Intervention January 2005 - March 2006
Guidant VI 2000 - December 2004
Skills
Diabetes, Interventional..., Clinical Development, Surgery, Medical Devices, Drug Eluting Stents, Biostatistics, Clinical Research, Pharmacology, R&D, FDA, In Vitro, Radiology, Biochemistry, ISO 13485, Biotechnology, Drug Delivery, Lifesciences, Biomedical Engineering, Cross-functional Team..., Clinical Trials, Commercialization, Pharmaceutical Industry, Validation, In Vivo, Life Sciences
Education
Santa Clara University
MBA, innovation and entrepreneurship
Southern Illinois University
M.S., Physiology
Southern Illinois University, Carbondale
Ph. D., Physiology
University of California, San Francisco
postdoc, Cardiovascular Research Instititute
Independent Consultant 2008 - Present
Velomedix 2010 - 2011
VNUS Medical Technologies (Covidien) 2006 - 2007
Abbott Vascular Devices 2004 - 2005
Conceptus (Bayer) 2000 - 2004
Embolx (BSC/Baxter) 1997 - 1999
Skills
Medical Devices, Clinical Development, Clinical Trials, Clinical Research, FDA, Regulatory Affairs, GCP, PMA, CTMS, Cardiology, Interventional..., Commercialization, IDE, Lifesciences, Biotechnology, Regulatory Submissions, Validation, CAPA, CE Mark, ISO Standards, Regulatory Strategy, Regulatory..., Design Control, FDA Audits, Biomedical Engineering, V&V, Nursing, Hospitals, Product Launch, Pharmaceutical Industry, Oncology, Cardiovascular Devices, Life Sciences
Education
University of California, Santa Cruz
Regulatory Affairs Certification
Golden Gate University
Westminster College
BSN, Nursing
University of California, Santa Cruz
Clinical & Medical Device Certification courses
Abbott Vascular November 2005 - Present
Abbott Laboratories 2005 - Present
Abbott Vascular Devices 2005 - Present
Abbott Vascular (Guidant) 2005 - Present
Maintenance Warehouse 2000 - 2005
Home Depot Supply 1995 - 2005
HD Supply 1995 - 2005
Skills
Unix, HP-UX, Storage Area Networks, Active Directory, Netbackup, Solaris, SAN, IBM AIX, AIX, Linux, VMware, HP
Education
San Diego State University-California State University 1983 — 1991
Bachelor of Science, Aerospace Structures
De La Salle High School 1979 — 1983
Genentech April 2010 - Present
Abbott Vascular Devices April 2009 - April 2010
Rigel Pharmaceuticals, Inc. September 2007 - February 2009
Roche Palo Alto LLC September 2005 - September 2007
University of Washington March 2004 - August 2005
Washington State University February 1999 - December 2000
Skills
Biotechnology, Molecular Biology, Lifesciences, Drug Discovery, Virology, Clinical Trials, Biochemistry, Cell Culture, Assay Development, ELISA, PCR, Immunology, Oncology, Western Blotting, Pharmaceutical Industry, Biomarkers, Microbiology, Cell Biology, Protein Purification, In Vitro, Clinical Research, Regulatory Affairs, Clinical Study Design, Regulatory Submissions, R, Science, Drug Development, Clinical Development
Education
University of California, Santa Cruz 2009 — 2010
Certificate, Clinical Trial Design and Management
The University of Georgia 2001 — 2003
Ph.D., Pharmaceutical and Biomedical Sciences
Louisiana State University and Agricultural and Mechanical College 1996 — 1998
M.S., Plant Pathology
China Agricultural University 1991 — 1995
B.S., Horticulture
Acclarent December 2006 - October 2010
Acclarent March 2005 - December 2006
Abbott Vascular Devices August 2003 - March 2005
Skills
Mergers & Acquisitions, Financings (VC,..., Treasury Management, Risk Management, Strategic Financial..., Financial Analysis, Accounting and Controls, Contract Negotiation, Long Range Planning, Recruiting & Retention, Training & Development, Performance Management, Compensation & Benefit, Employment Law, Compliance, Employee Relations, Financial Policies &..., Network Systems, IT systems development, IT System Deployment, QAD, Performance Dashboards, Business Strategy, Commission Plans, Sarbanes-Oxley, Investor Relations, Stock Plan..., KPI Dashboards, Physician Compliance, Sales Analysis, Internal Controls, Financial Modeling, HRIS, Deferred Compensation, Revenue Recognition, Revenue Forecasting, Cross-functional Team..., Medical Devices
Education
The Ohio State University Fisher College of Business 1996 — 2000
Life Technologies June 2009 - Present
Abbott Vascular Devices March 2008 - June 2009
GMAC ResCap 2003 - 2008
First American Corporation 2000 - 2002
San Diego County District Attorney's Office August 1998 - March 2000
Ford Motor Company, Geometric Results, Inc (wholly owned subsidiary) 1991 - 1998
Skills
Project Management, Cross-functional Team..., Leadership, Business Analysis, Software Project..., Requirements Gathering, E-commerce, SDLC, Software Development, Budgets, PMP, Strategic Planning, Program Management, Oracle Agile PLM, IT Service Management
Education
University of California, San Diego 1983 — 1990
Bachelor of Arts (BA), Linguistics
Essex Property Trust September 2014 - Present
Petersen Dean Inc. 2007 - 2009
Abbott Vascular 2006 - 2007
Abbott Vascular Devices 2005 - 2007
Skills
QuickBooks, Account Reconciliation, Accounts Payable, Accounting, Accounts Receivable, Microsoft Excel, Invoicing, Microsoft Word, Outlook, Microsoft Office, PowerPoint, Inventory Management, General Ledger, Financial Reporting, Forecasting, Financial Analysis, Peachtree, Cross-functional Team..., Bank Reconciliation, Inventory Reconciliation, Journal Entries, Management, Software Documentation, Purchasing
Education
San Jose State University 2010 — 2014
Bachelor's degree, Accounting, GPA: 3.8/4.0
Colegiul de Institutori 1999 — 2002
Associate of Arts and Sciences (AAS), Teaching English as a Second or Foreign Language/ESL Language Instructor
Roxwood Medical, Inc June 2014 - Present
Arstasis January 2011 - June 2014
Arstasis August 2007 - December 2010
FoxHollow Technologies, Inc. August 2004 - July 2007
Abbott Vascular Devices September 2001 - August 2004
Skills
Medical Devices, Quality Management, ISO 13485, FDA, V&V, CAPA, Design Control, Quality System, Regulatory Affairs, ISO 14971, GMP, Product Development, Change Control, Validation, Quality Assurance, Cross-functional Team...
Education
University of California, San Diego 1997 — 2001
BS, Bioengineering
Vivus Inc September 2008 - Present
Vivus Inc September 2008 - January 2011
Abbott Vascular Devices May 2006 - August 2008
Genentech July 2005 - April 2006
ICON Clinical Research January 2002 - July 2005
UC Davis Medical Center January 2000 - January 2002
Education
University of California, Davis 1994 — 1999
CareFusion July 2009 - Present
Cardinal Health May 2007 - September 2010
Abbott Vascular Devices May 2006 - May 2007
John H Harland October 1999 - March 2006
Education
Texas A&M University 1989 — 1994
B.S., Agricultural Development
Dignity Memorial Funeral Homes May 2015 - Present
Mercy Housing July 2008 - August 2012
Cepheid November 2007 - June 2008
Abbott Vascular Devices May 2006 - August 2007
VMware 2006 - 2006
Scios 2005 - 2005
Johnson & Johnson (Scios & Alza) 2005 - 2005
Skills
Leadership, Microsoft Word, Human Resources, Nonprofits, Team Building, Community Outreach, Microsoft Office, Strategic Planning, Customer Service, Leadership Development, Healthcare, Microsoft Excel, Management, Event Planning, Program Management, Public Speaking, Cross-functional Team..., Research, PowerPoint, Temporary Placement, Social Media, Training, Program Development, Community Development
Education
San Jose State University 1998 — 2000
BS, Health Science
Sanofi Pasteur July 2014 - Present
McNeil Consumer Healthcare May 2012 - July 2014
Johnson & Johnson May 2011 - April 2012
Revision Optics March 2011 - May 2011
St. Jude Medical March 2010 - March 2011
Abbott Vascular Devices April 2009 - December 2009
Amylin Pharmaceuticals December 2007 - March 2009
MDS Pharma Services February 2007 - September 2007
Zila, Inc. 2003 - 2007
Schein Pharmaceuticals 1994 - 2003
Skills
Compliance, Quality Systems, Validation, Change Control
Education
Université de Montréal 1983 — 1986
BS, Chemistry
College Stanislas
College Stanislas
Bridgepoint Education October 2013 - Present
Ericsson March 2013 - November 2013
Cricket Communications June 2009 - March 2013
Abbott Vascular Devices June 2004 - May 2009
Zzyzx Peripherals Inc February 1997 - June 2004
LG InfoComm December 1995 - February 1997
IntelliSoft December 1991 - December 1995
Compaq Computer September 1990 - October 1991
Skills
VMware ESX, VMware Infrastructure, Windows Server, Linux, Red Hat Linux, CentOS, HP-UX, AIX, SAN, System Administration, Operating Systems, SLES, Virtualization, Storage, Storage Area Networks, VMware, Routers, Cluster, System Deployment, vSphere, Data Center, Servers, Unix, Disaster Recovery, Troubleshooting, TCP/IP, Networking, Switches, RedHat, VMware vSphere, IBM AIX
Education
The University of Texas at Austin 1985 — 1990
Bachelor of Science (BS), Electrical and Electronics Engineering
PowerVision May 2012 - Present
Heal Medical, LLC October 2010 - Present
Abbott Vascular November 2011 - May 2012
Abbott Vascular Devices September 2009 - November 2011
Stanford University September 2008 - March 2009
Abbott Vascular Devices June 2008 - September 2008
Stanford University January 2008 - June 2008
Genentech June 2007 - August 2007
Iowa State University June 2006 - August 2006
Skills
Solidworks, Process Development, Prototyping, Design Thinking, Root Cause Analysis, Test Methodologies, DOE, Medical Devices, Machining, Illustrator, Prototype, Manufacturing, CAD, Design of Experiments, SolidWorks
Education
Stanford University 2008 — 2009
MS, Mechanical Engineering
Stanford University 2004 — 2008
BS, Biomechanical Engineering
Thermo Fisher Scientific January 2014 - Present
Quidel January 2012 - October 2013
Diagnostics for the Real World January 2010 - January 2012
Abbott Vascular Devices August 2009 - November 2009
Roche Palo Alto May 2006 - May 2009
University of Texas Medical Branch September 2001 - April 2006
Skills
Assay Development, Virology, Protein Chemistry, Infectious Diseases, Molecular Genetics, R&D, Biotechnology, Molecular Biology, ISO 13485, cGMP practices, Validation, ELISA, Cell Culture
Education
University of Hawaii at Manoa 1996 — 2001
Ph.D., Biomedical Sciences
University of Hawaii at Manoa 1993 — 1996
B.S., Microbiology
Abbott Vascular April 2013 - Present
Abbott Vascular January 2012 - April 2013
Abbott Vascular Devices January 2006 - December 2011
Abbott Vascular 2004 - 2006
Guidant Corp 1983 - 2004
Guidant 1983 - 2004
Guidant 1983 - 2004
IVAC Corp 1982 - 1992
Education
University of California, San Diego 1988 — 1992
Xilinx June 2012 - Present
Marvell December 2009 - August 2012
Marvell Semiconductor August 2005 - March 2009
Abbott Vascular Devices September 2006 - May 2007
Skills
FrameMaker
Education
Santa Clara University 2000 — 2004
B.S., Mechanical Engineering
UCSF March 2006 - June 2012
Amgen (Abgenix) February 2005 - February 2006
Abbott Vascular Devices February 2004 - January 2005
Skills
Biotechnology, Clinical Research, Immunology, Molecular Biology, Healthcare, Laboratory, Infectious Diseases, Biochemistry, ELISA
Education
University of California, San Francisco - School of Medicine
Thoratec Corporation May 2012 - Present
Abbott Vascular Devices 2007 - May 2012
Abbott Vascular 2008 - 2010
Abbott Vascular 2005 - 2007
Guidant Corporation 2001 - 2005
Skills
Sop, Clinical Development, Clinical Trials, GCP, Clinical Study Design, Medical Affairs, Regulatory Submissions, Protocol, Clinical Research, R&D, Medical Devices, FDA, Leadership, Regulatory Affairs, Lifesciences, Management
Education
University of Phoenix 2006 — 2009
MBA, Health Care Management
University of Cambridge 1998 — 2000
MPhil, Cardiovascular Clinical Pharmacology
GS Medical College and King Edward Memorial Hospital, Mumbai 1995 — 1998
MD, Clinical Pharmacology
Abbott July 2012 - Present
Abbott Vascular Devices May 2009 - July 2012
Pharmaceutical Services Corporation February 2008 - May 2009
Qiagen June 2007 - December 2007
Childrens hospital, Los Angeles January 2006 - June 2007
University of Southern California August 2005 - December 2005
UCLA Medical Center 2003 - 2005
UC San Diego April 2002 - December 2002
Skills
Validation, Project Management, Testing, Medical Devices, ISO 13485, Biotechnology, Biomedical Engineering, CAPA, FDA, Quality System, V&V, Design of Experiments, R&D, Cell Culture, Root Cause Analysis, Six Sigma, Design Control, Pharmaceutical Industry, Manufacturing, GMP, Process Improvement, Process Simulation, Change Control, GLP, ELISA, 21 CFR Part 11, Minitab, Sop, DMAIC, FMEA, SPC, Quality Assurance, Quality Control, Design for Manufacturing, Sterilization, GxP, GAMP, Regulatory Requirements, ISO 14971, Cleaning Validation, Computer System..., Aseptic Processing, FDA GMP, Product Launch, Western Blotting
Education
Texas A&M University
Master of Business Administration (MBA)
University of California, Irvine Extension
Certificate, Project Management
University of Southern California 2005 — 2007
MS, Medical Device and Diagnostic Engineering
University of California, San Diego
B.S, Bioengineering
Neodyne Biosciences, Inc February 2013 - Present
Vibrynt, Inc. February 2011 - December 2012
Vibrynt, Inc. March 2008 - January 2011
Abbott Vascular Devices February 2005 - March 2008
Abbott Vascular Devices March 2001 - February 2005
Skills
Medical Devices, Manufacturing..., Manufacturing, ISO 13485, CAPA, Design Control, Quality System, Validation, Root Cause Analysis, GMP, Solidworks, SPC
Education
University of California, Davis 1996 — 2000
Bachelor of Science (BS), Biological Systems Engineering
Abbott Vascular Devices July 2006 - Present
Vical, Inc June 2002 - July 2006
Skills
Quality System, FDA, Biotechnology, Validation, Quality Control, CAPA, GMP, ISO 13485, Medical Devices, Sop, 21 CFR Part 11, Microbiology, GLP, Change Control
Education
University of Rochester 1996 — 1998
Bachelor's Degree, Biological Sciences with a concentration in Microbiology
San Diego State University-California State University 2011 — 2012
Certificate, Regulatory Science
ReVision Optics September 2014 - Present
Covidien August 2012 - August 2014
St. Jude Medical October 2010 - May 2012
University of Washington December 2008 - September 2010
Allergan Inc May 2008 - September 2008
Biosensors International October 2007 - April 2008
Dr. Joyce Keyak September 2005 - September 2007
Abbott Vascular Devices 2007 - 2007
Skills
Process Validation, Technical Writing, Manufacturing, Research, Fast Learner, Catheters, Stents, Nitinol, FDA, Compliance, Innovator, Test Methodologies, Fluid Mechanics, Mechanical Testing, Medical Devices, Biomedical Engineering, Validation, Materials Science, Testing, Creative Problem Solving, Innovation, V&V, Quality System, Design of Experiments, Labview, Design Control, R&D, Minitab, Six Sigma, Biomechanics, Root Cause Analysis, Finite Element Analysis, Process Simulation, ISO 14971, Biomaterials, Solidworks, Design for Manufacturing, ISO 13485, Engineering, Mechanical Engineering
Education
University of California, Irvine 2014 — 2014
Certificate in Management for Technical Professionals, Biomedical/Medical Engineering
University of Washington 2008 — 2010
Masters, Material Science and Engineering
University of California, Irvine 2003 — 2008
BS, Biomedical Engineering, Material Science and Engineering
Pharmacyclics LLC (An AbbVie Company) July 2015 - Present
Pharmacyclics June 2012 - July 2015
Genentech November 2011 - June 2012
Cerexa Inc./ Forest Research Institute. June 2008 - September 2011
Abbott Vascular Devices March 2004 - June 2008
Skills
Clinical Trials, Pharmacovigilance, Clinical Development, Drug Safety, Clinical Research, GCP, Pharmaceutical Industry, Medical Writing, CTMS, Drug Development, EDC, Biotechnology, CRO, Clinical Monitoring, Oncology, Infectious Diseases, ICH-GCP, IND, Regulatory Submissions, Therapeutic Areas, Protocol, Clinical Data Management, Medical Affairs
Education
Stanford University School of Medicine
Post Doc at the Herzenberg Labs, Genetics and Immunology
University of London
Diploma, Sports Medicine
University of London
M.SC, Occupational /industrial medicine
University of Nigeria
MD, Medicine
Queens' College, Yaba Lagos Nigeria
Alveo Technologies November 2014 - Present
Self-Employed February 2014 - November 2014
Abbott Vascular July 2009 - February 2014
Abbott Vascular Devices April 2006 - July 2009
Refocus Imaging, Inc. now Lytro, Inc. October 2007 - March 2008
Guidant August 2004 - April 2006
Skills
Medical Devices, Technology Transfer, Manufacturing, Catheters, R&D, ISO 13485, Lifesciences, Biomedical Engineering, Clinical Trials, FDA, Testing, CAD, Design of Experiments, Product Development, Design Control
Education
Stanford University 2003 — 2004
MS, Mechanical Engineering
Stanford University 1999 — 2003
BS, Mechanical Engineering
Abbott Diagnostics July 2013 - Present
Abbott Diagnostics October 2011 - July 2013
Abbott Diagnostics October 2009 - September 2011
Abbott Vascular Devices September 2008 - November 2009
Abbott Vascular Devices December 2007 - September 2008
Abbott Vascular Devices February 2006 - December 2007
Skills
FDA, Medical Devices, Cross-functional Team..., Root Cause Analysis, Quality Assurance, GMP, Quality System, CAPA, Process Improvement, ISO 13485, Manufacturing
Education
Texas A&M University 2001 — 2005
Bachelor of Science, Biomedical Engineering
Texas A&M University 2001 — 2005
Bachelor of Science (B.S.), Biomedical Engineering
Abbott Vascular Devices December 2014 - Present
Abbott Vascular Devices September 2007 - Present
Abbott Vascular Devices January 1999 - September 2007
Skills
Medical Devices, Lean Manufacturing, Continuous Improvement, Cross-functional Team..., ISO 13485, ISO, R&D, Supply Chain Management, Manufacturing Operations, V&V, Supply Chain, Injection Molding, Process Engineering, Process Improvement, DMAIC
Education
University of California, Riverside 2005 — 2007
Navitus Medical LLC January 2015 - Present
Pathway Medical / Bayer Interventional / Boston Scientific Interventional November 2010 - Present
Synthes Spine January 2008 - November 2010
Abbott Vascular Devices January 2001 - January 2008
US Surgical October 1994 - May 2000
Hallmark Cards October 1990 - October 1994
Skills
Operating Room, Disposables, Cardiology, Sales Operations, Capital Equipment, Medical Sales, Surgeons, Medical Devices, Cath Lab, Market Development, Interventional..., Interventional Radiology
Education
The University of Kansas 1985 — 1990
American Medical Systems August 2012 - Present
Medtronic Spine & Biologics August 2010 - June 2012
Medtronic November 2009 - August 2010
Abbott Vascular Devices September 2007 - August 2009
Abbott Vascular Devices March 2006 - September 2007
Cygnus, Inc. April 2002 - April 2005
Johnson & Johnson 2000 - 2001
Johnson & Johnson 1996 - 2000
Education
Santa Barbara Community College
ADN and AA, Registered Nurse and Psychology
University of California, Santa Barbara
BA, Sociology
University of San Francisco
MPA, Masters of Public Administration, Health Services Administration
Abbott Vascular Devices May 2000 - Present
Abbott Vascular 2000 - Present
Skills
Cross-functional Team..., Medical Devices, Process Improvement, SAP, Analytics, Microsoft Excel, Management, Sales
Education
Sarah Lawrence College 1996 — 2000
Bachelor of Arts (B.A.)
CR Bard November 2012 - August 2015
Sorin Group December 2010 - May 2011
Covidien May 2010 - January 2011
Abbott Vascular Devices July 2006 - June 2008
GE Healthcare May 2005 - August 2005
GE Consumer and Industrial January 2005 - May 2005
Skills
R&D, Medical Devices, Design Control, Solidworks, FMEA, Design of Experiments, Lean Manufacturing, Manufacturing
Education
University of Colorado at Boulder 2009 — 2011
M.S., Mechanical Engineering, Bioengineering
University of Illinois at Urbana-Champaign 2002 — 2006
B.S., Mechanical Engineering
Abbott Vascular September 2011 - Present
Abbott Vascular May 2010 - September 2011
Abbott Vascular Devices December 2008 - May 2010
Abbott Vascular April 2007 - December 2008
Abbott Vascular April 2005 - April 2007
BP June 2004 - September 2004
Skills
Design Control, ISO 13485, Medical Devices, Design of Experiments, FDA, V&V, Validation, Quality System, Biomedical Engineering, Root Cause Analysis, R&D, FMEA, Lean Manufacturing, Process Engineering, Process Simulation
Education
University of California, Riverside 2008 — 2010
Master of Science (MS), Bioengineering and Biomedical Engineering
University of California, Los Angeles 2001 — 2005
Bachelor of Science (BS), Chemical Engineering
Intarcia Therapeutics, Inc. May 2015 - Present
Intarcia Therapeutics August 2014 - May 2015
Experien Group March 2013 - August 2014
Abbott Vascular Devices July 2007 - February 2013
Bio-Rad Laboratories July 2005 - June 2007
Lawrence Berkeley National Laboratory May 2004 - May 2005
UC Berkeley November 2003 - January 2005
Skills
Regulatory Affairs, Regulatory Submissions, Lifesciences, Biotechnology, Medical Devices, Molecular Biology, GMP, Clinical Trials, R&D, Sop, CAPA, Life Sciences
Education
Northeastern University 2008 — 2011
M.S., Regulatory Affairs
University of California, Berkeley 2003 — 2005
B.A., Molecular and Cell Biology
Abbott Vascular Devices February 2007 - Present
Education
University of California, San Diego
Abbott Vascular Devices Regional ManagerAbbott Vascular2005 - Present
Education
Slippery Rock University of Pennsylvania 1984 — 1988
Abbott Vascular Devices December 2006 - January 2014
Medtronic Vascular December 2005 - December 2006
ASI/Silica Machinery, LLC. October 1997 - June 2005
Skills
Medical Devices, GMP, SPC, Validation, CAPA, Manufacturing, Design Control, Manufacturing..., ISO 13485, Process Improvement, R&D, Root Cause Analysis, Product Development, Design of Experiments, Cross-functional Team...
Education
UCLA
B.S., Chemical Engineering, Cum Laude
Stanford University
Stanford Certified Project Manager, Project Management
Abbott Vascular Devices October 2007 - Present
ALZA Corporation 2006 - 2007
Skills
Biostatistics, Clinical Trials, Clinical Study Design, Clinical Development, CRO
Education
Simon Fraser University 2000 — 2006
Abbott Vascular Devices April 2013 - Present
Abbott Vascular Devices November 2012 - April 2013
Abbott Vascular Devices November 2007 - November 2012
Abbott Laboratories February 2005 - November 2007
Abbott / Guidant / Origin Medsystems July 2003 - February 2005
Guidant Corporation June 2001 - July 2003
Guidant Corporation May 1997 - June 2001
Skills
ISO 13485, Lean Manufacturing, Manufacturing, Medical Devices, Design Control, FDA, Engineering, Cross-functional Team..., Product Launch, Validation, Quality System, Product Development, Manufacturing..., CAPA, R&D, V&V, GMP
Education
San Jose State University 1993 — 1999
Masters of Science, Mechanical Engineering, 3.8
San Jose State University 1989 — 1993
Bachelor of Science (B.S.), Mechanical Engineering, 3.4
Abbott Diabetes Care July 2010 - Present
Abbott Diabetes Care July 2008 - June 2010
Abbott Vascular October 2006 - June 2008
Abbott Vascular February 2006 - October 2006
Abbott Vascular Devices February 2004 - February 2006
Skills
Sales Operations, Medical Devices, Cross-functional Team..., Product Launch, Pharmaceutical Industry, FDA, Pharmaceutical Sales, Diabetes, Project Management, Hospital Sales, Capital Equipment, Managed Care, Sales Force Development, Endocrinology, Market Development, Sales, Healthcare, Sales Management, Global Marketing
Education
San Francisco State University 2002 — 2004
BA, Speech & Communication
Abbott Laboratories 2008 - Present
Abbott Vascular Devices July 2008 - February 2012
ev3/FoxHollow Technologies October 2007 - June 2008
Foxhollow Technologies/Ev3 Inc. 2007 - 2008
Boston Scientific/Guidant- Cardiac Surgery Div. November 2004 - September 2007
Guidant Corp. 2000 - 2004
Guidant Corp. 1997 - 2000
Whitehall Robins Pharmaceuticals 1992 - 1997
Skills
Lean Manufacturing, Medical Devices, Manufacturing..., Process Validation, 5S, SPC, Kaizen, Continuous Improvement, CAPA, Manufacturing, GMP, ISO 13485, Quality System, V&V, FDA, Six Sigma
Education
Universidad Politécnica de Puerto Rico 1995 — 1997
MEM, Master in Engineering Management
Universidad de Puerto Rico 1980 — 1985
BSIE, Industrial Engineering
XenoPort December 2012 - Present
Abbott Vascular June 2012 - December 2012
Abbott Vascular January 2011 - May 2012
Abbott Vascular Devices April 2009 - December 2010
Abbott Vascular Devices May 2008 - April 2009
WWMR, Inc. July 2007 - April 2008
UC Davis May 2003 - July 2007
Skills
Clinical Product..., Product..., Data Mining/Analysis &..., Protocol Development &..., Trial Design &..., Clinical-Regulatory..., New Product Approvals, Clinical Presentations..., Key Opinion Leader..., Presentations, Clinical Research, Key Opinion Leaders, Protocol, Management, Electronic Submissions, Clinical Study Design, Manuscript, Product Development, Expansions, Product Lifecycle..., Medical Devices, Clinical Trials, Clinical Development, FDA, GCP, Neuroscience, Oncology, Biotechnology, Regulatory Affairs, Regulatory Submissions, Life Sciences
Education
University of California, Berkeley 1997 — 2003
PhD, Molecular and Cellular Biology
University of Virginia 1992 — 1997
Bachelor of Applied Science (B.A.Sc.), Biology
Eco Waste Conversion Solutions August 2012 - Present
Cambro Manufacturing October 2011 - October 2012
Angelica May 2009 - August 2010
CYP Realty February 2006 - February 2010
World Financial Group (WFG) 2008 - 2009
Abbott Vascular Devices 2006 - 2008
Vitroco, LLC July 2001 - July 2005
Gillette August 1996 - July 2000
Skills
Bilingual-Spanish, Spreadsheets, Six Sigma, Management
Education
United States Military Academy-West Point 1980 — 1984
BS, Engineering
United States Military Academy at West Point
Abbott Vascular Devices July 2007 - Present
Alza Pharmaceuticals August 2006 - July 2007
Scios July 2002 - August 2006
Skills
Analytical Chemistry, Biotechnology, Biopharmaceuticals, CAPA, Chromatography, Dissolution, Drug Development, Drug Discovery, FDA, FTIR, GLP, GMP, Gas Chromatography, HPLC, IND, IR, Laboratory, Lifesciences, Medical Devices, Method Development, Pharmaceutical Industry, Product Development, R, Quality Control, SOP, Science, Software Documentation, Technology Transfer, Sop, Training, Testing, Validation, cGMP practices
Education
San Jose State University 1998 — 2002
Chemistry, Concentration in Biochemistry
MediQuant Inc. July 2014 - Present
MediQuant Inc. June 2009 - July 2014
HWD Int'l Executive Search Partners January 2005 - June 2009
Sandstorm Diversified Holdings January 2003 - June 2008
Abbott Vascular Devices March 2003 - February 2006
Skills
Business Development, Healthcare Information..., Healthcare, Sales Management, Leadership, Sales, Medical Devices, Management, Strategy, Revenue Cycle Management, Executive Management, Sales Operations, Human Resources, Strategic Planning, Cross-functional Team..., Product Launch, Interventional..., General Surgery, Gynecologic Surgery, Process Improvement
Education
The Ohio State University
BSBA, Marketing
Abbott Vascular January 2015 - Present
Abbott Vascular April 2013 - January 2015
Abbott Vascular July 2011 - April 2013
Abbott Vascular January 2011 - July 2011
Abbott Laboratories July 2010 - December 2010
Abbott Vascular Devices January 2010 - July 2010
Abbott Laboratories June 2009 - December 2009
University of Illinois at Urbana-Champaign August 2008 - May 2009
Abbott Laboratories June 2008 - August 2008
Skills
Cross-functional Team..., Supply Chain, Process Improvement, SAP, Supply Chain Management, Strategic Planning, Continuous Improvement, Root Cause Analysis, Change Management, Business Process..., Business Analysis, Product Development, Manufacturing, Program Management
Education
University of Illinois at Urbana-Champaign 2005 — 2009
B.S., Chemical and Biomolecular Engineering
Abbott Vascular Devices May 2006 - March 2007
Guidant June 2004 - June 2006
SAM Technology July 1999 - September 2002
Skills
Competitive Intelligence, Medical Devices, Data Analysis, Market Research, Market Analysis, Cross-functional Team..., Segmentation, Product Launch, Strategy, Competitive Analysis, Strategic Planning, Product Development, Business Strategy, Product Marketing, Start-ups, Product Management, Analytics, Management, Marketing Strategy, Business Development, Project Management
Education
University of California, Berkeley, Haas School of Business 2002 — 2004
MBA, Marketing
University of California, Berkeley 2002 — 2003
MPH, Public Health/Health Care Administration
University of California, San Diego 1996 — 1999
BS, Psychology, summa cum laude
Abbott Vascular Devices March 2011 - Present
Abbott Vascular Devices August 2008 - March 2011
Abbott Vascular July 2006 - August 2008
Stanford University September 2005 - June 2006
Boston Scientific March 2005 - September 2005
Education
Stanford University 2004 — 2006
MS, Mechanical Engineering
University of California, Davis 2000 — 2004
BS, Mechanical Engineering
Abbott Vascular November 2011 - Present
Abbott Vascular Devices June 2009 - November 2011
Abbott Vascular April 2006 - May 2009
Guidant 2000 - 2006
Education
University of Wisconsin-Eau Claire 1974 — 1978
BSN, Nursing
UCLA Anderson School of Management
Ex Management, Executive Managment program
Foundry Newco XII June 2012 - Present
Private Consultatnt April 2011 - June 2012
Cabochon Aesthetics October 2008 - April 2011
Abbott Vascular Devices January 2006 - September 2008
Radiant Medical January 2004 - January 2006
Private Consultant Medical Devices August 2003 - January 2006
CardioVention November 1998 - August 2003
Baxter Cardiopulmonary Division October 1997 - November 1998
Heartport Corporation August 1996 - October 1997
Selectide 1993 - 1995
Education
University of Arizona 1990 — 1992
MS, Pharmacology/Perfusion Sciences
Weber State University 1973 — 1977
BS, Zoology
Stay at home mom May 2011 - Present
Abbott Vascular Devices January 2011 - May 2011
Abbott Vascular Devices July 2009 - January 2011
Abbott Vascular Devices July 2008 - July 2009
Stelex July 2001 - July 2008
Merck January 2000 - July 2001
Skills
V&V, Validation, FDA, GMP, ISO 13485, Change Control, CAPA, 21 CFR Part 11, Design Control, Sop, Quality System, Design of Experiments, Computer System..., Technology Transfer, Medical Devices, Pharmaceutical Industry, Quality Assurance, Cross-functional Team..., SOP, Management, Manufacturing
Education
Université Blaise Pascal (Clermont-II) - Clermont-Ferrand 1998 — 1999
DESS, Quality
Université Blaise Pascal (Clermont-II) - Clermont-Ferrand 1997 — 1998
Master, Physics, chemistry
Abbott October 2015 - Present
Abbott September 2013 - September 2015
Abbott Vascular Devices September 2011 - September 2013
Abbott Vascular September 2009 - September 2011
Abbott Vascular September 2006 - September 2009
Skills
Design Control, V&V, FDA, Quality System, CAPA, Medical Devices, Manufacturing, Lean Manufacturing, Product Development, Test Methodologies, R&D, Engineering, Validation, Design of Experiments, ISO 13485, GMP, Root Cause Analysis, Quality Assurance
Education
University of California, Riverside 2004 — 2006
Master of Science, Chemical Engineering
University of California, Riverside 2000 — 2004
Bachelor of Science, Chemical Engineering with a Biochemical Engineering focus
Abbott Vascular Devices September 2009 - Present
Boston Scientific September 2002 - August 2008
Boston Scientific September 1999 - September 2002
Medtronic November 1990 - May 1999
Viggo-Spectramed November 1987 - June 1990
Baxter Edwards Laboratories March 1985 - November 1987
Skills
CAPA, Catheters, Medical Devices, FDA, ISO 13485, Design Control, Quality System, V&V, Design of Experiments
Education
University of California, San Diego 1980 — 1984
BS, Applied Science (Bioengineering)
Intel Corporation August 2011 - Present
Samsung Electronics June 2010 - August 2011
Speech Processing and Auditory Perception Laboratory, UCLA January 2008 - June 2010
Abbott Diabetes Care June 2009 - August 2009
UCLA Electrical Engineering Department January 2009 - June 2009
Abbott Diabetes Care June 2008 - September 2008
Abbott Vascular Devices June 2007 - September 2007
Technical Management Program, UCLA Extension April 2007 - September 2007
Center for Embedded and Networked Sensing June 2006 - August 2006
Education
University of California, Los Angeles 2008 — 2010
M.S., Electrical Engineering - Signals and Systems
University of California, Los Angeles 2004 — 2008
B.S., Electrical Engineering specializing in Biomedical Engineering
Cisco February 2011 - Present
Abbott Vascular Devices November 2009 - May 2010
Tyco Electronics July 2006 - January 2009
Tyco Electronics April 2000 - June 2006
Skills
Business Analysis, SAP, Management, Data Analysis, Access, Microsoft Excel, Customer Service, Finance, Databases, Process Improvement, Salesforce.com
Education
Skyline College 1987 — 1992
A.A., Arts
Abbott July 2013 - Present
Abbott Vascular May 2012 - July 2013
Abbott Vascular March 2011 - May 2012
Abbott Vascular March 2008 - March 2011
Abbott Vascular Devices January 2007 - February 2008
zimmer September 2005 - December 2007
Western Digital March 2003 - September 2005
Western Digital December 2000 - March 2003
Parker Hannifin August 1998 - September 2000
Pixera June 1997 - September 1997
Skills
Design of Experiments, Solidworks, Manufacturing..., GD&T, SPC, FMEA, Design for Manufacturing, Design Control, Lean Manufacturing, Continuous Improvement, Equipment Qualification, R & D, Robotics, Automation, ISO 13485, Root Cause Analysis
Education
University of Southern California 2007 — 2011
MS, Mechanical Engineering
University of Arizona 1995 — 1999
BS, Mechanical Engineering
Abbott Vascular Devices August 2009 - Present
Abbott Vascular Devices September 2005 - August 2009
Skills
Medical Devices, ISO 13485, Biomedical Engineering, R&D, CAPA, Design Control, V&V, FDA, Drug Eluting Stents, Validation, Quality System, Coronary
Education
University of Florida 1994 — 1997
Master, Material Science and Engineering
Medela inc. May 2011 - Present
Cordis Endovascular January 2009 - May 2011
Spectranetics July 2007 - October 2008
Abbott Vascular Devices March 2006 - July 2007
Merit Medical Systems, Inc July 1997 - March 2006
Skills
Vascular, Interventional..., Cath Lab, Disposables, Sales Operations, Interventional Radiology, Strategic Consulting, Operating Room, Capital Equipment, Leadership, Surgeons, Market Development, Cardiology, Medical Devices, Vascular Surgery, Hospitals, carotid stenting, Account Management, Management, Product Development, Product Launch, Sales, Sales Force Development, Surgical Instruments, DME, Sales Management, Sales Process, New Business Development, Leadership Development, Process Improvement, Team Leadership, Cross-functional Team..., Teaching, Sales Enablement, Durable Medical..., NICU
Education
University of Dayton 1981 — 1985
BS, Marketing
Trimble Navigation August 2008 - Present
Abbott Vascular Devices March 1999 - May 2007
Skills
Tax, Sales Tax, Corporate Tax, Sarbanes-Oxley Act, Account Reconciliation, Auditing, Journal Entries, Accounting, Internal Controls, Analysis, US GAAP, Process Improvement
Education
San Jose State University 1979 — 1982
BS, Management
Thoratec September 2013 - Present
Johnson & Johnson January 2012 - August 2013
Abbott Vascular Devices April 2007 - January 2012
Medline Industries January 2006 - March 2007
Hospira May 2003 - December 2005
Abbott Laboratories November 1993 - May 2003
Abbott Laboratories 1993 - 2003
Abbott Laboratories-Hospital Products Division 1993 - 2003
Skills
Stents, Medical Devices, Catheters, Cardiac, Vascular, Disposables, Interventional..., Cardiac Surgery, CAPA, Interventional Radiology, Class I, Class II, class III, Infusion Pumps, FDA, Clinical Research, Cardiology, Neurology, Orthopedic, Clinical Trials, Cross-functional Team...
Education
University of Redlands 2010 — 2011
Master of Arts, Management
University of Illinois at Chicago College of Nursing 1978 — 1981
BSN, Nursing
University of Illinois at Urbana-Champaign 1977 — 1981
BSN, Nursing
AbbVie June 2015 - Present
AbbVie March 2014 - June 2015
AbbVie July 2010 - March 2014
Abbott Laboratories July 2008 - July 2010
Abbott Laboratories July 2006 - July 2008
Abbott Laboratories January 2008 - June 2008
Abbott Nutrition July 2007 - December 2007
Abbott Vascular Devices January 2007 - June 2007
Abbott Laboratories July 2006 - December 2006
Skills
V&V, Validation, CAPA
Education
Truman State University 2001 — 2006
B.S., Biology
CAY Clinical Consulting, LLC September 2013 - Present
Northwest Clinical Research Group, Inc. August 2011 - December 2013
Minerva Surgical June 2009 - July 2011
Pulmonx 2007 - 2009
Aptus Endosystems 2005 - 2007
Abbott Vascular Devices 2003 - 2005
Boston Scientific 2001 - 2003
Ethicon (Gynecare), Johnson & Johnson 1997 - 2000
Skills
Clinical Affairs, Medical Devices, Interventional..., PMA, Vascular, Vascular Surgery, Cath Lab, Capital Equipment, Surgery, Operating Room, FDA, CAPA, Clinical Trials, Cardiology, Neurology, EDC, Clinical Research, CRO, Clinical Data Management, Protocol, Medical Writing
Education
University of Alabama 1979 — 1983
BSN, Nursing
Abbott Vascular Devices 2008 - Present
Abbott Vascular 2003 - Present
Guidant 1996 - 2003
Quidel Corporation 1990 - 1996
Skills
PMA, Regulatory Strategy, Regulatory Affairs, 510 K, Regulatory Submissions, FDA, Regulatory Requirements, Medical Devices
Education
San Jose State University
Bachelor of Science, Business
Abbott Medical Optics December 2014 - Present
Los Angeles County Fire Department May 2003 - Present
Abbott Vascular February 2012 - December 2014
Abbott Vascular October 2010 - February 2012
Abbott Vascular March 2010 - October 2010
Abbott Vascular Devices August 2008 - March 2010
Abbott Vascular Devices June 2007 - August 2008
Abbott Vascular Devices October 2006 - June 2007
Skills
Root Cause Analysis, Specifications, Operations Management, Design of Experiments, Cpk, Medical Devices, Validation, Design Control, CAPA, ISO 13485, JMP, Negotiation, Mediation, Change Management, Project Management, Risk Management, Targeted Selection..., FDA, R&D, Lean Manufacturing, Manufacturing
Education
University of California, San Diego 2001 — 2005
B.S., Chemical Engineering
Abbott August 2014 - Present
Abbott Vascular Devices April 2013 - July 2014
Abbott Vascular Devices, Costa Rica December 2011 - March 2013
Abbott Vascular Devices, Costa Rica December 2010 - November 2011
Abbott Vascular Devices April 2010 - January 2011
Abbott Vascular Devices January 2008 - April 2010
Abbott Vascular Devices January 2006 - January 2008
Skills
ISO 13485, Design Control, Engineering, Medical Devices, Leadership, R&D, Design of Experiments, Project Engineering, CAPA, Manufacturing..., Validation, Process Engineering, Quality System, FDA, ISO, FDA GMP, Project Management, Design Engineering, ISO 14971, V&V, Mechanical Engineering, Nitinol, GMP, Stents, FMEA, Root Cause Analysis, Quality Assurance, Design for Manufacturing
Education
University of California, Los Angeles 2001 — 2005
B.S., Mechanical Engineering
Abbott Vascular Devices June 2009 - Present
Eli Lilly 2001 - 2008
Allergan 1999 - 2001
Baxter International Inc., CardioVascular Group (currently Edwards Lifesciences) 1997 - 1999
Skills
ICH-GCP, Clinical Research, Clinical Trials, FDA, Pharmaceutical Industry, GCP, Project Management, Medical Devices, Clinical Monitoring, Clinical Research..., Contract Negotiation, Budget Forecasts, Budget Process, Medical Writing, Clinical Development
Education
University of California, Los Angeles - Fielding School of Public Health 1994 — 1996
MPH, Epidemiology
University of California, Riverside 1990 — 1994
BS, Math and Biology
Abbott Vascular October 2012 - Present
Abbott Vascular Devices October 2009 - September 2012
Abbott Vascular 2007 - 2011
Education
University of California, Irvine 2010 — 2011
Certificate, Project Management
University of Phoenix 2001 — 2004
MBA, Technology Management
USNA 1974 — 1978
BS, Far Eastern Studies
QT Vascular Ltd. January 2015 - Present
TriReme Medical January 2009 - Present
Calypso Medical 2007 - 2008
Abbott Vascular Devices 2004 - 2007
Guidant 1994 - 2004
Skills
Medical Devices, Market Development, Product Launch, Capital Equipment, Deal Making, Sales Management, Commercialization, Surgeons, Vascular, Biotechnology, Sales Operations, ISO 13485, Urology, CAPA, Design Control, Strategy, Business Development, Cardiology, V&V, Global Marketing, Interventional..., R&D, Marketing, Operating Room, Product Marketing, Start-ups, Regulatory Affairs, Cross-functional Team..., Pharmaceutical Industry, Orthopedic, Sales Effectiveness, Oncology, Disposables, Clinical Trials, Neurology, Hospital Sales, Clinical Development, Pharmaceutical Sales, Medical Imaging, Biomedical Engineering, Surgery, Lifesciences, Hardware Diagnostics, Sales Force Development, Healthcare Industry, Life Sciences
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 1991 — 1993
MBA, general management
University of California, Berkeley 1982 — 1984
BA, English
Abbott Vascular Devices January 2009 - Present
Abbott Vascular Devices 2007 - 2008
Abbott Vascular Devices 2006 - 2007
Abbott Vascular Devices 2005 - 2006
Guidant 1997 - 2005
Skills
ISO 13485, Design Control, ISO 14971, CAPA, FDA, Regulatory Affairs, Medical Devices, V&V, GMP, Validation, Quality System, 21 CFR Part 11, Change Control
Education
San Diego State University-California State University 1987 — 1991
Bachelor of Science (B.S.), Business Administration and Management, General
South Western College 1982 — 1985
A.A., Pre-Business, emphasis Photo Journalism
Bonita Vista
Medtronic Vascular April 2012 - Present
Abbott Vascular Devices August 2008 - April 2012
Abbott Vascular Devices January 2007 - August 2008
Orthopeutics LP June 2006 - December 2006
USC Biomedical Engineering May 2004 - May 2006
Skills
Statistics, Process Validation, CAPA, Analytical Chemistry, Validation, Quality Systems, Stents, Regulatory Affairs, Design Control, Biomedical Engineering, DOE, Medical Devices, FMEA, Process Development, Design of Experiments, 510 K, GMP, ISO 13485, Medical Device Product..., JMP, Mechanical Testing, Drug Delivery, cGMP, Polymers, Manufacturing, Failure Analysis, Continuous Improvement, PMA, R&D, Catheters, ISO 14971, V&V, FDA, Minitab, Commercialization, Quality System, Biomaterials
Education
University of Southern California 2003 — 2006
MS, Biomedical Engineer
University of California, Davis 1999 — 2003
BS, Biological System Engineering
Sharp HealthCare May 2009 - Present
Alnitak, Incorporated August 2007 - Present
Abbott Vascular Devices January 2007 - December 2008
Ligand Pharmaceuticals February 2004 - January 2007
Countrywide August 2003 - February 2004
BD Biosciences November 2002 - April 2003
Sempra Energy August 2002 - November 2002
Faspac Systems June 2001 - March 2002
Cap Gemini Ernst & Young September 1998 - May 2001
Nationwide Financial August 1995 - September 1998
Skills
Microsoft SQL Server, Servers, SQL, ASP.NET, XML, Databases, C#, Integration, SDLC, .NET, Process Improvement, Oracle, PL/SQL, Software Development, VB.NET, Software Documentation, Data Warehousing
Education
Stanford University 2008 — 2008
Advanced Computer Security Certification
Franklin University 1992 — 1995
Bachelor of Science in Accounting
Abbott Vascular Devices May 2006 - Present
Alberta Research Council August 2000 - April 2006
Skills
Polymers, Injection Molding, FDA, Extrusion, Manufacturing, Materials, CAD, Medical Devices, Plastics, Biomaterials, Design Control, ISO 13485, Validation, Drug Delivery, Design of Experiments, R&D, Biomedical Engineering, DOE, cGMP, FMEA, Commercialization, GMP, CAPA, Product Development, Process Validation, Minitab, SPC, Quality Systems, Materials Science, Manufacturing Management, Solidworks, ISO, Manufacturing..., Process Development, Validations, Catheters, Medical Device Product..., Balloon material..., Pebax, Nylon, PET, Extrusion with the aid...
Education
University of Redlands 2007 — 2009
Master, MBA
Université Laval 1995 — 2000
Ph.D., Polymer materials and processing, rheology
Chengdu University of Science and Technology 1988 — 1991
Master, Polymer Materials and Engineering
Abbott 2012 - Present
Abbott Vascular 2008 - Present
Abbott Laboratories March 1998 - Present
Abbott Vascular (Abbott Vascular Devices) 1998 - Present
Abbott Vascular Devices 1998 - 2010
Skills
CTMS, FDA, Clinical Data Management, Medical Devices, Regulatory Affairs, Clinical Data, Clinical Trials, Clinical Research, CDISC, Validation, CAPA, Microsoft Excel, Sop, Cross-functional Team..., GCP, EDC, Clinical Development, 21 CFR Part 11, CRO, SOP, Pharmaceutical Industry, V&V
Education
University of California, Santa Cruz 2008 — 2010
CRA Certificate, Clinical
UCLA Anderson School of Management September 2006 - Present
Abbott Vascular Devices June 2008 - September 2008
Cerner LifeSciences June 2007 - September 2007
Covance July 2002 - July 2006
Education
UCLA Anderson School of Management 2006 — 2009
MBA, Marketing, Management
University of California, Los Angeles - Fielding School of Public Health 2006 — 2009
MPH, Health Services
University of Pennsylvania 1998 — 2002
BA, Economics, Biological Basis of Behavior
Abbott Medical Optics January 2013 - Present
Abbott Laboratories January 2011 - December 2012
Abbott Diagnostics May 2010 - August 2010
Abbott Vascular Devices June 2009 - December 2009
Skills
Biotechnology, R&D, V&V, Medical Devices
Education
University of California, Berkeley 2006 — 2010
Bachelor of Science, Bioengineering, Material Science and Engineering
Spirox, Inc. May 2015 - Present
D3DC April 2013 - May 2015
Acclarent September 2010 - March 2012
Acclarent November 2005 - September 2010
Abbott Vascular Devices March 2004 - November 2005
Skills
Medical Devices, Design Control, ISO 13485, FDA, R&D, V&V, Quality System, CAPA, Validation, Product Development, Biomedical Engineering, Design of Experiments, Solidworks
Education
Stanford University 1994 — 1997
Bachelor of Science (BS), Mechanical Engineering
Life Technologies 2008 - 2011
Abbott Vascular Devices 2007 - 2008
Education
University of California, Irvine
MS, Biomedical Engineering
University of California, San Diego
BS, Bioengineering
Gustavo Arroyo 1999 - 2013
Abbott Vascular Devices November 2006 - November 2009
CooperVision February 2005 - November 2006
ZYI Corporation February 2004 - December 2004
Products MAVER 1999 - 2003
Skills
Automation, Troubleshooting, PLC, Engineering, Validation, Manufacturing, R&D, Preventive Maintenance, Electricians, Project Management, Integration, Program Management, Six Sigma, Process Improvement, Testing, Medical Devices, Lean Manufacturing, Engineering Management
Education
Universidad de Guadalajara 1987 — 1992
Mechanical and Electrical Engineer
Terumo Medical Corporation February 2015 - Present
Boston Scientific August 2014 - December 2014
Bayer Interventional June 2010 - August 2014
Pathway Medical Technologies June 2011 - June 2013
Abbott Vascular Devices February 1999 - July 2011
Vantage Systems Designs, Inc. May 2000 - February 2001
Skills
Sales Process, Sales Management, Banking Operations, Medical Devices, Cardiology, Hospitals, Neurology, Consultative Selling, New Business Development, Cardiac, Selling, Negotiation, Surgeons, Account Management, Capital Equipment, Territory, Product Development, Strategic Planning, Interventional Radiology, Cath Lab, Customer Relations, Urology, Vascular Surgery, Forecasting, Business Planning, Contract Negotiation, Catheters, Mentoring, Cold Calling, Surgery, Financial Planning, Key Account Management, Healthcare, Market Development, Marketing Strategy, Microsoft Office, Business Strategy, Team Building, Budgeting, Retail, Problem Solving, Coaching, Product Management, Product Launch, Start-ups, Excel, Customer Service, Process Improvement, Direct Sales, Pharmaceutical Sales
Education
Texas Tech University 1978 — 1982
BBA, Real Estate / Finance
Trinity University
Finance
MarketVision Research, Inc June 2015 - Present
Investment Technology Group, Inc. March 2010 - Present
Investment Technology Group, Inc. February 2012 - May 2015
St. Jude Medical January 2006 - March 2010
Abbott Vascular Devices November 2005 - November 2006
Boston Scientific January 2003 - November 2005
Johnson & Johnson January 2000 - July 2003
Johnson & Johnson January 2000 - January 2003
Covidien (US Surgical) January 1997 - January 2000
DuPont Pharmaceuticals June 1999 - September 1999
Skills
Pharmaceutical Industry, Sales Operations, Cardiology, Medical Devices, Market Development, Account Management, Business Development, Sales Management, Sales, Healthcare, Product Development, Leadership, Selling Skills, Product Launch, Pharmaceutical Sales, Marketing, New Business Development, Hospitals
Education
University of Connecticut 1996 — 1999
Bachelor of Science
C.R. Bard September 2013 - Present
CR Bard January 2011 - September 2013
Abbott Vascular Devices 2008 - 2011
Boston Scientific January 2002 - March 2008
Skills
Capital Equipment, Medical Devices, Operating Room, Surgeons, Disposables, Interventional Radiology, Vascular Surgery, Interventional..., Cardiology, Cath Lab, Market Development, Surgical Instruments, Surgery, Vascular, Orthopedic, Product Launch, Selling, Sales Management, Sales Effectiveness
Education
University of Arkansas