Edwards Lifesciences
Industry: Medical device company
DescriptionEdwards Lifesciences is an American medical equipment company specializing in artificial heart valves and hemodynamic monitoring. It is mostly known for a transcatheter aortic heart valve made of bovine tissue within a collapsible stainless-steel stent, deployed via catheter. CEO: Michael A Mussallem (3 Apr 2000–) Headquarters: Irvine, California, United States Revenue: 3.4 billion USD (2017) Subsidiaries: Edwards Lifesciences LLC,
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Edwards Lifesciences Employees
Modern Health October 2014 - Present
ICU Medical December 2012 - October 2014
Pacific Life May 2009 - August 2012
ACS County of Orange October 2008 - May 2009
CSAA 2007 - 2008
Monarch HealthCare July 2006 - July 2007
Edwards Lifesciences 1999 - 2006
Beech Street/Healtheon April 1995 - December 1998
Syndicated Office Systems/Tenent March 1994 - April 1995
Skills
DHCP, XML, ASP.NET, HIPAA, Disaster Recovery, FDA, SOX Compliancy, Infrastructure, Project Management, VMware, Integration, ITIL, Storage Area Networks, Data Center, SAN, Software Documentation, IT Management, Active Directory, Information Technology, Vendor Management, Leadership, Servers, Management, Enterprise Architecture, Firewalls, Change Management, SharePoint, Network Security, IT Operations, Unix, Enterprise Software, Storage, System Deployment, Hardware, Citrix, Switches, Networking, ERP, Solaris, Outsourcing, Business Process, Help Desk Support
Education
National University 1985 — 1987
ASEE, Electronics Engineering
All-Star Executive Coaching
Codman Neuro - Johnson & Johnson July 2015 - Present
Edwards Lifesciences March 2013 - March 2015
Edwards Lifesciences September 2011 - March 2013
BioRobotics Laboratory, University of Tennessee Health Science Center January 2009 - September 2011
Molecular Imaging Laboratory, University of Tennessee Health Science Center August 2008 - January 2009
Smith & Nephew May 2008 - November 2008
Skills
Biomedical Engineering, Medical Devices, Manufacturing, ISO 13485, Design Control, FMEA, Design of Experiments, FDA, R&D, Minitab, Validation
Education
University of Tennessee-Health Science Center 2008 — 2011
Master of Science, Biomedical Engineering
Mississippi State University 2004 — 2008
Bachelor of Science, Biological Engineering
Chang Chun Plastics June 2015 - Present
Edwards Lifesciences February 2014 - December 2014
UC Irvine September 2012 - June 2013
National Taiwan University August 2011 - April 2012
Skills
IR spectroscopy, Gas Chromatography, Mass Spectrometry, UV/Vis, Organic Chemistry, NMR, NMR spectroscopy, Column Chromatography, Glove Box, Inorganic Chemistry, Viscometry, Karl Fisher, blood bench testing, polymer coating, R&D, Matlab, Chemistry
Education
University of California, Irvine 2012 — 2013
Master of Science (MS), Chemistry
National Taiwan University 2006 — 2010
Bachelor of Science (BS), Chemistry
Edwards Lifesciences July 2014 - Present
Edwards Lifesciences July 2012 - June 2014
Pathway Capital Management May 2011 - April 2012
Law offices of Higbee and Associates December 2010 - March 2011
Skills
JDE Enterprise One, Hyperion HFM, Microsoft Office, Midas, Finance, Analysis, Financial Analysis, Forecasting, Data Analysis, Financial Reporting, Business Valuation, Accounting, Microsoft Excel, Cost Accounting, Financial Modeling, Investments, Due Diligence, PowerPoint, Market Research, Research, Management, Strategic Financial..., Access, Research Analysis, Variance Analysis, JD Edwards, FX trading, FX Hedging, FX Derivatives, Bloomberg Terminal, QlikView
Education
University of California, Irvine - The Paul Merage School of Business 2010 — 2012
Bachelor of Science, Business Administration
Orange Coast College 2008 — 2010
Associate of Arts (AA), Liberal Arts
Nelson Headquarters April 2012 - Present
Edwards Lifesciences December 2008 - April 2012
Lehman Brothers 2005 - 2008
BNC Mortgage 2004 - 2005
Skills
PowerPoint, Microsoft Office, Microsoft Excel, Microsoft Word, Editing, Outlook, Visio, Spreadsheets, Event Planning
Education
Northern Arizona University
B.A., Liberal Studies, Zoology
Edwards Lifesciences December 2013 - Present
Johnson & Johnson July 2009 - December 2013
Ethicon Endo-Surgery March 2005 - 2009
Ethicon Endo-Surgery March 2003 - March 2005
LifeScan June 2000 - March 2003
LifeScan December 1998 - June 2000
BASF March 1993 - November 1998
Gabriel Ride Control January 1992 - March 1993
Hilti 1989 - 1990
Skills
Product Lifecycle..., Configuration Management, Quality Systems Design, Quality Management, Product Development, CAPA, Quality Control, Business Process, Requirements Management, Risk Management, Quality System, Medical Devices, V&V, GMP, ISO 13485, FDA, Software Quality..., Design Control, ISO 14971, Product Launch, Cross-functional Team..., Validation, Six Sigma, Management, Change Control, 21 CFR, Manufacturing, R&D, FMEA, Engineering, Design of Experiments, Quality Auditing, 21 CFR Part 11, Quality Assurance, Root Cause Analysis, DMAIC, ISO, CQA
Education
Oklahoma State University 1988 — 1991
BS, Mechanical Design Engineering Technology
Kerr Corporation February 2015 - Present
Edwards Lifesciences November 2013 - February 2015
Edwards Lifesciences March 2010 - November 2013
Edwards Lifesciences March 2008 - March 2010
Edwards Lifesciences April 2006 - March 2008
Baxter Healthcare September 2004 - April 2006
BECKMAN COULTER February 2000 - August 2004
Skills
Six Sigma, Design Control, Medical Devices, ISO 13485, Project Management, Validation, FDA, Quality System, V&V, CAPA, R&D, Product Launch, Packaging, Minitab, Manufacturing, Lean Manufacturing, Injection Molding, ISO 14971, Cross-functional Team..., Contract Manufacturing, Design of Experiments, FMEA, GMP, Commercialization, Packaging Engineering
Education
Michigan State University 1995 — 1999
BS, PACKAGING
Toledano LLC July 2013 - Present
Edwards Lifesciences April 2012 - August 2013
Edwards Lifesciences July 2008 - July 2012
Aspen Technology March 2007 - June 2008
Aspen Technology March 2006 - February 2007
Skills
Access, Business Intelligence, Salesforce.com, Sales Operations, Forecasting, Business Analysis, Salesforce.com..., Apex Programming, Visualforce Pages, Force.com, Salesforce.com..., JavaScript, SQL Server, QlikView, Visual Studio, MS Office Automation, VB.NET, C#, T-SQL, MySQL, IIS, ASP.NET AJAX, PHP, CSS, HTML, Excel, PowerPoint, VBA, Cognos, Business Objects, Hyperion, Sales Compensation, Sales Analytics, Forecast Modeling, Photoshop, Swimming, Oracle SQL, Oracle Financials, Microsoft Excel, Hyperion Enterprise, Business Process, ASP.NET, Microsoft SQL Server, CRM, Enterprise Software, SaaS, Visual Basic, Analysis, AJAX, Database Design
Education
Northeastern University 2000 — 2005
B.A., Philosophy
Cathedral Prep
St George Elementary School, Erie, PA
Electronic Arts (EA) April 2014 - Present
Edwards Lifesciences July 2012 - April 2014
Edwards Lifesciences July 2010 - June 2012
Associated Students UCI December 2009 - June 2010
California State Senate September 2009 - June 2010
UCI Department of Intercollegiate Athletics January 2007 - June 2010
Beachhouse.com January 2008 - September 2008
Education
University of California, Irvine 2006 — 2010
Bachelor of Arts, Economics, Accounting Minor, Dean's Honor List
Monash University
University of California Education Abroad Program
Medtronic December 2014 - Present
Austin Skeletal Trauma Specialists September 2012 - March 2013
Edwards Lifesciences April 2011 - September 2012
Edwards Lifesciences September 2009 - April 2011
Guidant 2003 - 2006
Guidant 2003 - 2006
Skills
Medical Devices, Market Development, Cardiology, Heart Valves, Hospitals, Cardiac Surgery, Critical Care, Medical Education, Product Launch, Healthcare, Surgery, Interventional..., Clinical Trials, Vascular, Surgeons, Cath Lab, Capital Equipment, ICU, General Surgery, Healthcare Industry, Neurology, Operating Room, Interventional Radiology, Vascular Surgery, Urology, Neurosurgery, Radiology, Disposables, Clinical Research, Medicine, Surgical Instruments, Medical Imaging, Internal Medicine, Hardware Diagnostics, Physicians, Spine, Oncology, Orthopedic, Pediatrics, Wound Care, Diabetes, Gastroenterology, Orthopedics
Education
Nova Southeastern University 1998 — 2000
BS, Physician Assistant
University of Florida 1995 — 1998
BS, Psychology
Edwards Lifesciences July 2015 - Present
Square November 2014 - March 2015
NutraGroup, Inc. September 2013 - August 2014
Terri's Berries July 2007 - August 2013
David Geffen School of Medicine February 2013 - June 2013
Hammer Museum December 2011 - July 2012
Macy's November 2009 - August 2011
Skills
Event Planning, Social Media, Microsoft Office, Volunteer Management, Higher Education, Customer Service, Community Development, Youth Mentoring, Data Entry, Public Speaking, Analysis, Purchasing Processes, Financial Analysis, Data Analysis, PowerPoint, Microsoft Word
Education
UCLA 2011 — 2013
Bachelor of Arts (B.A.), Anthropology
University of California, Center Rome 2012 — 2012
Roman Art, Italian History, Italian Language
Orange Coast College 2008 — 2011
General Education
Varian Medical Systems July 2015 - Present
Brax Health 2013 - Present
myoscience 2013 - 2015
Edwards Lifesciences 2012 - 2013
Abbott Vascular Structural Heart 2010 - 2012
Crescendo Bioscience 2009 - 2010
The Second City June 2009 - August 2009
Sadra Medical, a Boston Scientific company 2005 - 2007
Genomic Health 2004 - 2005
Corazon Technologies 2002 - 2003
Skills
Cross-functional Team..., Product Development, Product Launch, Management, Medical Devices, Biotechnology, Strategy, Marketing Strategy, Entrepreneurship, Competitive Analysis, Business Development, Marketing, Product Management, Market Research, Product Marketing, Market Analysis, Analytics, FDA, Leadership
Education
Northwestern University - Kellogg School of Management 2007 — 2009
MBA, Marketing, General Management, Entrepreneurship
Wolfson College, University of Oxford, UK 2000 — 2001
International Scholarship, Materials Science
Pomona College 1995 — 1999
BA, cum laude, Chemistry
Palo Alto High School 1991 — 1995
HS Diploma
Edwards Lifesciences September 2015 - Present
Cardiovascular Systems, Inc. May 2015 - September 2015
Abiomed January 2014 - May 2015
Abiomed March 2013 - January 2014
Philips Healthcare October 2012 - March 2013
St. Nicholas Hospital March 2011 - October 2012
Texas Health Resources October 2007 - March 2011
Skills
Radiology, PACS, EMR, Healthcare Information..., Healthcare, X-ray, Cath Lab, EHR, Vascular, Medical Imaging, Hospitals, Cardiology, Interventional..., EKG, ACLS, Inpatient, Computed Tomography, Epic Systems, Patient Education, Peripheral Vascular, Healthcare Industry, Capital Equipment, Medical Devices, Critical Care, Interventional Radiology, BLS
Education
Midwestern State University 2011 — 2012
BSRS, Radiologic Sciences
Mercy Medical Center 2004 — 2007
Radiology, Radiologic Technology/Science - Radiographer
University of Wisconsin-Oshkosh
Master of Business Administration (M.B.A.), Marketing
Terumo BCT December 2013 - Present
Baxter International Inc. May 2013 - December 2013
Edwards Lifesciences June 2011 - May 2013
Edwards Lifesciences June 2009 - June 2011
Edwards Lifesciences October 2007 - June 2009
Geneva Medical/ Taut, Inc April 2006 - September 2007
Skills
FDA, CAPA, Medical Devices, ISO 13485, Quality System, Quality Auditing, Complaint Management, Internal Audit, 21 CFR, Design Control, Regulatory Affairs, ISO 14971, Continuous Improvement, Regulatory Submissions, Software Documentation, Manufacturing, 21 CFR Part 11, ISO, Cross-functional Team..., Six Sigma, Quality Management, Management, Design of Experiments, DMAIC, Auditing, Capital Equipment, Supplier Quality, Clinical Trials, Testing, Biotechnology, Process Simulation, CRM, Lean Manufacturing, Biomedical Engineering, Technical Writing, Product Launch, Market Development, FMEA, CQA, Surgical Instruments, R&D, Lifesciences, Global Marketing, Value Stream Mapping, Product Development, Process Engineering, CE marking, SPC
Education
Westminster College 2010 — 2012
Gore School of Business- Master of Business Administration (MBA)
Northern Illinois University
Bachelor of Arts (B.A.), Psychology
Biomerics January 2015 - Present
Biomerics March 2014 - December 2014
Biomerics December 2013 - February 2014
Edwards Lifesciences April 2012 - November 2013
BD August 2011 - March 2012
BD October 2004 - July 2011
Skills
Operations Management, Six Sigma, Lean Manufacturing, Operating Budgets, Cost Reduction Solutions, Capital Budgeting, Black Belt, Extrusion, Performance Management, Goal Setting, Project Management, Mentoring, Process Improvement, Continuous Improvement, Cross-functional Team..., DMAIC, FDA, ISO 13485, Manufacturing, Medical Devices, Operational Excellence, Product Development, Quality System, Root Cause Analysis, Validation
Education
University of Utah 1992 — 1993
Master of Engineering (MEng), Mechanical Engineering
Michigan Technological University 1988 — 1992
Bachelor of Science (BS), Mechanical Engineering
Marketing Strategy Consultant July 2012 - July 2013
Uptake Medical March 2008 - July 2012
Edwards Lifesciences October 2003 - April 2008
VenPro Corp March 2000 - October 2003
American Red Cross - Tissue Services Division March 1998 - March 2000
Baxter Edwards CVS Division July 1987 - March 1998
Skills
Medical Devices, Marketing Strategy, Product Marketing, Product Development, Branding & Identity, Product Launch, Competitive Marketing..., Positioning, Mentoring, Market Analysis, Cardiac Surgery, Heart Valves, Interventional..., Pulmonology, Launch Strategies, Commercialization, Startup Marketing, Staff Development, Development &..., Target Market..., Global Business Planning, Strategy Execution, Product Management, Product Lifecycle..., Global Marketing, Cardiovascular Devices, Vascular Surgery, Competitive Analysis, Strategy, Cross-functional Team..., Capital Equipment, Surgeons, Start-ups, Market Development, Marketing, FDA, Cardiology, Design Control, Clinical Trials, Operating Room, ISO 13485, Disposables, R&D, Surgery, Business Planning, Surgical Instruments, Market Planning, Biomedical Engineering, Biotechnology
Education
Northwestern University - Kellogg School of Management
MBA, Marketing
University of California, Irvine
BS, Biological Sciences
Edwards Lifesciences April 2012 - Present
Bio-Rad Laboratories June 2009 - April 2012
Second Sight Medical Products January 2009 - April 2009
Terumo Heart, Inc. May 2008 - August 2008
Tandon July 2006 - April 2007
Skills
Regulatory Affairs, Biomedical Engineering, Clinical, FDA, Design Control, ISO 13485, CE marking, Medical Devices, CAPA, PMA, ISO 14971, Validation, V&V, Quality System, Clinical Trials, GMP, Regulatory Submissions, Regulatory Requirements, Clinical Research
Education
University of Southern California 2007 — 2009
Master of Science, Biomedical Engineering
Panjab University 2002 — 2006
B.S, Electronics & Communication
Edwards Lifesciences January 2007 - Present
Methodist Hospital of Southern 1972 - 2006
Skills
Market Development, Product Launch, Medical Devices, Disposables, Capital Equipment, Cardiology, Surgeons, Hemodynamic Monitoring, ICU, Clinical Research, Critical Care, Catheters, Cardiac Surgery, Anesthesia, Pediatrics, Hospitals, Operating Room
Education
Pasadena City College 1972 — 1974
Associate of Science (AS), Registered Nursing/Registered Nurse
Edwards Lifesciences September 2014 - Present
L-3 Communications January 2011 - Present
Nammo Talley, Inc. December 2007 - December 2010
STMicroelectronics September 2006 - December 2007
Skills
Manufacturing, Manufacturing..., Industrial Engineering, Lean Manufacturing, Management, Project Management, Mechanical Product..., Failure Modes & Effects..., AutoCAD, 8D Problem Solving, Capacity Management, Solid Edge, Minitab, ProModel, Microsoft Office, Modeling & Simulations, Robotics
Education
Industrial Engineering College
Bachelor of Science (B.S.), Industrial Engineering
Milwaukee School of Engineering
Engineering
Interventional Spine November 2006 - Present
3F Therapeutics August 2001 - September 2006
Medtronic August 1988 - July 2001
Allergan June 1983 - August 1988
Edwards Lifesciences October 1977 - June 1983
Skills
Spine, Medical Devices, Orthopedic, FDA, Start-ups, Surgery, Biomedical Engineering, Surgical Instruments, R&D, Neurosurgery, Healthcare, Clinical Research, Hospitals, Surgeons, Market Development, Mechanical Engineering, Commercialization, Product Launch, ISO 13485, Cardiology, Operating Room, Disposables, Cardiac Surgery, Heart Valves, Design Control, Global Marketing, Hardware Diagnostics, Sales Effectiveness, Medical Imaging, Clinical Trials, Venture Financing, Interventional..., Interventional Radiology, Neurology, Sales Force Development, IPO, Biotechnology, Cross-functional Team..., Start-up Ventures, Leadership, Business Strategy, Managing Start-ups, International Business, Executive Management, Orthopedics
Education
University of Puerto Rico, Mayaguez 1972 — 1977
Bachelor of Science (BS), Mechanical Engineering
National University 1981 — 1983
Master of Business Administration (MBA), Finance, General
Edwards Lifesciences July 2012 - Present
Weyerhaeuser March 2011 - May 2012
Weyerhaeuser March 2011 - July 2011
Weyerhaeuser October 2010 - March 2011
James M. Laws CPA December 2009 - May 2010
Skills
Microsoft Office, Microsoft Excel, Customer Service, SAP, Process Improvement, Microsoft Word, Variance Analysis, Transfer Pricing, International Tax, Corporate Tax, Accounting, Tax, Income Tax, Account Reconciliation, Financial Analysis
Education
Pacific Lutheran University 2005 — 2011
Bachelor of Business Administration (BBA), Accounting, Finance, and Human Resources
Sadra Medical, a Boston Scientific company 2014 - Present
Sadra Medical, a Boston Scientific company March 2012 - August 2014
Edwards Lifesciences June 2011 - March 2012
Edwards Lifesciences May 2009 - July 2011
Edwards Lifesciences January 2008 - May 2009
Edwards Lifesciences July 2006 - December 2007
Applied Biosystems June 2005 - September 2005
Skills
Medical Devices, Biomedical Engineering, FDA, Design Control, R&D, ISO 13485, Biomaterials, Quality System, Design of Experiments, CAPA, Minitab, V&V, Market Modeling, Commercialization, ISO 14971, Validation
Education
Northwestern University 2002 — 2006
BS, Biomedical Engineering
Edwards Lifesciences February 2015 - Present
Long Island Jewish Medical Center January 2010 - Present
Skills
Patient Safety, Inpatient, ICU, Healthcare Management, Clinical Research, General Surgery, Emergency Room, Operating Room, Nursing Education, Vascular, Patient Advocacy, Wound Care, Post Anesthesia Care, BCLS, IV, Physicians, Quality Patient Care, Infection Control, Nursing Process, Nursing Care, Emergency Medicine, Ambulatory Care, CPOE, Medical Terminology, JCAHO, Plastic Surgery, Reconstructive Surgery, Physician Relations, Emergency Nursing, Acute Care, Patient Education, Direct Patient Care, EKG, Registered Nurses, Vital Signs, EMR, Phlebotomy, Ambulatory, Cardiac Care, Trach Care, Cardiac Monitoring, Triage, Cpr Certified, PICC lines, Nursing Documentation, Pyxis, Medical/Surgical, Medication..., Surgery, Telemetry
Education
Molloy College 2006 — 2009
Bachelor of Science (BS), Registered Nursing/Registered Nurse, 3.7
Stony Brook University 2000 — 2001
Paramedic Program, Emergency Medical Technology/Technician (EMT Paramedic)
Edwards Lifesciences March 2011 - April 2013
Edwards Lifesciences July 2008 - March 2011
Edwards Lifesciences February 2008 - July 2008
Edwards Lifesciences February 2007 - February 2008
PIMCO September 2006 - February 2007
Newport West Funding January 2006 - September 2006
Eyestyles for Lifestyles June 2002 - January 2006
Skills
Medical Devices, R&D, Validation, FDA, ISO 13485, Design of Experiments, CAPA, Biomedical Engineering
Education
University of California, Irvine
Clinical Trials: Medical Device Development Certificate
University of California, Irvine
Medical Product Development Certificate
University of California, Irvine
Regulatory Affairs Management Certificate
University of California, Irvine 2004 — 2006
BA, Psychology
Orange Coast College 2001 — 2003
AA, Psychology
Christian Assembly January 2014 - 2015
Edwards Lifesciences February 2012 - November 2013
Neteon Technologies 2011 - 2012
Affinity Artists Agency 2011 - 2011
Gymboree 2006 - 2009
Skills
Leadership, Team Leadership, Microsoft Office, Microsoft Excel, Public Speaking, PowerPoint, Microsoft Word, Social Networking, Talent Management, Software Documentation, Visio, Training, Human Resources, Management
Education
Oklahoma State University 2003 — 2006
Theatre/Theater
Spectranetics January 2013 - Present
Edwards Lifesciences March 2005 - December 2012
Ethicon Endo-Surgery February 2000 - March 2005
Edwards Lifesciences - Endovascular Technolgies 2005 - 2005
Eaton Corporation October 1993 - February 2000
Skills
Medical Devices, Capital Equipment, Surgery, Cardiac Surgery, Cardiology, Surgeons, Surgical Instruments, Disposables, Urology, General Surgery, Orthopedic, Hospitals, Vascular, Cath Lab, Interventional..., Interventional Radiology, Market Development, Product Launch, Cardiothoracic Surgery, Minimally Invasive..., Stents, Surgical Device Sales, Operating Room Sales, ENT, Vascular Surgery, OB/GYN, Sales Operations, Cardiac
Education
Mississippi State University - College of Business and Industry 1988 — 1993
B.S. and B.B.A, Marketing and Industrial Technology
Various 2011 - Present
Edwards Lifesciences March 2009 - 2011
Amylin Pharmaceuticals 2006 - 2009
Arrow International 2004 - 2006
Smiths Medical 1999 - 2004
Sherwood, Davis, &Geck 1997 - 1999
Baxter Healthcare 1991 - 1996
Astra Pharmaceuticals 1987 - 1990
IMED Corporation 1983 - 1987
Abbott Labs 1980 - 1983
Education
Michigan State University 1975 — 1979
Packaging Engineering, Packaging
Seaholm HS 1971 — 1975
Vintage Audio Repair and Restoration May 2014 - Present
InterpreVision March 2009 - Present
Edwards Lifesciences December 2007 - January 2010
CardioVations 2005 - December 2007
Ethicon 2003 - 2005
Masimo Corporation 2002 - 2003
Edwards Lifesciences 2001 - 2002
Advanced Sterilization Products 1998 - 2000
Advanced Sterilization Products 1997 - 1998
Advanced Sterilization Products 1993 - 1996
Skills
Medical Devices, Product Launch, Strategy, Surgeons, Management, Market Development, Marketing Strategy, FDA, Product Development, Sales Operations, Marketing Communications, Product Management, Cross-functional Team..., Disposables, Clinical Research, Interventional..., Healthcare, Surgery, Market Research, Market Analysis, Operating Room, Capital Equipment, Cardiology, Neurosurgery, ISO 13485, Leadership, Surgical Instruments, Biotechnology, Strategic Planning, R&D, Orthopedic, Commercialization, Lifesciences, Start-ups, Six Sigma, Pharmaceutical Sales, Global Marketing, Marketing, Design Control, New Business Development, Pharmaceutical Industry, Biomedical Engineering, Urology, Hospitals, Sales Effectiveness, Spine, Cardiac Surgery, Vascular, Hardware Diagnostics, Neurology
Education
Pepperdine University 1987 — 1989
MBA, Business
Northern Illinois University
BS, Electronics Technology
ZT Systems October 2013 - Present
ZT Systems October 2012 - October 2013
Edwards Lifesciences August 2009 - October 2012
DENSO December 2007 - August 2008
Skills
Supply Chain Management, Logistics, Project Planning, Procurement, Inventory Management, Business Process, Process Improvement, Warehousing, Demand Forecasting, PowerPoint, Forecasting, Microsoft Excel, Demand Planning, Project Implementation, Business Analysis, Process Development, MS Project, CSCP, Demand Management, Warehousing Operations, Transportation..., Excel, QlikView, JD Edwards, Access, Data Mining, Financial Reporting, Oracle Agile, JDA, Reporting & Analysis, VBA, Visio, Microsoft SQL Server, SQL Server Management..., SQL, Supply Chain, Cross-functional Team..., Strategy
Education
Michigan State University 2004 — 2009
Applied Engineering Sciences/Supply Chain, Engineering, Supply Chain
Edwards Lifesciences July 2015 - Present
Integra LifeSciences May 2014 - June 2015
Integra LifeSciences July 2012 - June 2015
Integra LifeSciences September 2010 - June 2012
Biosoftmosis June 2007 - August 2007
Skills
Biotechnology, Product Development, Medical Devices, Biomedical Engineering, Chemistry, Analytical Chemistry, FDA, Start-ups, Manufacturing, Biomaterials, Design Control, Design of Experiments, ISO 13485, R&D, ISO 14971, Validation, Product Design, V&V, Tissue Engineering, CAPA, Commercialization, Cross-functional Team..., SOP, GMP, Microsoft Office
Education
New Jersey Institute of Technology 2009 — 2010
MS, Biomedical Engineering
New Jersey Institute of Technology 2004 — 2009
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Edwards Lifesciences March 2014 - Present
Amgen April 2011 - March 2014
IBM Global Services February 2008 - April 2011
Amgen September 2004 - February 2008
Norwest Vector Control May 2005 - June 2005
Jack Nadel International February 2002 - September 2004
ePolicy.com January 2000 - October 2000
Skills
Active Directory, Team Leadership, Windows, System Administration, DNS, Troubleshooting, DHCP, Identity Management, Servers, Disaster Recovery, Enterprise Software, VMware, Security, Infrastructure, ITIL, Vendor Management, Windows Server, Data Center, Visio, SharePoint, Virtualization, Cloud Computing, High Availability, Cluster, NetApp, System Deployment, SAN, IT Management, IT Operations, VMware ESX, Windows Architecture, System Architecture, Networking, Information Security, Software Installation, Microsoft Exchange, Information Technology, Testing, Architectures, Network Security, PKI
Education
Moorpark College 2008 — 2017
Bachelor's degree (In Progress), Computer and Information Sciences (In Progress)
Edwards Lifesciences June 2013 - Present
Abiomed July 2012 - December 2012
480 Biomedical/Arsenal Medical June 2011 - January 2012
Extracellular Matrix Engineering Research Laboratory January 2011 - January 2012
Codman & Shurtleff, Inc. July 2010 - January 2011
X-Ray Optical Systems, Inc. July 2007 - August 2009
Skills
PTC Pro/Engineer, Solidworks, SEM, Medical Devices, R&D, Engineering, Validation, Testing, Design of Experiments, V&V, Manufacturing, Pro Engineer, Lean Manufacturing, Finite Element Analysis, ANSYS
Education
Northeastern University 2008 — 2013
Bachelors of Science, Mechanical Engineering, Biomechanics
Aspen Medical Products February 2014 - Present
Abbott November 2013 - February 2014
Edwards Lifesciences March 2013 - November 2013
Applied Medical July 2011 - December 2012
New York University July 2008 - September 2010
Johnson & Johnson August 2006 - October 2007
Skills
Solidworks, SPC, Process Engineering, Process Validation, Advanced Materials, Composites, Supply Chain Management, Value Stream Mapping, SAP, Six Sigma, Lean Manufacturing, V&V, Minitab, Design of Experiments, Design for Manufacturing, FDA, Quality System, Manufacturing..., FMEA, R&D, Root Cause Analysis, SolidWorks
Education
New York University 2008 — 2010
MS, Material Science
University of California, Berkeley 2001 — 2005
BS, Bioengineering, Music
Edwards Lifesciences March 2014 - Present
Edwards Lifesciences April 2010 - February 2014
St. Jude Medical April 2005 - March 2010
ePartners March 2001 - March 2005
Cole Systems Associates, Inc. 1998 - 2001
McMaster-Carr September 1996 - February 1998
Education
Northwestern University 1992 — 1996
Maquet Cardiovascular April 2014 - Present
Cormatrix Cardiovascular August 2013 - April 2014
Covidien Respiratory and Patient Monitoring November 2010 - July 2013
Somanetics Corporation June 2007 - July 2010
Edwards Lifesciences June 1998 - October 2004
Skills
Medical Devices, Cardiac Surgery, Vascular, Cardiac, Surgery, Disposables, Operating Room, Clinical Research, Critical Care, Sales Operations, Surgeons, Cath Lab, Interventional Radiology, Capital Equipment, Cardiology, Interventional...
Education
Oakland University 1985 — 1998
BA, Communications and Journalism
Michigan State University
Communication, General
Edwards Lifesciences March 2014 - Present
Edwards Lifesciences March 2012 - Present
Beaumont Hospital August 2008 - March 2012
Body & Soul Wellness Center 1995 - 2001
Skills
Critical Care, Healthcare, Hospitals, Cardiology, Clinical Research, ICU, Nursing, Acute Care, Surgery, ACLS, Cardiac Surgery, BLS, Wellness, Operating Room, Pediatrics, Medical Devices, Enhanced Surgical..., Completed Fundamentals...
Education
Ohio University
Bachelor of Science (BS), Registered Nursing/Registered Nurse, currently 4.0
MCC
Associate of Arts and Sciences (A.A.S.), Nursing, 3.96
Edwards Lifesciences August 2012 - Present
Smith & Nephew November 2010 - August 2012
Boston Scientific January 2001 - November 2010
Education
Ohio University
BS, Education
Interface Catheter Solutions June 2012 - Present
Edwards Lifesciences March 2009 - March 2012
N/A February 2009 - March 2012
Guidant/Abbott Vascular April 2004 - January 2009
Boston Scientific December 1996 - February 2000
American Standard July 1992 - December 1996
HIMI CORPORATION April 1989 - April 1990
F.B.F. INDUSTRIES April 1986 - April 1989
Skills
Process Validation, FDA, Medical Devices, Validation, Quality Systems, Manufacturing..., R&D, SOP, Process Development, Quality System, V&V, Injection Molding, Process Simulation, CAPA, Sop, Design Control, Biomedical Engineering, Manufacturing, Design of Experiments, Testing, Design for Manufacturing
Education
UC Irvine 2008 — 2009
Certification Program, Medical Device Design and Development
Palomar College 2000 — 2001
N/A, AutoCad 2000
Pennsylvania Institute of Technology 1990 — 1992
Associates, Mechanical Engineering
Montgomery County Vocational Technical Institute 1987 — 1988
N/A, CNC Operating and Programming
Cleveland Clinic: Richards Jacobs Family Health Center January 2013 - Present
Southwest General Health Center November 2012 - January 2013
Huntington Beach Hospital (Prime Healthcare Corp) 2004 - 2012
I-Flow Corporation (Kimberly-Clarke Corp) February 2009 - February 2010
Edwards Lifesciences January 2005 - October 2007
Baxter Healthcare March 1995 - April 2000
Baxter Healthcare January 1992 - January 1994
Baxter Healthcare January 1991 - January 1992
Baxter Healthcare January 1989 - January 1991
Pfizer 1980 - 1988
Skills
Complaint Management, Brand Management, Medical Devices, FDA, Regulatory Affairs, ISO 13485, CAPA, Validation, Quality System, Design Control, Lifesciences, GMP
Education
National University 1982 — 1984
MBA, Marketing
Virginia Commonwealth University 1976 — 1979
MS, Medical Technology
University of Cincinnati 1969 — 1973
BS, Biology
CONTINUING EDUCATION (Seminars)
Edwards Lifesciences February 2006 - Present
CR Bard November 2001 - February 2006
Aerotek May 1998 - October 2001
Skills
Cardiology, Urology, Operating Room, Market Development, Surgeons, Medical Devices, Hospitals, Disposables, Surgical Instruments, Capital Equipment, Product Launch, Neurology, Orthopedic, Surgery
Education
Middle Tennessee State University
Bachelor of Business Administration (B.B.A.), Accounting, 3.5
TriReme Medical Senior Territory Manager, President's ClubAngioscore, Inc.June 2007 - November 2014
Edwards Lifesciences April 2005 - June 2007
Guidant ( Abbott Vascular) February 2002 - May 2004
Oracle May 1999 - February 2002
Cordis, Johnson & Johnson 1995 - 1998
Baxter Healthcare 1990 - 1995
Skills
Medical Device Implants, Enterprise Software, C-Level Business..., Start-ups, Business Development, CXO, Sales Operations, Sales, Medical Devices, Cardiology, Marketing Strategy, Vascular, Product Launch, Strategy, Disposables, Capital Equipment, Vascular Surgery, Market Development, Operating Room, Cath Lab, Surgeons, Interventional..., Interventional Radiology
Education
Sam Houston State University 1980 — 1983
BBA, General Business, Marketing
Midland College
business, marketing
University of Southern California - Coulter Translational Partnerhip February 2015 - Present
University of Southern California March 2004 - Present
JD Consulting February 1993 - Present
Edwards Lifesciences April 2011 - December 2014
St. Jude Medical July 2013 - December 2013
UC Irvine January 2006 - December 2013
St. Jude Medical May 2011 - March 2012
North Orange Coast Community College District January 2011 - March 2011
Rickett Benckiser (formerly SSL International, UK company) 2009 - 2009
Quantimetrix 2008 - 2009
Skills
Remediation, FDA, Quality System, Medical Devices, ISO 13485, Quality Assurance, Design Control, CAPA, Validation, Six Sigma, ISO 14971, Process Improvement, Root Cause Analysis, Lean Manufacturing, Product Development, Quality Control, Project Management, Problem Solving, Technology Transfer, Regulatory Affairs, Packaging, Lifesciences, Training, Biomedical Engineering, Design of Experiments, Quality Auditing, Quality Management, Quality systems &..., R&D, Packaging and..., ISO 11607, Supply Chain, Sterilization, Program Management, Start-ups, Compliance, Statistics, GMP
Education
Nova Southeastern University 1982 — 1983
MBA, Human Resource Management, 4.0
Osmania University
BS ChE, Cemical Engineering
University of Missouri-Columbia
MS ChE, 3.3
Intersect ENT November 2014 - Present
Edwards Lifesciences June 2014 - November 2014
Abbott Vascular June 2008 - May 2014
Abbott Vascular September 2009 - June 2012
Boston Scientific May 2005 - May 2008
Cardiology Associates of N MS January 2000 - May 2005
Skills
Clinical Monitoring, Project Management, Clinical Trials, GCP, EDC, ICH-GCP, Clinical Operations, Regulatory Submissions, Clinical Development, Sop, CRO, Clinical Research, CTMS, Interventional..., Protocol, Therapeutic Areas
Education
Mississippi University for Women 1989 — 1993
Bachelor of Science (BS), Registered Nursing/Registered Nurse
Hamilton High School 1984 — 1988
High School Diploma
Edwards Lifesciences September 2010 - Present
Fluor October 2005 - April 2010
Orange County Connectors 2010 - 2010
Fluor December 1994 - August 2009
Fluor August 1992 - December 1994
B. Braun Group August 1991 - July 1992
The Harter Group November 1989 - August 1991
Alcon Laboratories, Inc. December 1986 - November 1989
Skills
System Administration, Fundraising, Leadership, Program Management, Event Planning, Training, Public Relations, Internal Communications, Budgets, Recruiting, Customer Service, Newsletters, Cross-functional Team..., Project Management
Education
Orange Coast College 1986 — 1995
English
Boston Scientific February 2015 - Present
Amgen August 2013 - February 2014
Edwards Lifesciences May 2012 - June 2013
University of Southern California August 2011 - December 2012
Acumentrics Corporation June 2010 - May 2011
University of Connecticut September 2009 - May 2010
Victoria's Secret May 2007 - December 2008
West Virginia University June 2008 - August 2008
Skills
Labview, Matlab, Solidworks, Pro Engineer, Biomedical Engineering, Design of Experiments, R&D, Medical Devices, Engineering, Technical Writing, C++, Testing, Simulations, Finite Element Analysis, Materials, Materials Science, Chemical Engineering, Analysis, Mechanical Testing, C, Machining, Signal Processing, Minitab, Cross-functional Team..., Statistics, Simulink, Biomaterials, SolidWorks, LabVIEW, PTC Creo, Product Development, Microsoft Office
Education
University of Southern California 2011 — 2012
Master of Science, Biomedical Engineering
The University of Connecticut 2006 — 2010
Bachelor of Science, Biomedical Engineering
National University of Singapore 2009 — 2009
Spectranetics January 2012 - Present
Edwards Lifesciences February 2009 - January 2012
Ethicon, Inc. March 2008 - February 2009
Skills
Capital Equipment, Sales Operations, Medical Devices, Product Launch, Cath Lab, Cardiology, Market Development, Operating Room, Pharmaceutical Sales, Urology
Education
North Carolina State University
Bachelor of Science (BS), Food Science
University of Kentucky
Edwards Lifesciences August 2015 - Present
West-Ward Pharmaceuticals July 2014 - January 2015
Boehringer Ingelheim October 2011 - July 2014
Boehringer Ingelheim April 2010 - October 2011
Skills
Adobe Design Programs, Macintosh Applications, Communication Skills, Content Writing, Copy Editing, Project Management, Proofreading, Lectora, Microsoft Office, Team Leadership, Educational Leadership, Public Speaking, Acting, Technical Writing, Copywriting, Regulatory Affairs, Creative Writing, Training, Communication, FDA, Pharmaceutical Industry, SOP, Change Control
Education
Ohio University 2005 — 2009
Bachelor of Fine Arts (B.F.A.), English/Theatre Arts
Woodridge High School 2003 — 2005
High Honors Diploma
KISMET Information Systems and Services 2006 - Present
Edwards Lifesciences April 2003 - January 2012
The Upper Deck Company, LLC 2000 - 2003
JD Edwards 1999 - 2000
American Security Group 1997 - 1999
Volt Delta Resources 1990 - 1997
Skills
ERP, Integration, SOX, Requirements Analysis, Change Management, Process Engineering, SDLC, Disaster Recovery, JD Edwards, Business Process..., EDI, Software Documentation, Cloud Computing, IT Strategy, Project Management, Six Sigma, Sarbanes-Oxley Act, Oracle, Cross-functional Team..., Manufacturing, Management, MS Project, Program Management, Enterprise Software, Software Development, Business Process
Education
National University 1988 — 1989
MS, Software Engineering
Marmara University 1974 — 1978
BS, Business Administration
Edwards Lifesciences May 2014 - Present
3M October 2009 - May 2014
3M July 2008 - October 2009
Skills
Minitab, Design of Experiments, Six Sigma, Engineering, Process Improvement, Manufacturing..., DMAIC, Lean Manufacturing, FMEA, SPC, Value Stream Mapping, Root Cause Analysis, Kaizen, Solidworks, 5S, Continuous Improvement, Manufacturing, Product Development, Management, Process Engineering, Cross-functional Team..., Project Management, Quality System, Leadership, FDA, Medical Devices, Manufacturing...
Education
Oklahoma State University
BS, Mechanical Engineering
MKD Medical Devices, LLC November 2009 - Present
Saphena Medical Inc. September 2014 - Present
Edwards Lifesciences June 2013 - September 2014
AngioDynamics July 2012 - June 2013
Johnson & Johnson, Cordis Corp. October 2008 - November 2009
Johnson & Johnson, Cordis Corp. September 2006 - October 2008
Johnson & Johnson, Cordis Corp. April 2003 - September 2006
Guidant Corporation, Cardiac Surgery Group May 1994 - April 2003
Aesculap December 1992 - April 1994
Pitney Bowes, Dictaphone division April 1990 - November 1992
Skills
Medical Devices, Cardiology, Sales, Operating Room, Capital Equipment, Disposables, Hospitals, Healthcare, Interventional..., Cross-functional Team..., Surgery, Strategic Partnerships, Surgeons, Market Development, Product Launch, Product Development, B2B, Competitive Intelligence, Urology, Sales Operations, Vascular, Orthopedic, Sales Effectiveness, Surgical Instruments, Interventional Radiology, Neurosurgery, Commercialization, Neurology, Sales Force Development, Spine, Orthopedics
Education
New Milford High School 1979 — 1983
High School
Pace University-Pleasantville/Briarcliff Campus
BS, Economics
United Biologics May 2009 - January 2012
Edwards Lifesciences 1996 - 2007
LifeScan 2001 - 2006
Surgicose (johnson and Johnson) March 1981 - 1991
Hyland Labs (Baxter) 1986 - 1989
Baxter healthcare 1977 - 1986
Skills
Engineering, Contract Management, Construction, PowerPoint, Strategic Planning, Budgets, Process Automation, Business Development
Education
Northern Illinois University 1982 — 1984
MBA, management
Southern Illinois University, Carbondale 1968 — 1973
BSME, Mechanical Engineering
Southern Illinois University, Carbondale 1968 — 1973
BSME
Edwards Lifesciences June 2013 - Present
Rio Tinto May 2010 - June 2013
Rio Tinto January 2013 - April 2013
Mercury Marine June 2008 - December 2008
Skills
Metallurgy, Process Engineering, Mineral Processing, Materials Science, Engineering, Root Cause Analysis, Mining, Failure Analysis, Continuous Improvement, Process Control, Chemical Engineering, Project Engineering, Lean Manufacturing, Manufacturing, Materials, Six Sigma, Process Improvement
Education
Michigan Technological University 2007 — 2011
Bachelor of Engineering (BE), Materials Sciences
West Shore Community College 2005 — 2006
Direct Flow Medical®, Inc. November 2013 - September 2014
Corindus Vascular Robotics October 2012 - 2013
Edwards Lifesciences May 2011 - July 2012
Edwards Lifesciences January 2010 - January 2011
Edwards Lifesciences August 2008 - January 2010
Edwards Lifesciences January 2004 - August 2008
Percutaneous Valve Technologies (PVT) November 2003 - January 2004
NMT Medical January 2000 - November 2003
Angio-Seal 1998 - 2000
SCIMED 1994 - 1998
Skills
Surgery, Vascular, Hospitals, Healthcare, Market Development, Lifesciences, Vascular Surgery, Physician Training..., Interventional..., International..., structural heart, Heart Valves, transcatheter heart..., International Sales, domestic sales, Domestic Sales, Cardiac, Medical Education, Physicians, Medical Devices, Medical Imaging, Healthcare Industry, Training, Healthcare Information..., Heart Failure, Life Sciences, Product Launch, FDA, Cardiology, Capital Equipment
Education
Pepperdine University 2004 — 2006
incomplete, MBA
Ottawa University-Phoenix 1989 — 1991
Bachelor of Arts (BA), Health/Health Care Administration/Management
Yakima Valley Community College 1981 — 1983
Associate of Science (AS), Registered Nursing/Registered Nurse
Edwards Lifesciences March 2015 - Present
Kaiser Permanente July 2013 - March 2015
WellPoint 2012 - 2012
L.E.K. Consulting 2010 - 2011
L.E.K. Consulting 2008 - 2010
Kaiser Permanente 2007 - 2007
Empire Economics 2004 - 2006
Skills
Management Consulting, Strategy, Analytics, Strategic Consulting, Competitive Analysis, Financial Modeling, Market Entry, Business Strategy, Valuation, Corporate Development, Due Diligence, Corporate Finance, Market Analysis, Mergers & Acquisitions, Healthcare, Business Development
Education
Kellogg Graduate School of Management 2011 — 2013
Master of Business Administration (M.B.A.), Finance, Health Enterprise Management, Management and Strategy, and Social Enterprise
University of California, Berkeley 2004 — 2008
Bachelors of Science, Business Administration and Management, General
St. Margaret's
St. Margaret's
Restoration Robotics January 2013 - Present
Principal August 2011 - December 2013
Boston Scientific April 2009 - May 2011
Covidien December 2007 - January 2009
Medtronic December 2004 - December 2007
Medtronic November 2003 - December 2004
Medtronic May 1999 - December 2003
Cyberonics June 1997 - December 1999
Boston Scientific 1990 - 1997
Edwards Lifesciences March 1988 - August 1990
Skills
Forecasting, Product Launch, Cross-functional Team..., Market Development, Operating Room, Leadership, Cardiology, Six Sigma, Sales, B2B, Capital Equipment, Disposables, Sales Effectiveness, Selling, Surgeons, Cath Lab, Medical Devices, Business Development, Surgical Instruments, Sales Management, Interventional..., Selling Skills, Management, Vascular, Sales Force Development, Sales Operations, Interventional Radiology, Neurosurgery, Urology, Commercialization, Pharmaceutical Sales, Orthopedic, Medical Sales, Gastroenterology, Neurology, Orthopedics
Education
Rockhurst University 1988 — 1992
MBA, Marketing/Finance
Central Missouri State University
BSBA, Marketing / Management
Northwestern University
MS, Healthcare Informatics
Edwards Lifesciences October 2011 - Present
Epocal/ Alere 2008 - 2011
Hill-Rom July 2007 - July 2008
Schering Plough/Millenium Pharmaceuticals/Cor Therapeutics 1998 - 2007
Abbott June 1991 - December 1998
Skills
Hospitals, Medical Devices, Critical Care, Cardiology, Consultative Selling, Healthcare, Territory, Surgery, Sales Force..., Cross-functional Team..., Sales Operations, Capital Equipment, Sales Effectiveness, Selling, Operating Room, Disposables, Surgeons, Market Development, Product Launch, Pharmaceutical Sales, Urology, Neurology, Cath Lab, Pharmaceutical Industry, Biotechnology
Education
Notre Dame College
Bachelors, Marketing
AT&T August 2008 - Present
The Walt Disney Company January 1999 - January 2000
Edwards Lifesciences April 1994 - December 1999
Skills
VoIP, LAN-WAN, Cisco Technologies, Routers, Switches, Network Design, Network Architecture, Project Management, Telecommunications, Cisco IOS, IP, Routing, System Administration, Ethernet, Network Engineering, Visio, IT Operations, DSL, Troubleshooting, Vendor Management, Disaster Recovery, Mobile Devices, Wireless, Cisco Routers, TCP/IP, Unified Communications, Network Administration, DNS, Managed Services, WAN, Telephony, Unix, OSPF, Cisco Nexus, Integration, CCNA, EIGRP, Security, Frame Relay, Network Security, DHCP, Service Delivery, Wireless Networking, Linux, IPv6, ATM networks, Data Center, PMP, Networking, Virtualization
Education
National University 1986 — 1990
Business Administration
Hempfield 1973 — 1977
High School/Secondary Diplomas and Certificates
Edwards Lifesciences February 2014 - Present
Natvar March 2012 - November 2013
FlexMedical October 2010 - 2012
Medtronic January 2006 - October 2010
Accellent March 2003 - November 2006
Skills
Medical Devices, Product Development, ISO 13485, Design Control, FDA, CAPA, Quality System, Design of Experiments, Biomedical Engineering, FMEA, R&D, V&V, Testing, Manufacturing, Design for Manufacturing, Injection Molding, DMAIC, Continuous Improvement, Six Sigma, Manufacturing...
Education
New Mexico State University 1988 — 1992
Mechanical Engineering
Medtronic March 2014 - Present
Urologix August 2010 - Present
Kimberly-Clark May 2011 - January 2014
US HIFU November 2010 - April 2011
FlowCardia Inc. July 2009 - October 2010
FlowCardia, Inc November 2007 - July 2009
Edwards Lifesciences April 2005 - November 2007
Cordis Cardiology June 1999 - April 2005
Schneider Worldwide 1997 - 1999
Schneider Worldwide 1995 - 1997
Skills
Market Development, Operations Management, Leadership, Medical Devices, Operating Room, Sales Effectiveness, Sales Management, Product Launch, Cardiology, Strategy, Surgery, Contract Negotiation, Sales, Capital Equipment, Direct Sales, Sales Operations, Cross-functional Team..., Product Development, Surgeons, Management, FDA, Surgical Instruments, Orthopedic, Disposables, Business Development, Start-ups, Commercialization, Urology, Marketing, Orthopedics
Education
Northern Illinois University 1984 — 1989
Marketing
Merit Medical Systems, Inc. January 2015 - Present
Edwards Lifesciences November 2013 - December 2014
Edwards Lifesciences March 2012 - October 2013
Edwards Lifesciences January 2009 - July 2012
ZARS Pharma 2006 - October 2008
Northwest Research, Inc. 2003 - 2005
Skills
Regulatory Affairs, Medical Devices, Medical Writing, Regulatory Submissions, Design Control, Quality System, FDA, GMP
Education
Northeastern University 2011 — 2013
Masters of Science, Regulatory Affairs for Drugs, Biologics, and Medical Devices
Weber State University 2001 — 2007
Bachelor's, English with Technical Writing Emphasis - French
Edwards Lifesciences June 2014 - Present
Abbott Vascular December 2007 - May 2014
ICON Interventional January 2004 - December 2007
NeuroControl May 2000 - May 2003
MicroVena May 1996 - June 2000
Heart Technology 1992 - 1996
Skills
Medical Devices, Interventional..., Capital Equipment, Cardiology, Clinical Research, Healthcare, Hospitals, Operating Room, Product Launch, Sales Effectiveness, Surgeons, Urology, Disposables, Interventional Radiology
Education
Ohio Northern University 1979 — 1982
Edwards Lifesciences September 2012 - Present
PotentiaMED 2010 - 2014
Sorin Group September 2009 - September 2012
Intuitive Surgical 2007 - 2010
AtriCure, Inc. January 2005 - February 2007
Somanetics Corporation December 2001 - February 2004
Skills
Surgeons, Cardiology, Medical Devices, Cardiac, Surgery, Sales Management, Disposables, Thoracic, Capital Equipment, Cardiac Surgery, Vascular, Cath Lab, Consultative Selling, Hospitals, Operating Room, Interventional..., Market Development, Neurology, Urology, Robotic Surgery, Surgical Instruments, Sales, General Surgery, Neurosurgery, Interventional Radiology, Orthopedic, Medical Sales, Product Launch, Capital Equipment Sales
Education
Missouri State University
Bachelor, Marketing
Edwards Lifesciences May 2014 - Present
GE Healthcare July 2010 - May 2014
GE Healthcare May 2007 - July 2010
Abbott Laboratories 1990 - 2005
Skills
spanish, ISO 9001:2008, ISO 13485:2003, Complaint Management, CQE, Supplier Quality, CAPA, External Audit, Supplier Auditing, Management Review, FDA GMP, ISO 13485, 21 CFR Part 11, Auditing, CE marking, DMAIC, Design for Manufacturing, Design of Experiments, FDA, Iso 9000, Medical Devices, Quality Assurance, Quality Auditing, Quality Control, Quality Management, Quality System, Spanish, Supplier Evaluation, Supply Chain, V, Validation, 21 CFR, Design Control, FMEA, ISO 14971, Minitab, Six Sigma
Education
Michigan State University 1979 — 1984
BS, Packaging
Gerson Lehrman Group, Inc September 2015 - Present
L.E.K. Consulting May 2015 - Present
Kennedy Consulting April 2010 - Present
Ivantis, Inc August 2008 - April 2010
Edwards Lifesciences June 2007 - July 2008
Johnson and Johnson January 2001 - May 2007
Kennedy Consultants, LLC July 1998 - December 2002
Chiron Corporation June 1996 - July 1998
IBRD Rostrum Global April 1994 - May 1996
Skills
Clinical Trials, Clinical Development, GCP, CRO, Biotechnology, Medical Devices, Regulatory Submissions, Biosimilars, Clinical Research, 505(b)(2), Infectious Diseases, Oncology, EDC, Oncology Clinical..., Pharmaceutical Industry, Clinical Monitoring, Drug Development, Regulatory Requirements, Protocol, Biopharmaceuticals, CTMS, FDA, 21 CFR Part 11, Clinical Operations, Cardiology, Mentoring Of Staff, Hemodynamic Monitoring, CAPA, Vaccines, Clinical Data Management, Entrepreneurship, Medical Writing, Diabetes, SOP, Pain Management, Pharmacovigilance, Class III Medical..., Commercialization, Ophthalmology, Continuous Glucose..., Life Sciences, Therapeutic Areas, Management, Leadership
Education
Sonoma State University 1989 — 1993
B.A., Biology
Orange Coast College
Associate of Arts (A.A.), Business Administration and Management, General
Sonoma State University
Bachelor's degree, Bacteriology - Graduate Course, A
Edwards Lifesciences June 2015 - Present
Henry Crowne Sports Pavilion October 2013 - October 2014
Skills
Biomedical Engineering, Matlab, Cell Biology, Solidworks, Microsoft Excel, SolidWorks, PowerPoint, Public Speaking, Research
Education
Northwestern University 2012 — 2016
Bachelor of Science (BS), Bioengineering and Biomedical Engineering
Edwards Lifesciences March 2012 - Present
Deloitte & Touche September 2010 - February 2012
KPMG Advisory January 2006 - September 2010
Bristol Myers Squibb 2005 - 2005
Sankyo Pharmaceuticals 2004 - 2005
Baxter Healthcare 2002 - 2004
Skills
Global HCP Transparency, Change Management..., Aggregate Spend..., Strategic Consulting -..., Transparency, HCP, Change Management, Training, Management Consulting, Leadership, Governance, Management, Business Process, Pharmaceutical Industry, Corporate Governance, Medical Devices, Mergers & Acquisitions, Cross-functional Team..., Quality Assurance, Strategy, Process Improvement, Contract Management, Project Management, Business Process..., Risk Management, Sarbanes-Oxley Act
Education
Oklahoma City University 2000 — 2000
MBA
Resonetics August 2012 - Present
Tegra Medical December 2008 - August 2012
Web Industries, Inc. May 2007 - December 2008
Accellent Orthopaedics September 2004 - November 2006
MedSource Technologies, Inc. June 2001 - September 2004
ACT Medical, Inc. December 1996 - June 2000
Genzyme Surgical Products January 1995 - December 1996
Edwards Lifesciences January 1991 - December 1995
Johnson & Johnson Medical Inc. February 1987 - January 1991
Whitehall Laboratories June 1984 - February 1987
Skills
Medical Devices, ISO 13485, Manufacturing, Injection Molding, Orthopedics
Education
Northeastern University 1978 — 1984
B.S.B.A., Marketing
Edwards Lifesciences December 2014 - Present
self-employed April 2014 - December 2014
Abbott Medical Optics Inc. March 2009 - March 2014
Advanced Medical Optics, Inc. February 2006 - February 2009
Morris Polich & Purdy LLP January 1998 - February 2006
Morris Polich & Purdy LLP September 1992 - December 1997
Skills
Medical Devices, Litigation, Commercial Litigation, Employment Law, Product Liability, Civil Litigation, FDA, Legal Compliance, Insurance, Clinical Trials, Privacy Law, Pharmaceutical Industry, Leadership, Trademarks
Education
University of San Diego School of Law 1989 — 1992
J.D., Law
Northwestern University 1985 — 1989
B.A., Economics, Psychology
Edwards Lifesciences December 2007 - Present
The Mortgage Coach August 2005 - December 2007
The Geneva Companies July 1990 - April 2005
Skills
Leadership, Product Launch, Strategy, Marketing, Strategic Planning, Social Networking, Hospitals, Management, Social Media Marketing, Marketing Strategy, Office Management, Project Management, Event Planning, Team Building, Process Improvement, Online Marketing, Email Marketing, Medical Devices, Marketing Communications, Customer Service, Digital Marketing, Salesforce.com, Social Media, Online Advertising, PowerPoint
Education
Orange Coast College 1985 — 1987
Newport Harbor High School 1982 — 1985
RSI Home Products May 2008 - Present
RSI Home Products 2008 - Present
Fremont Investment & Loan 2003 - 2008
Edwards Lifesciences September 1987 - July 2003
Martin Marietta Data Systems 1986 - 1987
Education
Orange Coast College 1982 — 1984
Edwards Lifesciences ManagerToshiba America Info Sys1995 - 2000
ADP 1979 - 1996
Skills
HRIS, Medical Devices, Process Improvement, Cross-functional Team..., Training, Performance Management, Management, Strategy, Business Process..., Leadership, Employee Relations
Education
National University 1974 — 1979
Edwards Lifesciences 2007 - Present
Abbott Vascular, Cardiac Therapies (formerly Guidant) 2005 - 2007
Kyocera America 2001 - 2003
Education
Lincoln County High
Montana State University-Bozeman
Edwards Lifesciences September 2012 - Present
Merck 2009 - 2012
Merck & Co. Inc. January 2007 - October 2009
Education
Northern Arizona University 1992 — 1994
AcuFocus April 2012 - Present
Bausch & Lomb March 2010 - April 2012
VertiFlex Inc. July 2008 - December 2009
Edwards Lifesciences August 2006 - July 2008
ICF International September 2003 - August 2006
United States Marine Corps June 1998 - September 2003
Skills
FDA, Regulations, Medical Devices, ISO 13485, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, CAPA, Quality System, Validation, PMA, Design Control, V&V, GMP, ISO 14971, CE marking, Quality Assurance, Product Launch, 21 CFR Part 11, Change Control, Quality Management, FDA GMP, Medical Device Directive, Clinical Trials, IND, 21 CFR, Sop, Biocompatibility, Biotechnology, Clinical Development, Commercialization, Technology Transfer, SOP
Education
Northeastern University 2011 — 2013
MBA, Healthcare
Western Washington University 1992 — 1996
Edwards Lifesciences April 2014 - Present
Gong & Xi Consulting LLC. October 2010 - Present
Volcano Corporation September 2012 - April 2014
Medtronic MiniMed June 2006 - September 2011
Hewlett-Packard Laboratories 2007 - 2007
Skills
R&D, Medical Devices, Biomedical Engineering, Nanotechnology, Sensors, Design of Experiments, Labview, Characterization, Product Development, Materials Science, Design Control, ISO 13485, FDA, MEMS, Quality System, Six Sigma, Solidworks, Six sigma Black Belt, Root Cause Analysis, V&V, Manufacturing, Validation, Physics
Education
University of California, Los Angeles - Engineer school 2004 — 2008
Doctor of Philosophy (Ph.D.), Materials Science and Engineering
University of California, Los Angeles 2002 — 2004
Master's degree, Mechanical Engineering
Nanjing University 1996 — 2002
Bachelor & Master degree, Physics
Boston Scientific September 2012 - June 2014
Abbott Medical Optics March 2012 - September 2012
Youth With A Mission (YWAM) September 2010 - March 2011
Edwards Lifesciences July 2009 - September 2009
Edwards Lifesciences January 2009 - March 2009
Northwestern University - University Career Services (UCS) September 2005 - March 2009
Northrop Grumman Corporation April 2007 - September 2007
Northrop Grumman Corporation June 2006 - September 2006
Skills
Biomedical Engineering, Quality Assurance, Microsoft Office, Matlab, Design Control, Medical Devices, Labview, Gage R&R, Minitab, CAPA, Material Review Board, Quality System, DMAIC, Process Improvement, Six Sigma, FDA, Quality Control, Continuous Improvement, V, Cross-functional Team..., Quality Auditing, Engineering, Data Analysis, Biotechnology, Technical Writing, Lifesciences, FMEA, Visio, SPC, Product Design, Product Development, Statistics, Product Launch, Root Cause Analysis, FDA GMP, Biomaterials, Lean Manufacturing, Design for Manufacturing, Validation, Design of Experiments, ISO 13485, ISO 14971, Rapid Prototyping
Education
Northwestern University 2008 — 2010
M.S., Biomedical Engineering
Northwestern University 2004 — 2008
B.S., Electrical Engineering
Sage Hill School 2000 — 2003
Sonendo®, Inc. July 2014 - Present
Edwards Lifesciences September 2007 - July 2014
Applied Biosystems September 2001 - 2007
Hyseq Inc July 1997 - August 2001
Skills
Program Management, Operations Management, Product Development, International Project..., Manufacturing..., Cross-functional Team..., Leadership, Medical Devices, Six Sigma, Quality System, Lean Manufacturing, Biotechnology, Supply Chain, Pharmaceutical Industry, Quality Control, Automation, Clinical Trials, Supply Chain Operations, DFMEA, DFSS, FDA GMP, Sales Operations, Risk Management, SPC, Business Strategy, Mechanical Engineering, DFMA, Technical Leadership, Product R&D, R&D Operations, Operational Planning, PTC Pro/Engineer, Java, VBA, MS Project, Teamcenter, JDE Enterprise One, Design Strategy, Semiconductor Industry, Aerospace Engineering, Distribution Logistics, Cost Reduction..., Strategic Leadership, Bilingual Proficiency
Education
Agile Product Development 2015 — 2015
Certified Agile Product Development SCRUM Master, Project Management
ASQ (American Sociaty of Quality) 6Sigma Black Belt 2009 — 2009
Certificate, Six Sigma, LEAN black belt
UC Irvine Extension 2008 — 2009
Certificate, Medical Device Development
PMI 2006 — 2006
PMP, Preject Manangement
UC Berkeley Extension 2002 — 2005
Certification, Project Management, Software Archetecture
Wichita State University 1995 — 1997
MS, Mechanical Engineering
Northwestern Polytechnical University 1990 — 1994
BS, Aerospace
Edwards Lifesciences June 2014 - Present
HeartWare Inc January 2012 - Present
Skills
Medical Devices, Six Sigma, Cross-functional Team..., Process Improvement, Product Development, Continuous Improvement, Manufacturing, Lean Manufacturing, Quality System, Strategic Planning, Project Management, Team Building, FDA, Product Launch, Product Management, Quality Assurance, Minitab, Forecasting, ISO 13485, Operations Management, Supply Chain, Management, Start-ups, Program Management, Design of Experiments, SAP, Leadership, Project Planning
Education
Nova Southeastern University 2003 — 2005
MBA, Finance
University of Minnesota-Twin Cities 1987 — 1990
BS, Mechanical / Industrial Engineering
University of Wisconsin-Madison 1980 — 1984
BS, Meteorology
Stryker September 2015 - Present
Stryker July 2015 - September 2015
Stryker June 2013 - July 2015
Stryker July 2012 - June 2013
Edwards Lifesciences January 2011 - July 2012
Edwards Lifesciences March 2010 - March 2011
Edwards Lifesciences March 2007 - March 2010
Edwards Lifesciences January 2006 - March 2007
Wyeth Consumer Healthcare January 2004 - June 2004
Skills
ISO 13485, Design of Experiments, CAPA, Six Sigma, Medical Devices, Design Control, Validation, Packaging Engineering, Cross-functional Team..., V&V, FDA, Lean Manufacturing, Quality System
Education
Michigan State University 1998 — 2005
BS, Packaging
Interface Associates January 2008 - Present
Edwards Lifesciences March 2001 - January 2008
Education
North Carolina State University 1982 — 1985
Edwards Lifesciences June 2013 - May 2014
Edwards Lifesciences January 2011 - June 2013
Edwards Lifesciences July 2009 - January 2011
Edwards Lifesciences May 2008 - August 2008
Skills
Biomedical Engineering, Labview, Matlab, Medical Devices, Design Control, FDA, Biomaterials, ISO 13485, CAPA, Design of Experiments, Minitab, Manufacturing, Process Simulation
Education
Northwestern University - Kellogg School of Management 2014 — 2016
Master of Business Administration (M.B.A.)
University of Southern California 2009 — 2011
Master of Science (MS), Medical Device and Diagnostics Engineering
University of Southern California 2005 — 2009
BS, Biomedical Engineering
Edwards Lifesciences April 2005 - Present
Guidant 2003 - 2005
Eli Lilly 2001 - 2003
Skills
Medical Devices, Territory, Market Development, Hospitals, Sales, Marketing, Sales Operations, Capital Equipment, Operating Room, Pharmaceutical Sales, Diabetes, Product Launch, Surgeons, Surgical Instruments, Urology, Disposables, Cardiology, Selling Skills, Vascular, Orthopedic
Education
Michigan State University - The Eli Broad Graduate School of Management
MBA, Marketing and Supply Chain Management (dual emphasis), 3.7/4.0
Michigan State University - The Eli Broad Graduate School of Management
BA, Finance, 3.7/4.0
MicroVention July 2011 - Present
Hansen Medical 2010 - July 2011
MiCardia Corporation October 2008 - August 2009
Interface Associates, Inc. January 2008 - October 2008
Edwards Lifesciences March 2001 - January 2008
Johnson & Johnson 1991 - 1998
Skills
Medical Devices, Design Control, ISO 13485, FDA, Biomedical Engineering, D.O.E., Decision Analysis/Fast..., Emotional Intelligence..., Coaching Team for Core..., R&D, Catheters, V&V, Validation, CAPA, Manufacturing..., Process Simulation, Quality System, Design of Experiments, Manufacturing
Education
North Carolina State University 1982 — 1985
BS, Mechanical Engineering
Edwards Lifesciences July 2014 - Present
Edwards Lifesciences March 2009 - July 2014
Edwards Lifesciences January 2008 - March 2009
Edwards Lifesciences January 2007 - January 2008
Edwards Lifesciences January 2006 - January 2007
Edwards Lifesciences July 2004 - January 2006
Advanced Stent Technologies 2001 - 2001
Skills
Medical Devices, FDA, ISO 13485, Quality System, Biomedical Engineering, Validation, ISO 14971, R&D, Design of Experiments, Design Control
Education
University of California, San Diego 2002 — 2004
MS, Bioengineering
Northwestern University 1998 — 2002
BS, Chemical Engineering
Edwards Lifesciences September 2014 - Present
Abbott Medical Optics June 2011 - September 2014
Tachus Technologies Inc. April 2009 - July 2011
Avaya July 2007 - April 2009
Alcatel Lucent January 2006 - April 2008
Power Dynamics May 2001 - December 2005
Avaya January 2000 - April 2001
Symbol Technologies (Motorola) September 1995 - December 2000
Skills
Project Planning, New Business Development, Start-ups, Team Building, Logistics, Change Management, ERP, Pricing, Strategy, Contract Management, Inventory Management, Restricted Substances..., Networking, Strategic Planning, Engineering, Engineering Management, Vendor Management, Supply Management, Quality Management, Entrepreneurship, Management, Strategic Sourcing, Product Stewardship, RoHS, REACH Compliance, Conflict Minerals
Education
New York Institute of Technology 1994 — 1996
MSc, Electrical Engineering
New York Institute of Technology 1989 — 1993
Bsc, Electrical Engineering
Morningstar Consulting Group LLC June 1997 - Present
ValveXchange, Inc. November 2010 - January 2015
Teleflex Medical April 2008 - April 2009
Edwards Lifesciences November 2006 - August 2007
Silverglide Surgical Technologies September 1998 - June 2006
Dolphin Medical January 1998 - December 2001
Tomtec Imaging Systems Inc. June 1995 - June 1997
Datex-Ohmeda 1988 - 1995
Telectronics 1985 - 1988
Cobe Laboratories 1983 - 1985
Skills
Medical Devices, Quality System, Design Control, Validation, Regulatory Affairs, GMP, ISO 13485, Regulatory Submissions, Start-ups, CE marking, Product Development, Manufacturing, Project Management, Clinical Trials, Strategy, Cross-functional Team..., Product Launch, Commercialization, V&V, Sterilization, Risk Management, Cardiovascular Devices, Angel Investing, Venture Capital, Due Diligence, Entrepreneurship, Six Sigma
Education
Michigan State University 1975 — 1980
Bachelor of Science (BS), Electrical and Electronics Engineering
Maquet Cardiovascular November 2007 - Present
Edwards Lifesciences October 2006 - November 2007
Guidant December 2001 - October 2006
Education
Nova Southeastern University 1998 — 2000
BS, Physician Assistant
University of Florida 1995 — 1998
Psychology
Mountain West HR Solutions August 2005 - Present
Morgan Philpot Campaign 2010 - 2010
Catholic Business Network 2008 - 2010
Hines Horticulture 2007 - 2008
Hines Horticulture 2007 - 2008
Edwards Lifesciences May 1999 - July 2003
BP Amoco August 1981 - May 1999
Amoco 1995 - 1999
Skills
Talent Acquisition, Deferred Compensation, Human Resources, Employment Law, HR Policies, Personnel Management, HR Consulting, Succession Planning, Performance Management, Employee Relations, Organizational..., Labor Relations, Team Building, Recruiting, Budgets, Strategic Planning, Management, Management Consulting, Policy, Onboarding, Leadership Development, Workforce Planning, Career Development, Organizational Design, HRIS, Employee Training, Talent Management, Employee Engagement, Executive Coaching, Organizational..., Employee Benefits, Coaching, Mergers & Acquisitions, Analysis, Change Management, Strategy, Benefits Administration, Training, Negotiation
Education
University of Alabama 1979 — 1981
MA, Human Resources Management
Mississippi State University 1971 — 1973
Master of Science, Clinical Psychology
Edwards Lifesciences January 2011 - Present
Financial Freedom January 2011 - February 2011
NGK Spark Plugs (U.S.A.) April 1993 - May 2006
Skills
Outlook, Customer Service, Administrative..., PowerPoint, Microsoft Office, Sales, Management, Marketing, Customer Satisfaction
Education
Northeastern University 1972 — 1973
Dental Assisting
HealthStream 2014 - Present
Omnicell 2008 - 2014
American Medical ID 2007 - 2008
DRC Consulting Services of Houston 2005 - 2007
Bausch & Lomb 2003 - 2005
Jostra 2000 - 2003
Edwards Lifesciences 1999 - 2000
Baxter Healthcare 1999 - 1999
Skills
Product Management, Marketing, Management, Leadership, Training, Cross-functional Team..., Competitive Intelligence, Pricing, Strategy, Sales, Marketing Strategy, Healthcare, Product Launch, Team Building, Product Development, CRM, Competitive Analysis, Sales Process, Sales Management, Agile Methodologies, Medical Devices, Product Marketing, Strategic Planning, Capital Equipment, Medical Education, Health Education, Scrum, End of Life, Market Entry, Brand Development, Process Improvement, Sales Operations, Market Development, Project Management
Education
University of California, Irvine 2001 — 2002
Certificate, Medical Product Development
University of California, Irvine 2000 — 2001
Certificate, Marketing of Technical Products & Services and Medical Product Development
Orange Coast College 1996 — 1997
Certificate, International Marketing
University of California, Irvine 1990 — 1993
BA, Social Science
Edwards Lifesciences July 2006 - Present
Skills
Design Control, ISO 13485, Medical Devices, FDA, Biomedical Engineering, V&V, R&D, Design of Experiments, ISO 14971, Design for Manufacturing, Quality System, Minitab
Education
Pacific Union College
Walla Walla College
Bachelor of Science (BS), Mechanical Engineering
Quality Systems International (QSI) 1991 - Present
OCRA - Orange County Regulatory Affairs 2001 - 2010
'Many & varied' (Consultancy) 1985 - 2010
Masimo Corporation 2007 - 2009
Edwards Lifesciences 1979 - 2009
The Toro Company 1996 - 1997
The Toro Company 1996 - 1997
The Toro Company 1996 - 1997
The Toro Company 1996 - 1997
Baxter Healthcare 1978 - 1991
Skills
Medical Devices, ISO 13485, Quality System, Biotechnology, Validation, CAPA, Quality Control, GMP, Regulatory Affairs, FDA, Start-ups, 21 CFR Part 11, Product Development, Design Control, V&V, Product Launch, Biomedical Engineering, Commercialization, Lifesciences, Manufacturing, Quality Assurance, R&D, Software Documentation, Change Control, Process Improvement, Technology Transfer, Life Sciences
Education
Pepperdine University, The George L. Graziadio School of Business and Management 1980 — 1982
MBA, Strategy and Statistics
University of California, Irvine 1975 — 1977
BS, Biological Sciences
Orange Coast College 1968 — 1970
AS, Electronics Technology
Other
Edwards Lifesciences December 2011 - Present
InfraReDx August 2010 - December 2011
BSCI April 2002 - April 2011
Boston Scientific April 2002 - April 2011
Boston Scientific April 2002 - April 2011
Datascope October 1995 - April 2002
EV3 Medical January 2000 - January 2001
Datascope Corporation January 1996 - January 2001
Interventional Technologies January 1994 - January 1996
Baxter Edwards January 1991 - January 1994
Skills
Cath Lab, Medical Devices, Cardiology, Vascular, Clinical, Clinical Trials, Medical Education, Interventional..., Cardiac, Neurology, Imaging, Operating Room, Clinical Research, Capital Equipment, Product Launch, Surgeons, Healthcare, Interventional Radiology, Digital Imaging, Disposables, Electrophysiology, FDA, Market Development, Medical Imaging, Medicine, Radiology, Surgery
Education
Cardiovascular Tech
Mount Saint Mary College
The University of New Mexico
First Team Real Estate Systems AdministratorJostra USA2001 - 2003
Jostra Corp 2001 - 2003
Edwards Lifesciences 2000 - 2001
Bentley 1999 - 2001
Baxter/Bentley 1989 - 2001
CADME 1985 - 1989
Skills
Short Sales, Selling
Education
National University
BSCS, Software Engineering
National University
MCSE, Software Engineering
Palomar College
UCSD
BSEE, EECS
Accriva Diagnostics January 2015 - Present
Edwards Lifesciences June 2014 - February 2015
Biosense Webster November 2013 - June 2014
Abbott Vascular Devices May 2006 - July 2013
Hunter Industries July 1998 - January 2006
Kendall Healthcare August 1990 - June 1998
Skills
CAPA, Lean Manufacturing, Medical Devices, Six Sigma, Automation, Process Improvement, Manufacturing, Testing, Injection Molding, V&V, ISO 13485, SPC, Quality System, Validation, Root Cause Analysis
Education
National University 1990 — 1995
BA, Operations Management
National University 1990 — 1995
BA Operations Management, Business Administration, Management and Operations
Edwards Lifesciences April 2014 - Present
Skills
Project Management, Facilities Engineering, Distribution Logistics, Industrial Engineering, Lean Manufacturing
Education
Pepperdine University 1988 — 1990
Master of Business Administration (M.B.A.)
University of Florida 1983 — 1984
Master's Degree, Industrial and System Engineering
National Tsing Hua University 1974 — 1978
Bachelor's Degree, Industrial Engineering
Edwards Lifesciences February 2013 - Present
Maquet Cardiovascular July 2012 - February 2013
MAQUET June 2007 - July 2012
University of Medicine and Dentistry of New Jersey March 2002 - January 2006
Skills
ISO 13485, Cross-functional Team..., Product Development, FDA, Medical Devices, Biomedical Engineering, Design Control, Quality System, Product Launch, ISO 14971, R, Validation, Clinical Research, Catheters, Interventional..., Operating Room, 21 CFR, CE marking, CAPA, R&D, Regulatory Affairs, V&V, Cardiology, Manufacturing, Capital Equipment
Education
New Jersey Institute of Technology 2006 — 2008
M.S., Biomedical Engineering
New Jersey Institute of Technology 2001 — 2006
B.S., BioMedical Engineering
Edwards Lifesciences
Skills
ISO 13485, Medical Devices, Design Control, Biomedical Engineering, Design of Experiments, FDA
Education
Osmania University
The AES Corporation September 2015 - Present
AES April 2013 - August 2015
KPMG July 2011 - March 2013
KPMG July 2010 - July 2011
Moritz College of Law January 2009 - May 2009
Keating, Muething & Klekamp May 2008 - August 2008
Moritz College of Law Civil Law Clinic May 2007 - August 2007
Edwards Lifesciences March 2005 - September 2005
Education
New York University School of Law 2009 — 2010
LL.M, Taxation
The Ohio State University Moritz College of Law
Juris Doctor
University of Cincinnati 2001 — 2006
BBA, Major: Operations Management, Minors: International Business & German
Edwards Lifesciences May 2006 - Present
Philips Healthcare (Raytel Cardiac Services) 2003 - 2006
Ft Lauderdale Orthopaedic Surgery and Sports Medicine September 2002 - June 2003
Interventional Cardiology in FL February 1999 - September 2002
Skills
Medical Devices, Hospitals, Cardiology, Strategic Planning, Disposables, Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, Public Speaking, Research, English, Windows, Outlook, Teaching, Budgets, Negotiation, Editing, Photoshop, HTML, C++, C, Java, Capital Equipment, Clinical Research, Healthcare, Cardiac Surgery, Interventional..., Operating Room, Surgery
Education
Nova Southeastern University 1996 — 1998
Bachelor of Science (B.S.), Physician Assistant
Oklahoma State University 1986 — 1990
Bachelor of Science (B.S.), Kinesiology and Exercise Science
Edwards Lifesciences 2010 - Present
St. Jude Medical, CRMD 2009 - 2010
Thoratec Corporation 2006 - 2009
Skills
Design Control, ISO 13485, ISO 14971, Design of Experiments, Medical Devices, Biomedical Engineering, CAPA, V&V, FDA, Quality System, SPC, Minitab, FMEA, CE marking, R&D, Validation, Root Cause Analysis, Supplier Quality, CQE, Catheters
Education
Northeastern University
MS Mechanical Engineering, Material Science
Worcester Polytechnic Institute
BS Mechanical Engineering
Edwards Lifesciences May 2011 - Present
Medtronic Vascular January 1997 - April 2011
AngioDynamics April 1995 - January 1997
Skills
Interventional..., Medical Devices, Cath Lab, Operating Room, Endovascular, Transcatheter Heart...
Education
Mississippi State University 1988 — 1992
Bachelor of Science (BS), Business Administration, Management and Operations
Tenorcorp April 2012 - Present
Edwards Lifesciences January 2005 - April 2012
BioIntegra January 2003 - January 2005
sanofi-aventis January 2002 - January 2003
Elan Pharmaceuticals January 1999 - January 2002
Johnson & Johnson Medical January 1986 - January 1999
Skills
Leadership, Training, Leadership Development..., Social Intelligence, Strategic Planning, Healthcare, Business Planning, Sales Leadership..., Corporate Management, Product Marketing, Medical Devices, Cardiology, Sales Management, Start-ups, Oncology, New Business Development, Biotechnology, Hospitals, Team Building, Diabetes, Customer Service, Pharmaceutical Industry, Contract Negotiation, Radiology, Health Care Marketing, Vascular, Manufacturing, Team Management, Cardiac, Interventional Radiology, Surgical Instruments, Clinical, Health Care Facilities, Customer Relations, Pharmaceuticals, Budgeting, Hematology, National Account..., National Account Sales, Market Planning, Board Presentations, Management Presentations, Catheters, Cardiovascular Medicine, Cancer, Heart Disease, Stents, Biopharmaceuticals, Medical Diagnostics
Education
Northwestern University
Business
Northwestern University
Edwards Lifesciences September 2000 - July 2015
Instrumentation Laboratory 1989 - 2000
Skills
Medical Devices
Education
Northwestern University
Purdue University
Unique from Nature, LLC August 2010 - Present
Aurora Health Care December 1995 - April 2007
Edwards Lifesciences December 1995 - July 1996
Aurora Health Care April 1991 - December 1995
Midwest Express Airlines August 1987 - July 1990
Skills
Registered Nurses, Aromatherapy, Essential Oils, Raindrop Technique, Emotional Release..., Young Living..., ICU, Critical Care, Healthcare, Pain Management, Wellness, Clinical Research, Hospitals, Healing, Holistic Health, Nutrition, Health Education, Wellness Coaching
Education
Milwaukee Area Technical College 1992 — 1995
Registered Nurse, Registered Nursing
Freelance June 2009 - Present
Kargo March 2015 - Present
American Apparel January 2011 - February 2015
American Apparel June 2009 - December 2010
Edwards Lifesciences July 2007 - June 2009
Skills
Online Advertising, Marketing, Conversant Ad Server, Social Media Marketing, Advertising, Microsoft Office, Google Adwords, Email Marketing, Web Analytics, Web Marketing, Online Marketing, Facebook, Digital Strategy, Blogging, SEM, Digital Marketing
Education
Pasadena City College 2013 — 2015
Associates, Mathematics
University of California, Riverside 2003 — 2007
Studied towards BA, Economics
Edwards Lifesciences September 2013 - Present
Kulicke and Soffa June 2004 - Present
Fleetwood February 2004 - May 2004
Hartwell Dzus Inc June 2000 - January 2004
Hartwell commercial Products 2000 - 2004
Skills
O.O. Design and..., Java, VB.NET, ASP.NET, Web Development, Microsoft Office, Dreamweaver, Pro Intralink, Intralink, Wildfire, Solidworks, UGS NX7.5, GUI development, Database Design, AutoCAD, AutoCAD Mechanical, MatrixOne, Programming, Manufacturing, Finite Element Analysis, Design of Experiments, Electronics, Semiconductors, Engineering, Automation, Product Development, Semiconductor Industry, Robotics, Pro Engineer, Manufacturing..., Injection Molding, SPC, FMEA, GD&T, Engineering Management, R&D, Failure Analysis, Process Engineering, Lean Manufacturing, Testing, Machining, Process Simulation, CAD, Machine Tools, Minitab, Six Sigma, Continuous Improvement, Product Design, Materials, Mechanical Engineering
Education
University of Phoenix 2010 — 2011
B.S, Information Technology; Software Engineering
University of Phoenix 2009 — 2011
BSIT, Software Engineering
Mount San Antonio College 2000 — 2006
A.S, General Education
MTI College 1997 — 1998
A.S, Electro-Mechanical Design and Drafting
Edwards Lifesciences August 2011 - Present
Medtronic Spine & Biologics April 2007 - August 2011
ProHealth Chiropractic and Acupuncture Center October 2002 - February 2008
Pain Management Specialists of Indianapolis August 1995 - June 2002
Skills
Pain Management, Spine, Rehabilitation, Training, Treatment, Physicians, Public Speaking, Operating Room, Medical Devices, Surgeons, Capital Equipment, Marketing
Education
Palmer College of Chiropractic San Jose, Calif. 1986 — 1990
DC, Chiropractic, Biology
Symmetry Surgical April 2015 - Present
Richard Wolf Medical Instruments Corporation February 2009 - March 2015
FUJIFILM Medical Systems U.S.A., Inc. February 2009 - March 2015
Edwards Lifesciences June 2007 - January 2009
Baxter International Inc. January 2006 - June 2007
Karl Storz Endoscopy October 1996 - January 2006
Skills
Disposables, Medical Devices, Capital Equipment, Surgeons, Operating Room, Surgery, Surgical Instruments, Urology, Neurosurgery, Orthopedic, Interventional Radiology
Education
Northern Illinois University 1975 — 1979
Bachelor’s Degree, Business, Management, Marketing, and Related Support Services
Edwards Lifesciences 2000 - 2006
WD, a Western Digital company 1996 - 2000
Arthur Andersen LLP January 1993 - December 1996
Education
Northwestern University 1986 — 1990
B.A., Psychology
Edwards Lifesciences January 2014 - Present
Medical Simulation Corporation March 2012 - December 2013
Medical Simulation Corporation June 2008 - March 2012
Medical Simulation Corporation April 2007 - June 2008
Skills
Nursing, Critical Care, ACLS, Hospitals, Healthcare Management, Healthcare, eMAR, Vascular, Surgery, Cardiology, Inpatient, Ambulatory, Disease Management, Cerner, Patient Safety
Education
University of Arkansas for Medical Sciences 1999 — 2002
BSN, Nursing
NorthWest Arkansas Community College 1996 — 1999
ADN, Nursing
Edwards Lifesciences June 2006 - Present
Skills
ISO 13485, CAPA, FDA, Quality System, Design Control, ISO 14971, Validation, Medical Devices, GMP, Quality Assurance, FMEA, Auditing, Teaching, Employee Training
Education
University of La Verne 1990 — 1993
Master of Business Administration (MBA), Business Management
National Institute of Technology Surat 1980 — 1984
Bachelor of Science (BS), Mechanical Engineering
SpecialtyCare, Inc. January 2012 - Present
SpecialtyCare June 2009 - December 2012
Fresenius Medical Care April 2002 - June 2009
Edwards Lifesciences January 1999 - April 2002
Skills
Contract Negotiation, Contract Management, Operations Management, Sales Operations, Process Improvement, Healthcare, Critical Care, Hospitals, Strategic Planning, Business Development, Management, Budgets, Sales, New Business Development, Team Building, Leadership, Sales Management, Customer Service, Outsourcing, Microsoft Office, Selling, Outlook, Salesforce.com, Operating Room, Medical Devices, Sales Process, Capital Equipment, Surgery
Education
Northeastern University 1989 — 1990
Bachelor of Science (BS), Perfusion Technology/Perfusionist
Hahnemann University 1985 — 1986
Allied Sciences, Respiratory Care Therapy/Therapist
University of Delaware 1979 — 1983
Bachelor of Sciences, Physical Education Teaching and Coaching
Sandi Parsons Consulting 1999 - Present
Covidien (consultant) 2012 - 2013
Edwards Lifesciences 2010 - 2012
Baxter Bioscience (consultant) 2008 - 2010
Clinical Consultant 1999 - 2008
Skills
R&D, Project Management, FDA, Medical Devices, Cross-functional Team..., Program Management, Data Analysis, Project Planning, Research, Biotechnology Industry, CRO, GCP, Pharmaceutical Industry, Contract Negotiation, Budget Process, Clinical Research, Respiratory Therapy, Team Building, Teamwork, Healthcare Management, Vendor Management, Vendor Relationships
Education
Institute for Integrative Nutrion 2014 — 2015
Holistic Health Coach, Nutrition and Wellness Studies
University of La Verne
Bachelor of Science (BSc), Business Administration and Management
Mt. San Antonio College
Associate of Science (A.S.), Respiratory Therapy
Edwards Lifesciences July 2007 - Present
3M Health Care June 2000 - July 2007
Skills
Design of Experiments, ISO 13485
Education
Michigan Technological University 1995 — 2000
Bachelor of Science (B.S.), Chemical Engineering
Spectranetics January 2012 - Present
Edwards Lifesciences February 2009 - January 2012
Ethicon March 2008 - February 2009
Education
North Carolina State University
Bachelor of Science (BS), Food Chemistry
Edwards Lifesciences November 2014 - Present
University of Minnesota 2013 - 2014
Northwestern University, Feinberg School of Medicine June 2010 - July 2011
The University of Chicago February 2003 - June 2010
The first Afiliated Hospital of Jiangxi Medical College September 1990 - April 1995
Skills
clinical research, Clinical Trials, Regulatory Affairs, Cancer Research, clinical medicine, Molecular Biology, Molecular Virology
Education
Nagoya University 1996 — 2001
Ph.D, Molecular Virology
Jiangxi Medical College 1985 — 1990
Bachelor of Medicine, Clinical Medicine