SynCardia Systems, Inc.
SynCardia Systems, LLC, headquartered in Tucson, Arizona, was founded in 2001 and is the sole manufacturer and provider of the world's only clinically proven and commercially approved Total Artificial Heart. Headquarters: Tucson, AZ Founded: 2001 Key people: Michael Garippa, President & CEO Type of business: Privately held company
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SynCardia Systems, Inc. Employees
SynCardia Systems, Inc. January 2012 - Present
CardiacAssist, Inc. September 2006 - January 2012
Cleveland Clinic August 1999 - August 2006
US Navy August 1990 - August 1994
Skills
Medical Devices, Operating Room, Clinical Research, Cardiology, Interventional Radiology, Vascular, Cardiac Surgery, Mechanical Circulatory..., Registered Nurse, Transplant, Critical Care, Cath Lab, Interventional..., Hospitals, Surgery, Healthcare, ICU, Nursing, Wound Care, Acute Care, ACLS, Medical/Surgical, Patient Education, Sales, Account Management, Heart Failure, Disposables, Surgeons, Market Development, Clinical Trials, Capital Equipment, Medical Equipment, Patient Safety, Patient Advocacy, Electrophysiology, Healthcare Industry, Biotechnology, Cardiovascular Disease, Cardiac..., Ventricular Assist..., Product Launch, Medical Sales, Cardiac Rhythm..., Medical-Surgical
Education
Kent State University 1997 — 2001
Bachelor of Science in Nursing, Registered Nursing/Registered Nurse
Brecksville-Broadview Hts. High School 1986 — 1990
Defense Health Agency October 2013 - Present
Self-employed July 1995 - Present
OSD Force Health Protection and Readiness, Health Affairs October 2011 - October 2013
SynCardia Systems, Inc. 2010 - 2013
Tucson Toros Professional Baseball 2009 - 2011
Arizona Diamondbacks January 2007 - January 2010
Skills
Aerospace Medicine, Masters of Public..., Military Medicine, Endocrine Surgery, Military, DoD, Defense, Emergency Management, Army, Medicine, Leadership, Surgery, Healthcare, Public Health, Hospitals, Critical Care, Readiness, Afghanistan, Emergency Medicine, Aviation, Human Resources, Combat, Medical Education, ACLS, Clinical Research, Disaster Response, Informatics
Education
Gateway High School
University of Virginia 1982 — 1986
Bachelor of Arts (B.A.), Echols Scholar
Virginia Commonwealth University School of Medicine 1986 — 1990
Doctor of Medicine (MD)
Benedictine University 2007 — 2010
Master of Public Health (M.P.H.), Disaster Management
USAF School of Aerospace Medicine 1985 — 1985
Flight Surgeon, Aerospace Physiology and Medicine
Syracuse University
Fellow, National Security Studies, National Security Policy Studies
SynCardia Systems, Inc. August 2011 - Present
DowKokam July 2011 - August 2011
Panacis February 2010 - July 2011
Lux Aviation April 2006 - February 2010
Securaplane August 1988 - April 2006
Skills
Test Equipment, R&D, Avionics, Engineering, Electronics, Batteries, CAD, Testing, Automation, Debugging, Wiring, Component, Cross-functional Team..., Design of Experiments, Manufacturing, PCB design, Wireless, Power Supplies, Electrical Engineering, Design for Manufacturing, Failure Analysis, Systems Engineering, Analog, Root Cause Analysis
Education
Pima Community College 1982 — 1986
Associate of Science, Electronics Engineering
SynCardia Systems, Inc. March 2015 - Present
Response Biomedical Corporation February 2013 - February 2015
Teleflex Medical July 2005 - January 2013
Stryker June 2003 - June 2005
Capital area perfusion it's 1992 - 1998
Capital area perfusion it's 1992 - 1998
Skills
Medical Devices, Lifesciences, Sales Operations, Capital Equipment, Cardiology, Product Launch, Biotechnology, Commercialization, Product Development, Market Development, Operating Room, Disposables, Surgeons, Vascular, Urology, Surgical Instruments, Sales, Sales Management, Interventional Radiology, Hospitals, FDA, Pharmaceutical Industry, Cross-functional Team..., ISO 13485, Hardware Diagnostics
Education
Our Lady of the Lake University 1999 — 2001
Master of Business Administration (MBA), Business Administration and Management, General
The University of Texas Health Science Center at Houston 1991 — 1992
Bachelor's of Science in Perfusion Technology, Perfusion Technology/Perfusionist
New Mexico State University August 2013 - Present
University of New Hampshire September 2008 - July 2013
University of New Hampshire September 2012 - December 2012
SynCardia Systems, Inc. June 2012 - September 2012
University of New Hampshire September 2009 - May 2012
Karlsruhe Institute of Technology (KIT) / University of Karlsruhe (TH) June 2009 - July 2009
Skills
Micromechanics, Mechanics of Materials, Composites, Mechanical Engineering, Materials Science, Statistical Modeling, Numerical Analysis, Engineering, Matlab, Design of Experiments, Finite Element Analysis, Digital Image Processing, Experimental Mechanics, Solid Mechanics, DIC, Solidworks, Ceramic materials, Theory of Elasticity, 3D Studio Max, Photoshop, 3D visualization, Web Design, MathCAD, Labview, Statistics, Microscopy, Fracture Mechanics, SolidWorks, Modeling
Education
University of New Hampshire 2008 — 2013
PhD, Micromechanics, Mechanical Engineering
University of New Hampshire 2012 — 2013
Cognate in College Teaching, College Teaching
Kyiv Polytechnic Institute 2003 — 2008
BSc, Honors Degree, Mechanical Engineering
DNA Electronics May 2015 - Present
SynCardia Systems, Inc. January 2013 - May 2015
Meggitt Securaplane Technolgies September 2010 - December 2012
Ventana Medical Systems June 2006 - December 2009
Raytheon Missile Systems May 1999 - June 2006
Abbott Laboratories January 1993 - January 1999
Skills
AS9100, Aerospace, Kaizen, Risk Management, Medical Device Product..., Process Validation, Design Validation and..., Supplier Management, External Audit, Internal Audit, Change Management, Documentation, Kanban, Lean Manufacturing, Social Networking, Quality Assurance, Quality Management, Team Leadership, Vendor Management, Vendor Relations, Verification, Quality System, Design Control, ISO 13485, Validation, CAPA, Quality Auditing, FDA, ISO 14971, Quality Control, Change Control, GMP, Medical Devices, 5S, V&V, Software Documentation, Cross-functional Team..., Failure Analysis, Supplier Quality, Corrective Actions, Continuous Improvement, Design of Experiments, ISO, Value Stream Mapping, SPC, DMAIC, CE marking, MRB, 21 CFR Part 11, Green Belt
Education
Thunderbird School of Global Management 2005 — 2005
Raytheon Global Leadership Certificate, Global Leadership
University of Phoenix 1999 — 2001
MBA, Global Management
Carthage College 1989 — 1993
BA, Biochemistry
Elk Mound HS 1986 — 1989
High School, General High School Studies with an emphasis on the sciences
SynCardia Systems, Inc. February 2013 - Present
The University of Iowa Health Care January 2011 - February 2013
The University of Iowa Health Care May 2009 - January 2011
The University of Iowa Health Care July 2003 - May 2009
Skills
Healthcare Management, Medical Devices, Team Building, Clinical Research, ICU, Cardiothoracic Surgery, Critical Care, Operating Room, Capital Equipment, Cardiac Surgery, Healthcare, Healthcare Information..., Process Improvement, Patient Safety, Epic Systems, Quality Improvement, Heart Failure, Hospitals, General Surgery, Surgery, Strategic Leadership, Clinical Trials, Cardiology, Nursing
Education
University of Iowa 2010 — 2015
Doctor, Nursing Practice in Health Systems, Golden Key International Honour Society
Coe College 1993 — 1997
BSN, Sigma Theta Tau
XERIDIEM MEDICAL DEVICES August 2015 - Present
SynCardia Systems, Inc. August 2014 - August 2015
Syncardia Systems, Inc. July 2012 - August 2014
Carondelet Health Network June 2008 - January 2012
Skills
Clinical Research, Hospitals, Healthcare, Phlebotomy, Medical Terminology, Biochemistry, Microsoft Excel, Fitness, HIPAA, OSHA, Cross-functional Team..., Organizational..., Customer Oriented, Data Analysis, Interpersonal Skill, Prioritisation, Training, Presentations, Multi Tasking, Self-driven, Dexterity, Cardiology, GMP, ISO 13485, Laboratory, Quality Assurance, FDA, Medical Devices, Quality System, Validation, Manufacturing Operations, R&D, Self-management, Quality Auditing
Education
University of Arizona 2004 — 2009
Bachelor of Science, Biochemistry and Psychology
Pima Medical Institute-Tucson 2008 — 2008
Certification, Phlebotomy Technician/Phlebotomist
Common Bond Development Group July 2014 - Present
SynCardia Systems, Inc. June 2013 - November 2013
Merrill Lynch Wealth Management August 2012 - December 2012
University of Arizona Interfraternity Council January 2012 - December 2012
Granite Escrow Services June 2011 - July 2011
Skills
Entrepreneurship, Leadership, Sales, Public Speaking, Social Networking, Communication, Management, Interpersonal Skill, Program Management, Apple, Microsoft Office, Investments, Risk Management, Marketing, OS X, Training, Commercial Real Estate, Real Estate Development, Real Estate, Research, Facebook
Education
University of Arizona, Eller College of Management 2010 — 2014
Bachelor of Science (B.S.), Business Management and Entrepreneurship
MyCase January 2015 - Present
CJ Affiliate by Conversant (formerly Commission Junction) March 2012 - December 2014
Tucson Medical Center August 2010 - December 2010
SynCardia Systems, Inc. June 2009 - May 2010
General Electric March 2008 - December 2008
U.S. Trade Representative, Executive Office of the President January 2006 - March 2008
Rep. John T. Doolittle, Conference Secretary, House of Representatives (CA-04) August 2005 - November 2005
National Republican Congressional Committee June 2003 - August 2003
Education
University of Arizona, Eller College of Management
MBA, Strategic Management & Marketing
University of California, Santa Barbara
BA, Business Economics, Political Science
SynCardia Systems, Inc. January 2014 - Present
Tucson Unified School District January 2005 - May 2013
CEO Support Systems January 2000 - December 2002
Western Water Technologies August 1996 - December 1999
Skills
Customer Service, Research, Teaching, Project Coordination, Project Management, Office Administration
Education
University of Arizona 1984 — 1988
BS, Geosciences
The Heritage Foundation June 2014 - August 2014
U.S. Senator Jeff Flake June 2013 - August 2013
SynCardia Systems, Inc. May 2012 - September 2012
Education
University of Pennsylvania 2011 — 2015
Bachelor of Arts (B.A.)
University of Notre Dame 2010 — 2010
SynCardia Systems, Inc. June 2015 - Present
The University of Arizona August 2014 - May 2015
SynCardia Systems, Inc. July 2014 - May 2015
The University of Arizona July 2013 - May 2015
The University of Arizona May 2012 - June 2013
Tucson Unified School District December 2011 - February 2013
The University of Arizona April 2010 - April 2012
Skills
Laboratory, Tissue Culture, Mammalian Cell Culture, Tissue Engineering, Microscopy, Cell, Aseptic Technique, Gel Electrophoresis, Cell Viability Assays, Cellular Assays, Cardiovascular Devices, Animal Models, Western Blotting, DNA, DNA extraction, Protein Purification, PCR, Cell Culture, ImageJ, Biomedical Engineering, Experimentation, Research, Medical Devices, Microsoft Office, Characterization, Microsoft Excel, Science, Biomaterials
Education
University of Arizona 2013 — 2015
Master of Science (M.S.), Biomedical Engineering
University of Arizona 2009 — 2013
Bachelor of Science (B.S.), Biomedical Engineering
The Writers Studio Tucson June 2015 - Present
The University of Arizona College of Nursing August 2013 - Present
The Writers Studio Tucson September 2012 - Present
SynCardia Systems, Inc. July 2007 - June 2013
Canyon Ranch September 2006 - June 2007
Arizona Daily Star April 2005 - December 2006
Arizona Daily Star June 2006 - August 2006
Skills
Press Releases, Patient Stories, Award Applications, Joomla, Vocus, Dreamweaver, Microsoft Excel, Microsoft Word, Outlook, Marketing Communications, Strategic Planning, Social Media, Facebook, Social Media Marketing, Editing, AP Style, Public Relations, Journalism, Marketing, Copywriting, Media Relations, Publicity, Storytelling, Newsletters, Writing
Education
University of Arizona 2003 — 2006
Bachelor's degree, Journalism, Summa Cum Laude
SynCardia Systems, Inc. February 2014 - Present
SynCardia Systems, Inc. July 2012 - Present
Securaplane June 2010 - June 2012
Raytheon Missile Systems June 2008 - April 2010
PSL 2005 - 2008
Skills
Solidworks, Pro Engineer, ANSYS, Geometric Dimensioning..., MRB, Corrective Actions, AutoCAD, Microsoft Office, Mechanical Engineering, GD&T, Finite Element Analysis, Tolerance Analysis, Manufacturing..., Cross-functional Team..., Engineering Management, Lean Manufacturing, Manufacturing, Engineering, Six Sigma, Design for Manufacturing, PTC Creo, SolidWorks, Design of Experiments
Education
New Mexico State University 2003 — 2008
Bachelor of Science (BS), Mechanical Engineering
Maricopa Community Colleges August 2015 - Present
Bank of America January 2011 - June 2015
SynCardia Systems, Inc. February 2009 - September 2009
ANALYZE INC. September 2002 - February 2008
ANALYZE INC. September 2000 - September 2002
NYPD April 1999 - September 1999
Schering-Plough October 1997 - April 1999
Skills
Management, Engineering, Consulting, Process Improvement, HPLC, Organic Chemistry, UV/Vis, GMP, Laboratory, FTIR, Analytical Chemistry, Analysis, Project Management, Cross-functional Team..., Business Analysis, Banking, Quality Assurance
Education
SUNY Stony Brook 1991 — 1996
Doctor of Philosophy (Ph.D.), Organic Chemistry
Northern Arizona University 1985 — 1988
Bachelor of Science (BS), Chemistry
Ventana Medical Systems January 2013 - Present
SynCardia Systems, Inc. July 2012 - January 2013
Crown Imports, LLC 2010 - 2012
Crown Imports, LLC January 2008 - December 2009
Crown Imports, LLC September 2005 - December 2007
Crown Imports Llc July 2004 - August 2005
Skills
Spectra, IRI, Shopper Marketing, Strategy, Key Account Development, Consumer Products, FMCG, Nielsen, Customer Insight
Education
Miami University 2000 — 2004
BS in Business Administration, Marketing
SynCardia Systems, Inc. 2011 - Present
SynCardia Systems 2010 - 2011
CardiacAssist,Inc 2002 - 2010
Skills
Medical Devices, FDA, Healthcare, Biomedical Engineering, ISO 13485, Clinical Research, Cardiology, Surgery, Clinical Trials, Operating Room, R&D, Market Development, Lifesciences, Product Launch, Surgeons, Biotechnology, Orthopedic, Design Control, Hospitals, Hardware Diagnostics, Capital Equipment, Regulatory Affairs
Education
New York University
MPA, Health Admin
Rutgers University
BA
SynCardia Systems, Inc. February 2014 - Present
SynCardia Systems 2008 - Present
Skills
FMEA, Product Marketing, Medical Devices, ISO 13485, Cross-functional Team..., Product Management, R&D, Marketing, Start-ups, Design Control, Continuous Improvement, Entrepreneurship, Market Development, Validation, FDA, Manufacturing, Management, Strategy, Cardiology, Commercialization, Solidworks, Lean Manufacturing, Product Development
Education
University of Arizona, Eller College of Management 2002 — 2006
B.S., Marketing and Entrepreneurship
SynCardia Systems, Inc. April 2012 - Present
Abiomed March 2011 - April 2012
CardiacAssist, Inc. August 2009 - April 2011
Bridgeport Hospital October 2007 - April 2008
Arrow International August 2006 - October 2007
EKOS Corporation April 2005 - June 2006
New Canaan volunteer ambulance 1983 - 2006
physiometrix 2001 - 2005
baxter 2001 - 2005
Skills
Clinical Research, Surgery, Capital Equipment, Interventional..., Clinical Trials, Medicine, Cardiology, Medical Devices, Hospitals, Operating Room, Healthcare, Critical Care, Cardiac Surgery
Education
University of Phoenix 1998 — 2000
BS, Business Management
Marymount University 1990 — 1992
AS, Nursing
SynCardia Systems, Inc. March 2015 - Present
SynCardia Systems January 2011 - March 2015
SynCardia Systems, Inc. January 2006 - June 2011
Old Pueblo Children's Services August 2005 - December 2005
Old Pueblo Children's Academy August 2003 - August 2005
Carolyn Grisko & Associates January 2001 - June 2003
Skills
Microsoft Office, Microsoft Excel, Forecasting, Account Reconciliation, Accounting, Maintenance Connection..., Expandable ERP Software, Office Management, Customer Service, Accounts Receivable, Medical Devices, Accounts Payable, Inventory Management, ERP, Manufacturing, Process Improvement, Cross-functional Team..., Strategic Planning, Budgets, General Ledger, Management, Product Development, FDA
Education
University of Phoenix 2009 — 2011
Bachelor, Business/Accounting Concentration
Pima Community College 2007 — 2009
Associates, Business Administration
SynCardia Systems, Inc. March 2012 - Present
Global Solar Energy, Inc. August 2010 - December 2011
Zygo Corporation July 2007 - August 2010
Texas Instruments / Burr-Brown Corporation March 2000 - November 2006
Delta V Technologies, Inc. April 1998 - February 2000
Skills
Program Management, Lean Manufacturing, Engineering, Project Management, Continuous Improvement, Cross-functional Team..., Manufacturing, Management, ISO, R&D, Solar Energy, Design of Experiments, Product Development, Project Planning, Thin Films, Process Improvement, Budgets, Manufacturing..., FDA, Six Sigma, Optics, Microsoft Office, Photovoltaics
Education
University of Phoenix 2004 — 2006
MBA, Technology Management
New York University - Polytechnic School of Engineering 1993 — 1995
Masters, Materials Engineering
Manhattan College 1983 — 1985
Ch.E., Chemical Engineering
Medtronic September 2012 - Present
Medtronic August 2011 - August 2012
SynCardia Systems, Inc. October 2009 - June 2011
Cardious September 2008 - September 2009
AEIOMed October 2006 - June 2008
Access Genetics May 2007 - October 2007
Skills
Design Control, FDA, V&V, Medical Devices, Biomedical Engineering, ISO 13485, Product Development, CE marking, R&D, Design of Experiments, Design for Manufacturing, Validation, FMEA, Biomaterials
Education
University of Minnesota-Twin Cities 2004 — 2009
BS, Biomedical Engineering
SynCardia Systems, Inc. March 2015 - Present
CannaPharmaRx February 2015 - Present
II-VI Incorporated November 2006 - Present
Nuron Biotech Inc April 2012 - December 2014
The Campbell Companies February 2012 - May 2012
Quench USA, Inc. July 2010 - February 2012
Globus Medical December 2008 - October 2009
Kensey Nash Corporation (now DSM) April 1996 - November 2008
Deloitte & Touche September 1990 - April 1996
Skills
Board Leadership, Financial Management, Audit Committee, IPO, SEC reporting, Medical Devices, CRO, Executive Management, Executive Reporting, Personnel Leadership, M&A due diligence, M&A experience, ERP, Biotechnology, Human Capital Management, Succession Planning, Executive Compensation, Strategy, Managerial Finance, Leadership, SEC filings, Executive Pay, Due Diligence, Investor Relations, Management, Mergers, Mergers & Acquisitions, Finance, Process Improvement, Auditing, Personnel Management, Business Strategy, Acquisition Integration, Sarbanes-Oxley Act, Start-ups, Private Sector, Public Speaking, Public Sector, Cash Flow Forecasting, Board Governance, Success Driven, Great Plains Software, Proxy Contests, Internal Controls, Public Companies, Revenue Recognition, Financial Analysis, Financial Reporting
Education
Philadelphia University 1987 — 1989
Bachelor of Science (BS), Accounting
University of Maryland College Park 1986 — 1987
Interior Design
The Catholic University of America 1985 — 1986
Accounting
SynCardia Systems, Inc. July 2013 - Present
Medtronic September 2010 - April 2013
Medtronic June 1996 - August 2010
Medtronic June 1983 - May 1996
Asea Brown Boveri (Pvt.) Ltd. June 1978 - March 1983
Skills
FDA, Medical Devices, Quality Assurance, Manufacturing, Product Development, Quality System, Continuous Improvement, Validation, Heart Valves, Engineering, Design for Manufacturing, Design of Experiments, Cross-functional Team..., FMEA, FDA GMP, Design Control, ISO 13485, V&V, ISO 14971, Software Documentation, Minitab
Education
University of St. Thomas 1992 — 1995
Mini-Masters, Manufacturing Systems
St. Cloud State University 1973 — 1978
B.S., Industrial Engineering, Computer Science
SynCardia Systems, Inc. October 2010 - Present
Syncardia Systems, Inc. May 2009 - October 2010
Cordis Neurovascular Inc. August 2003 - April 2009
Cordis, Johnson & Johnson August 2003 - April 2009
Skills
ISO 14971, ISO 13485, Medical Devices, Design Control, Quality System, Product Development, Lean Manufacturing, Quality Assurance, ISO, Manufacturing, FDA, SPC, Black Belt, Six Sigma, V&V, CAPA, Design of Experiments, Validation, Quality Control, Cross-functional Team..., GMP, FMEA, Supplier Quality, Root Cause Analysis
Education
Florida International University 2004 — 2006
MS, Engineering Management
Dore Residence- Progress Foundation May 2013 - Present
Desert Star Addiction Recovery Center June 2011 - February 2013
The University of Arizona April 2001 - February 2013
The Haven of Tucson August 2010 - December 2012
SynCardia Systems, Inc. May 2004 - September 2006
SynCardia Systems, Inc. April 2002 - September 2006
Skills
Addiction Recovery, Person Centered Planning, Motivational..., Empathy, Compassion, Crisis Intervention, Mental Health, Solution Focused, Community Outreach
Education
Arizona State University 2009 — 2012
Master's degree, School of Social Work
University of Arizona 2001 — 2004
Bachelor of Arts (B.A.), Physical and Biological Anthropology
University of Colorado Health January 2015 - Present
Pierce Wines Arizona 2005 - Present
PeaceHealth June 2014 - December 2014
Mayo Clinic College of Medicine July 2013 - June 2014
Mayo Clinic August 2011 - June 2014
SynCardia Systems, Inc. 2011 - 2013
Thoratec 2007 - 2013
Mayo Clinic June 2005 - August 2011
University Medical Center April 2004 - June 2005
University Medical Center January 1999 - June 2005
Skills
Clinical, Cardiac, Pediatrics, Clinical Trials, Inpatient, ICU, Surgery, Medical Devices, Product Development, Healthcare, Strategic Planning, Hospitals, Planning, Critical Care, Adults, Life Sciences, Treatment, Research, Team Building, Clinical Research, Health, Microsoft Office, Contract Negotiation, English, Business Strategy, Medical Education, Lifesciences, Project Planning, Ventricular Assist..., Perfusion, Cardiology, Healthcare Management, Cardiothoracic Surgery, Healthcare Information..., Informatics, ECMO, Cardiac Surgery, Medicine, Transplant, Heart Transplant
Education
University of Arizona 2002 — 2004
CP, Circulatory Sciences & Cardiovascular Perfusion
University of Arizona 2002 — 2004
MS, Pharmacology & Toxicology
University of Arizona 1997 — 2001
BS, Physiology
Jack Copeland, MD July 2014 - Present
SynCardia Systems, Inc. January 2002 - Present
UCSD Cardiovascular Center 2010 - 2014
The University of Arizona Health Network July 1977 - July 2010
The University of Arizona July 1977 - July 2010
Skills
Microsoft Excel, Medical Devices, Strategic Planning, Research, Healthcare Management, Team Building, Teaching, Healthcare, Budgets, Microsoft Office, Customer Service, Public Speaking, Clinical Research, Hospitals, Negotiation, Photoshop, Surgery, Outlook, Microsoft Word, Data Analysis, Medical Education, Healthcare Information..., Cardiology, Patient Safety, Clinical Trials, Critical Care, Nonprofits, Medicine, Fundraising, Transplant
Education
Stanford University School of Medicine 1964 — 1969
Doctor of Medicine (M.D.), AOA honnor society
Stanford University 1960 — 1964
Bachelor of Arts (B.A.), Biology, General
Delphinus Medical Technologies, Inc. June 2011 - Present
SynCardia Systems, Inc. October 2010 - December 2011
Terumo Cardiovascular Systems February 2006 - October 2010
Pall Life Sciences February 2002 - February 2006
Skills
ISO 13485, ISO 14971, 21 CFR Part 11, Risk Management, FMEA, 21 CFR Part 800, Biocompatibility, Quality System..., Quality Management, Supplier Quality, Medical Device Directive, REACH, RoHS, WEEE, Directive 2007/47/EC, Council Directive..., Council Directive..., FDA, Medical Devices, Design Control, V&V, CAPA, Software Verification, Software Validation, Project Management, Project Planning, 510(k), PMAs, IDE, Clinical Trials, Regulatory Affairs, Testing, Quality System, Validation, Product Development
Education
University of Michigan-Dearborn 2002 — 2005
Master of Environmental Science
University of Michigan-Dearborn 1993 — 1999
Bachelor of Science (B.S.), Biology
Compass Lexecon April 2011 - Present
SynCardia Systems, Inc. 2011 - 2011
Skills
Statistics, Econometrics, SAS, Stata, Statistical Modeling, Quantitative Analytics, Economics, Microeconomics, Macroeconomics
Education
University of Arizona, Eller College of Management 2006 — 2010
Bachelor's degree, Busines Economics
W. L. Gore & Associates August 2013 - Present
SynCardia Systems, Inc. November 2011 - August 2013
General Plasma Inc. December 2010 - November 2011
Vante May 2000 - November 2010
Skills
Solidworks, Engineering, Materials Science, Medical Devices, Total Artificial Heart, Mechanical Heart Valves, Wear/Durability in..., Catheter Manufacturing, Mechanical Engineering, Project Engineering, Thermoplastics, V & V Testing, Thermoforming, Vacuum Coating, Design for Manufacturing, Electronics Repair, Soldering, Manual Machining, Failure Investigation, Polymers, Metrology, ISO 13485, Machining, Failure Analysis, Testing, Design of Experiments, FDA, Manufacturing, Product Development, SolidWorks
Education
University of Arizona 2008 — 2010
M.S., Material Science and Engineering
University of Arizona 2005 — 2008
B.S., Mechanical Engineering
Hillsdale College 2003 — 2005
Pre-Engineering, Liberal Arts
SynCardia Systems, Inc. June 2014 - Present
SynCardia Systems, Inc. 2014 - Present
Skills
Microsoft Office, Product Development, Customer Service, Microsoft Excel, Medical Devices, Engineering, Microsoft Word, PowerPoint, Leadership
Education
Pima Community College 2012 — 2015
Bachelor of Arts (B.A.), English Language and Literature/Letters
University of Alaska Fairbanks 1982 — 1986
English Language and Literature/Letters
Skadden, Arps, Slate, Meagher & Flom LLP and Affiliates May 2015 - Present
Clean Energy Capital, LLC. September 2013 - March 2014
Trail Dust Town December 2012 - July 2013
NextMed May 2010 - September 2011
SynCardia Systems, Inc. May 2008 - September 2008
Skills
Mergers & Acquisitions, Corporate Finance, Due Diligence, Mediation, Oral Arguments, Contract Negotiation, Private Equity, Finance, Entrepreneurship, PowerPoint, Sales, Microsoft Excel, Team Leadership, Social Networking, Investments, Social Media, Written & Oral..., Project Management, Fundraising, Market Research, Philanthropy, Stunts, Presentations, Cross-functional Team..., Basic SQL, Basic Java Programming, Legal Contract Review, Corporate Governance, Research, Microsoft Office, Public Speaking, Leadership, Microsoft Word
Education
University of Southern California Gould School of Law 2014 — 2017
Doctor of Law (J.D.), Banking, Corporate, Finance, and Securities Law
University of Arizona, Eller College of Management 2010 — 2014
B.S.B.A., Management Information Systems, Finance, Entrepreneurship, Operations Management, Global Business
Ventana Medical Systems/Roche October 2013 - Present
ViaCyte (formerly Novocell) July 2013 - October 2013
SynCardia Systems, Inc. April 2013 - July 2013
Covidien May 2009 - September 2012
Medtronic Vascular 2009 - 2009
Siemens Medical Solutions, Oncology Care Systems June 2006 - October 2008
Siemens Medical Solutions June 2004 - August 2006
Siemens Medical Solutions March 2002 - June 2004
Agilent Technologies August 2000 - March 2002
Systron Donner Inertial Division October 1996 - August 2000
Skills
Product Development, Sensors, Systems Engineering, Design Control, FDA, Engineering Management, Agile, Theory of Constraints, Critical Chain Project..., Medical Devices, R&D, Quality Management, Electronics, Cross-functional Team..., ISO 13485, Process Simulation, Agile Methodologies, Testing, Validation, Design for Manufacturing, Continuous Improvement, Solidworks, Manufacturing, ISO 14971, Biomedical Engineering, SPC, Design of Experiments, Engineering, Embedded Systems, Product Lifecycle..., Six Sigma, Process Engineering, Quality System, CAPA, FMEA, Lean Manufacturing, Root Cause Analysis, V&V, Manufacturing..., Injection Molding, Product Design, Failure Analysis, DMAIC, Labview, Minitab, Pro Engineer, GD&T, Finite Element Analysis, Mechanical Engineering, ISO
Education
University of California, Los Angeles 1974 — 1976
MS
University of California, Los Angeles 1969 — 1974
BS
Ventana Medical Systems August 2013 - Present
SynCardia Systems, Inc. March 2013 - July 2013
The University of Arizona October 2010 - March 2013
Medipacs May 2007 - May 2010
Skills
Clinical Trials, Life Sciences, Immunohistochemistry, Biotechnology, Clinical Monitoring, Molecular Biology, Research, Immunology, Data Analysis, GCP, DNA, Lifesciences, eTMF
Education
University of Arizona 2009 — 2012
Professional Science Masters, Applied Bioscience
University of Arizona 2006 — 2008
Bachelor of Science (BS), Microbiology
SynCardia Systems, Inc. February 2014 - Present
SynCardia Systems, Inc. July 2012 - February 2014
Abbott Laboratories December 2010 - July 2012
Abbott Laboratories January 2009 - December 2010
Northwestern University August 2006 - January 2009
KCI Medical May 2005 - May 2006
Skills
Medical Devices, Project Management, Biomedical Engineering, Validation, Pharmaceutical Industry, Design Control, Statistical Data..., Technical Writing, User Requirements, Product Requirements, Human Factors, Risk Assessment, Product Development, Supplier Management, CAPA, Testing, FDA, Supply Management, R&D, Cross-functional Team...
Education
Northwestern University 2006 — 2008
Master of Science, Biomedical Engineering, GPA: 4.00/4.00
Trinity University 2002 — 2006
Bachelor of Science, Engineering Science, GPA: 3.96/4.00
Paragon Space Development Corporation April 2012 - April 2014
SynCardia Systems, Inc. October 2007 - February 2012
Embry-Riddle Aeronautical University April 2006 - August 2007
US Air Force October 1999 - December 2005
Skills
Procedure Development, Documentation, Aviation, Testing, Aircraft, Microsoft Office, Failure Analysis, Leadership, Software Documentation, Manufacturing, Medical Devices, Quality System, Air Force, Aircraft Maintenance, Aerospace, Troubleshooting, Root Cause Analysis, Process Improvement, Security Clearance, Quality Assurance, Avionics, Inspection, Program Management
Education
Embry-Riddle Aeronautical University-Worldwide 2014 — 2016
Master's Degree, Project Management
Embry-Riddle Aeronautical University 2007 — 2010
Technical Management, Management
Liberty High School
AstraZeneca April 2013 - Present
Abbott April 2011 - December 2012
SynCardia Systems, Inc. January 2010 - March 2011
SynCardia Systems, Inc. JAN January 2010 - March 2011
Applied Medical Resource Co. FEB January 2006 - October 2009
Enterprise Rent-a-Car AUG January 2002 - January 2006
Skills
Medical Devices, Sales, Operating Room Sales, Cardiology, Cardiothoracic Surgery, Urology, Process Improvement, International Sales, FDA, Selling, Surgeons, Product Launch, Clinical Research, Sales Operations, Hospitals, Operating Room, Healthcare, Pharmaceutical Sales
Education
University of Arizona 1998 — 2002
B.S, Psychology
Catalina Foothills High School 1994 — 1998
Yampa Precision May 2014 - Present
SynCardia Systems, Inc. July 2010 - November 2013
KLA-Tencor January 2006 - December 2008
ADE Phase Shift 1998 - December 2005
Skills
Manufacturing, ISO 13485, Medical Devices, Design Control, FDA, Engineering, Quality System, Design for Manufacturing, Semiconductors, Design of Experiments, Product Development, Continuous Improvement, Lean Manufacturing, Semiconductor Industry, R&D, Failure Analysis, Metrology, FMEA, Root Cause Analysis, Testing, Six Sigma, Manufacturing..., Cross-functional Team...
Education
APICS The Association for Operations Management 1999 — 2001
Completed All Required Courses for Certification, Production Planning and Execution
Tucson College 1986 — 1987
Computer Science
SynCardia Systems, Inc. March 2015 - Present
SynCardia Systems, Inc. November 2011 - Present
Mentor Worldwide, LLC, a Johnson & Johnson Company May 2008 - November 2011
Conceptus June 2007 - May 2008
Boston Scientific June 2000 - June 2007
Skills
Product Development, Medical Devices, New Business Development, Account Management, Operating Room, Capital Equipment, Business Development, Sales, Strategic Partnerships, Surgery, Sales Operations, Healthcare, Cardiology, Surgeons, Disposables, Product Launch, Cath Lab, Interventional..., Interventional Radiology
Education
Northern Illinois University
Bachelor of Science, Nursing
SynCardia Systems, Inc. November 2012 - Present
RAW:natural born artists June 2012 - December 2012
Herbalife January 2012 - January 2013
Altus Neurology December 2010 - July 2012
Chinese Box October 2010 - November 2010
Mandarin Grill June 2010 - November 2010
Capital Alarm August 2009 - December 2009
Skills
Medical Devices, Nutrition, Medical Terminology, Healthcare, Marketing, Problem Solving, Microsoft Word, Microsoft Excel, Medical Records, Operations Management, Time Management, Fitness Consulting, Accounts Receivable, Accounts Payable, Medical and Office..., Employee Payroll..., Banking, General Office..., Laboratory Skills, Report Writing Skills, Creative Writing, Inventory Optimization, Organizational Design, Organizational..., High Organizational...
Education
University of Arizona, College of Medicine 2005 — 2009
Physiology, Physiology
SynCardia Systems, Inc. January 2012 - Present
Digital Prodigy Computer Services, LLC March 2010 - August 2010
ATP 2008 - 2008
Education
University of Arizona 2011 — 2014
Electrical engineering, Engineering, Junior
Paradise Valley Community College 2005 — 2007
ABUS, Business
Delta Electronics Capital April 2011 - Present
Rocky Mountain Venture Capital Association July 2015 - Present
Blackstone Entrepreneurs Network Colorado April 2015 - Present
SynCardia Systems, Inc. February 2015 - Present
Wells Fargo / NREL Cleantech Innovation Incubator (IN2) October 2014 - Present
HZO July 2014 - Present
Satori Capital November 2010 - February 2011
SJF Ventures January 2010 - December 2010
Dunning Capital May 2010 - August 2010
Natural Capital Investment Fund October 2009 - March 2010
Skills
Cleantech, Renewable Energy, Venture Capital, Private Equity, Due Diligence, Financial Modeling, Valuation, Sustainability, Start-ups, Mergers & Acquisitions, Energy, Corporate Finance, Investments, Investment Banking, Leadership, Restructuring
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School
MBA, Sustainable Enterprise, Entrepreneurship
University of Colorado at Boulder - Leeds School of Business
BSBA, Finance, International Business
Danish Institute for Study Abroad
Economics, International Finance
SynCardia Systems, Inc. March 2015 - Present
SynCardia Systems, Inc. June 2014 - March 2015
The University of Arizona August 2013 - May 2014
The University of Arizona June 2013 - August 2013
The BIO5 Institute May 2012 - June 2013
Skills
Biomedical Engineering, Laboratory, Engineering, Manufacturing, Clean Rooms, Visual Basic, Microsoft Excel, Organization, Matlab, Microsoft Office, H&E staining, Biomechanics, Animal Models, Microsoft Word, Biomedical, Research, Clinical Research, ImageJ, Cancer, Optics, Science, Statistics
Education
University of Arizona 2010 — 2014
Bachelor of Science (BS), Biomedical Engineering, Senior
University of Arizona 2010 — 2014
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Johns Hopkins University December 2014 - Present
Johns Hopkins School of Medicine March 2014 - Present
Columbia University Medical Center February 2012 - February 2014
SynCardia Systems, Inc. 2012 - 2014
Skills
IRB, Clinical Trials, Clinical Research, FDA, Protocol, Regulatory Submissions, Research, Healthcare, Quality Assurance, Medical Devices, Patient Safety, Healthcare Management, Healthcare Information..., Cancer, Data Analysis, Hospitals, Public Health, Medicine, Medical Education, EMR, Critical Care, Nursing, Epidemiology, Surgery, Pediatrics, Oncology, Cardiology
Education
City University of New York-Hunter College 2007 — 2011
Bachelor of Arts (B.A.), Biochemistry, Political Science
Forest Hills High School 2003 — 2007
High School Diploma
Forest Hills High School
SynCardia Systems, Inc. August 2015 - Present
SynCardia Systems, Inc. July 2012 - August 2015
The University of Arizona August 2007 - May 2012
University of Sassari June 2010 - 2011
Skills
Teaching, Tutoring, Laboratory Skills, Italian, Manufacturing, Research, Cell Culture, Laboratory, Bacterial Culture, Protein Purification, Microbiology, Molecular Cloning, Protein Chemistry, Fluorescence Microscopy, Molecular Biology, Data Analysis, Western Blotting, Biochemistry, PCR, FDA, Medical Devices, GMP, GLP
Education
University of Arizona, Eller College of Management 2015 — 2016
Master of Business Administration (M.B.A.)
University of Arizona 2007 — 2012
Bachelor’s Degree, Molecular and Cellular Biology, Biochemistry and Molecular Biophysics
Aflac November 2013 - Present
SynCardia Systems, Inc. January 2013 - July 2013
SynCardia Systems, Inc. January 2011 - December 2012
SynCardia Systems, Inc. January 2009 - January 2011
Skills
Manufacturing, Medical Devices, FDA, Quality System, Quality Assurance, Continuous Improvement, Leadership, Product Development, Marketing, CAPA, Hands-on Training, Sales, Sales Presentations, Cold Calling Experience, Building Relationships, Supplemental Health, Voluntary Employee..., Goal Setting, Personal Development, Training, Cold Calling
Education
University of Arizona 2004 — 2008
Bachelor of Arts in Behavioral and Social Science, History with a Minor in Sociology
Monash University
History
Raytheon November 2012 - Present
BAE Systems May 2011 - June 2012
SynCardia Systems, Inc. February 2011 - April 2011
Raytheon Missile Systems May 2007 - April 2010
Raytheon September 2005 - May 2007
BAE Systems September 2004 - September 2005
MBDA January 2002 - September 2004
Boeing November 2000 - July 2001
Boeing October 1998 - November 2000
University of Wisconsin-Madison February 1998 - May 1998
Skills
Engineering, Pro Engineer, Systems Engineering, Testing, Integration, Matlab, Requirements Analysis, C++, Simulations, Fortran, Linux, System Design, Aerospace, Six Sigma, Defense, Engineering Management, Requirements Management
Education
University of Wisconsin-Madison 1996 — 1998
MS, Mechanical Engineering
California Polytechnic State University-San Luis Obispo 1990 — 1995
BS, Mechanical Engineering
Dos Pueblos High School 1986 — 1990
High School, General Studies
Southern Methodist University
Master’s Degree, Data Science
SynCardia Systems, Inc. June 2015 - August 2015
City of Tucson Parks and Recreation June 2011 - August 2014
Skills
Matlab, SolidWorks, LabVIEW, Microsoft Office, Microsoft Word, PowerPoint, English, Home Remodeling
Education
Colorado School of Mines 2013 — 2017
B.S, Mechanical Engineering
CardiacAssist, Inc. February 2014 - Present
SynCardia Systems, Inc. January 2012 - July 2013
Skills
Medical Devices, Capital Equipment, Cardiology, Hospitals, Diagnostics, Cardiac Surgery, Cardiac EP/Cath Lab, Hospital Senior..., Hardware Diagnostics, Surgery, Laboratory, Market Development, Operating Room, Product Launch, Surgeons, Vascular, Disposables, Interventional..., Surgical Instruments
Education
Penn State University
Bachelor of Science
Proven Process Medical Devices April 2013 - Present
Proven Process Medical Devices April 2009 - April 2013
SynCardia Systems, Inc. November 2004 - March 2009
Ventana Medical Systems November 2003 - October 2004
Ortho Clinical Diagnostics September 1995 - October 2003
Johnson and Johnson 1995 - 2003
Skills
Design Control, FDA, ISO 13485, Medical Devices, CAPA, Quality System, V&V, Validation, ISO, Six Sigma, 21 CFR Part 11, ISO 14971, Design of Experiments, Regulatory Submissions, Quality Assurance, Change Control, Product Development, Injection Molding, FMEA, Manufacturing, Regulatory Affairs, Minitab, R&D, Iso 9000, Root Cause Analysis, DMAIC, Quality Auditing, PMA, Design for Manufacturing
Education
Rochester Institute of Technology 1997 — 2001
MBA, Quality Management, Quality and Applied Statistics
Niagara University 1991 — 1995
BS, Biology, Chemistry minor
SynCardia Systems, Inc. July 2009 - Present
Cordis Johnson & Johnson June 2005 - December 2008
University of Miami/ Jackson Memorial Hospital January 2004 - May 2005
Florida International University May 2001 - November 2002
Skills
Design Control, Pro Engineer, Design of Experiments, Medical Devices, FDA, Validation
Education
University of Miami 2003 — 2005
MS, Biomedical Engineering
Florida International University 1999 — 2003
BS, Mechanical Engineering
shopOrganic January 2008 - Present
SynCardia Systems, Inc. April 2006 - May 2007
ShopNatural Cooperative May 2003 - April 2006
Skills
Product Development, Food, Entrepreneurship, Online Marketing, Social Media, Marketing Strategy, Start-ups, Marketing, Brand Development, Email Marketing, E-commerce, Marketing Management
Education
Rutgers University-New Brunswick 1990 — 1993
SynCardia Systems, Inc. March 2010 - Present
LUX Aviation October 2006 - February 2010
Securaplane Technologies, Inc. April 1997 - September 2006
Skills
Engineering, Product Development, Medical Devices, Solidworks, Batteries, Continuous Improvement, Cross-functional Team..., Design for Manufacturing, Engineering Management, FMEA, Injection Molding, Lean Manufacturing, Manufacturing, Mechanical Engineering, Quality System, R, Root Cause Analysis
Education
University of Arizona 1993 — 1997
Bachelor's degree, Mechanical Engineering
HeartWare Inc March 2013 - Present
HeartWare Inc September 2011 - March 2013
SynCardia Systems, Inc. January 2008 - September 2011
University of California, Irvine May 2003 - June 2007
International Beauty Design, Inc. August 2001 - February 2003
International Beauty Design, Inc. August 2000 - August 2001
Skills
Clinical Research, Cardiovascular Disease, Diabetes, Hospitals, Research, Medical Devices, Medical Education, Operating Room, Cardiology, FDA, Interventional..., Small Business, Entrepreneurship, Cross-functional Team..., Quality System, Clinical Trials, Knowledge Transfer, Analysis, Mechanical Circulatory..., Surgery, Medicine
Education
Harvard Medical School 1999 — 2000
Postdoctoral Fellow
University of Arizona 1995 — 1999
Ph.D.
University of Arizona 1993 — 1995
M.S.
California State University-Long Beach 1987 — 1993
B.S.
Eller Professional Sales Club June 2013 - Present
Eller College of Management, University of Arizona May 2012 - Present
New View Group, LLC January 2003 - Present
Inside Tucson Business January 2010 - September 2013
Tucson Hispanic Chamber of Commerce 2007 - 2012
Financial Executives and Affiliates of Tucson 2009 - 2011
AMIT 2007 - 2008
SynCardia Systems, Inc. 2001 - 2002
Compaq Computers / Hewlett Packard January 1998 - January 2001
Intuit 1996 - 1999
Skills
Advertising, Volunteer Management, Public Speaking, Sales Process, Social Media, Management, Press Releases, Public Relations, Social Media Marketing, Fundraising, B2B, Social Networking, Coaching, Entrepreneurship, Marketing, Training, Marketing Communications, Strategic Planning, Strategic Partnerships, Leadership Development, Marketing Strategy, Media Relations, Online Advertising, Budgets, Negotiation, Recruiting, Leadership, Nonprofits, Online Marketing, Business Planning, Strategy, Time Management, Direct Sales, Event Planning, Start-ups, Customer Service, Team Leadership, New Business Development, Business Development, Product Development, Market Research, Facebook
Education
Stanford University Graduate School of Business 1976 — 1978
MBA, Finance, Marketing
Stanford University 1972 — 1974
BA, History
Defense Language Institute 1969 — 1970
Russian Language
Princeton University 1965 — 1967
Russian / Soviet Studies
Haverford School
Haverford School
Haverford School
University of Arizona, Eller College of Management
SynCardia Systems, Inc. March 2015 - Present
Myriad RBM, Inc. January 2011 - March 2015
Rules Based Medicine December 2009 - January 2011
Bridgepoint Consulting, LLC October 2009 - January 2010
ImaRx Therapeutics October 2007 - September 2009
Resources Global Professionals September 2007 - October 2007
Vaco 2006 - 2007
Wireless Facilties Inc March 2005 - July 2006
Anacomp September 2004 - January 2005
ASRC Energy Services November 2001 - September 2004
Skills
Financial Reporting, SEC filings, GAAP, Sarbanes-Oxley Act, US GAAP, Budgets, Internal Controls, Accounting, Auditing, Strategic Financial..., Project Management, Oracle Applications, Financial Analysis, Financial Accounting, Cash Management, Account Reconciliation, General Ledger, Financial Statements, Planning, Project Planning, Finance, Internal Audit, Sarbanes-Oxley, Forecasting, SEC reporting, Software Implementation, Financial Planning, Consolidation, Process Improvement, XBRL, Leadership, Inventory Accounting, Mergers & Acquisitions, Due Diligence, IPO, Prophix, Revenue Recognition, Staff Development, Covenant Compliance, Leases, Divestitures, Hyperion Reports, FRx Report Writer, Great Plains Software, JD Edwards, SOX 404, Income Tax, Biotechnology, SEC Filings
Education
Arizona State University 1993 — 1997
Bachelor of Science, Accountancy
Modular Mining Systems August 2013 - Present
SynCardia Systems, Inc. July 2012 - April 2013
The University of Arizona Health Network January 2010 - June 2012
Pacific Coast Feather Company January 2007 - January 2010
lisa frank inc December 2005 - October 2006
lisa frank, inc 2005 - 2006
Lisa Frank,Inc. 2005 - 2006
Skills
Financial Statements, Accounting, General Ledger, Fixed Assets, Financial Reporting, Accounts Receivable, Accounts Payable, Auditing, Finance, Accruals, Journal Entries, Account Reconciliation, Analysis, Cash Management, GAAP, Payroll
Education
Central Washington University 2003 — 2006
Bachelor of Applied Science (B.A.Sc.), Accounting
Central Washington University 2002 — 2005
Bachelors, Accounting
South Seattle Community College 2001 — 2002
Associate of Arts (A.A.), Business Administration and Management, General
W. L. Gore & Associates December 2012 - Present
SynCardia Systems, Inc. May 2011 - June 2012
Raytheon Missile Systems May 2006 - May 2011
Advanced Ceramics Research Inc May 2004 - May 2006
Skills
Solidworks, Manufacturing, Engineering, Design for Manufacturing, Pro Engineer, Medical Devices, Product Development, Six Sigma, Failure Analysis, Testing, Materials Science, Machine Tools, Mechanical Engineering, Engineering Management, FDA
Education
University of Arizona, Eller College of Management 2007 — 2009
MBA, Business Administration
University of Arizona 1998 — 2004
BSME, Mechanical Engineering
SynCardia Systems, Inc. March 2012 - Present
AuroraPath Advisors November 2009 - March 2012
Zygo Corporation June 2007 - November 2009
Optical Research Associates 2001 - 2007
Exatec, LLC 1997 - 2000
General Electric 1977 - 2000
Skills
Manufacturing, Medical Devices, Product Development, Optics, Plastics, Polymers, Product Marketing, New Business Development, Business Strategy, Automotive, R&D, Strategy, Engineering, Business Development, Leadership, Strategic Planning, Cross-functional Team..., Entrepreneurship, Product Launch, Lifesciences, Commercialization, Start-ups, Management, FDA, ISO 13485, Mergers & Acquisitions, Market Development, Semiconductors, Six Sigma, Design for Manufacturing, Product Management, Design of Experiments, Lean Manufacturing, Continuous Improvement, Quality System, Sensors, Engineering Management, Biomedical Engineering, Materials Science, Design Control, Materials, Process Engineering, FMEA
Education
Massachusetts Institute of Technology 1972 — 1975
S.B., Physics
SynCardia Systems, Inc. February 2013 - Present
SynCardia Systems, Inc. August 2011 - January 2013
Vascular Solutions January 2009 - August 2011
Polar Tank Trailer October 2005 - January 2009
Talon Innovation January 2005 - May 2005
St. Cloud State University September 2002 - December 2004
Integrated Development Consultancy May 2001 - July 2002
Skills
ISO 14971, IEC 60601, CAPA, Design Control, Root Cause Analysis, ISO 13485, Risk Management, FMEA, Six Sigma, SPC, Quality System, Minitab, Design of Experiments, FDA, Continuous Improvement, Lean Manufacturing
Education
St. Cloud State University 2002 — 2005
Masters, Mechanical Engineering
Tribhuvan Vishwavidalaya
University of Arizona Psychiatry April 2013 - Present
SynCardia Systems, Inc. September 2011 - July 2012
University of Arizona Human Subjects Protection Program May 2009 - June 2011
Arizona Cancer Center August 2008 - June 2009
Citi Mortgage January 2009 - May 2009
Southern Arizona Legal Aid (SALA) August 2008 - January 2009
GEICO January 2007 - November 2008
Arizona Cancer Center April 2004 - December 2006
University Medical Center March 2004 - March 2005
APAC Customer Service May 2002 - March 2004
Skills
Management, Team Leadership, Leadership, Research, Clinical Research, Molecular Biology, Cell Biology, Biochemistry, Manufacturing, Economics, Finance, Marketing, Advertising, MIS, Communication, Medical Devices, IRB, FDA, Negotiation, HIPAA, Production, Social Media Marketing
Education
University of Arizona Eller Evening MBA Program 2012 — 2013
Masters of Business Administration, MBA, Business
University of Arizona 2002 — 2006
Bachelors of Science, Cell/Cellular and Molecular Biology
University High School 1998 — 2002
SynCardia Systems, Inc. August 2013 - Present
SynCardia Systems, Inc. December 2005 - August 2013
SynCardia Systems, Inc. December 2004 - December 2005
J.G. Van Holten & Son, Inc September 2001 - December 2004
Skills
Medical Devices, Venture Capital, Forecasting, Manufacturing, Financial Reporting, Risk Management, Accounting, Mergers, FDA, Entrepreneurship, Mergers & Acquisitions, Cost Accounting, Management, Budgets, Process Improvement, Payroll, Financial Audits, Finance
Education
University of Minnesota Law School 1989 — 1992
JD, Law
Minnesota State University, Moorhead 1985 — 1989
BS, Accounting
SynCardia Systems, Inc. November 2012 - Present
N/A August 2012 - November 2012
Starwood Hotels & Resorts Worldwide, Inc. June 2011 - August 2012
Starwood Hotels & Resorts Worldwide, Inc. June 2008 - June 2011
Lazboy Furniture Galleries September 1999 - January 2008
Tucson Newspapers July 1998 - July 1999
Skills
PCI DSS, SOX Compliancy, QSA, Cisco Technologies, Microsoft Windows (all..., Microsoft Server..., Wired Networking, Wireless Networking, Microsoft Office, Hospitality Solutions..., Timelox Hospitality Key..., Mac OS, Scriptlogic Desktop..., Active Directory, Network Administration, DHCP, Powershell, Delphi, Citrix, Networking, POS, Hospitality, Technical Support, Management, Windows, System Administration, IT Operations, Symantec Endpoint..., Microsoft Exchange, Windows Server, IT Management, VPN, Disaster Recovery, Servers, Troubleshooting
Education
University of Arizona 1986 — 1997
BA, German/Mathematics/MIS/Political Science
SynCardia Systems, Inc. September 2012 - Present
Skills
Design Control, ISO 13485, Design for Manufacturing, Medical Devices, ISO 14971, Quality System, CAPA, FDA, R&D, Failure Analysis, Quality Management, Manufacturing, Solidworks, Lean Manufacturing, Engineering Management, Product Development, Cross-functional Team..., Engineering, Electronics, Semiconductors
Education
Boston University 1981 — 1985
BSEE
Artcraft Promotional Concepts November 2011 - Present
SynCardia Systems, Inc. 2008 - 2010
Education
Indiana University of Pennsylvania 2003 — 2006
Grove City High School 1999 — 2003
High School