Sunshine Heart, Inc
Industry: Company
DescriptionHeadquarters: Eden Prairie, MN Founded: 1999 Subsidiary: Sunshine Heart Company Pty Ltd.
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Sunshine Heart, Inc Employees
Sunshine Heart, Inc November 2014 - Present
Medtronic Vascular August 2013 - November 2014
Cordis February 2010 - March 2011
Maquet Getinge Group November 2005 - February 2010
Boehringer Ingelheim February 2002 - October 2005
Edwards Lifesciences November 1995 - February 2002
Skills
Medical Devices, Cardiology, Operating Room, Capital Equipment, Pharmaceutical Sales, Interventional..., Surgeons, Sales Operations, Surgical Instruments, Vascular, Disposables, Cath Lab, Market Development, Surgery, Vascular Surgery, Hospitals, Interventional Radiology, Cardiac Surgery
Education
Christ Hospital School of Perfusion Science
Certiication in Clinical Perfusion, Cardiac Perufsion
Shippensburg University of Pennsylvania
B.A., Communications/Public Relations
Sunshine Heart, Inc April 2014 - Present
Private Consulting January 2009 - 2014
Westchester Elementary School 1987 - 1988
Sea World May 1985 - 1988
Skills
Event Management, Educational Leadership, Personal Development, Teacher Training, Teaching, Performance Measurement
Education
Concordia College 1983 — 1987
Bachelor of Arts Degree, Elementary Education and Teaching
UNIVERSITY OF MINNESOTA
Sunshine Heart, Inc January 2015 - Present
Danfoss Power Solutions March 2014 - January 2015
Medtronic August 2006 - January 2014
Boston Scientific January 2003 - July 2006
Boston Scientific 1993 - 2003
Boston Scientific 1990 - 1993
Carl Zeiss Metrology 1987 - 1990
Skills
Biomedical Engineering, ISO 13485, Embedded Software, Firmware, Embedded Systems, Design Control, Medical Devices, FDA, Software Engineering, R&D, Systems Engineering, Labview, Debugging, Device Drivers, Digital Signal..., C++, Testing
Education
University of St. Thomas 1989 — 1997
Master's degree
St. John's University
Bachelor of Science (BS)
HeartWare Inc August 2014 - Present
Sunshine Heart, Inc September 2011 - August 2014
Medtronic May 2008 - September 2011
Medtronic January 2005 - April 2008
Medtronic March 2003 - December 2004
Genzyme January 2000 - March 2003
Boston Scientific January 1992 - January 2000
Unilever January 1989 - January 1992
Procter & Gamble December 1984 - January 1989
Skills
Global Marketing, Marketing Strategy, Sales Management, Product Management, Market Development, Medical Devices, Competitive Analysis, Product Development, Strategy, Leadership, Management, Market Planning, Marketing, Marketing Management, P, Pricing, Product Launch, Sales, Product Marketing, Start-ups, Strategic Planning, Business Strategy, Cardiology, Commercialization, Cross-functional Team..., Healthcare, International Sales, Coaching
Education
Northeastern University - Graduate School of Business Administration 1997 — 1999
MBA, Business
University of Delaware 1980 — 1984
BSBA, Business Administration
CPA Global August 2014 - Present
Dykema Gossett PLLC August 2013 - July 2014
Sunshine Heart, Inc January 2013 - July 2013
Merchant & Gould P.C. November 2012 - January 2013
Fish & Richardson P.C. February 2012 - October 2012
Faegre Baker Daniels LLP 2005 - 2012
Education
Minnesota School of Business 2004 — 2005
Associates Degree, Paralegal
Iowa State University 1999 — 2003
BA, Sociology
Sunshine Heart, Inc May 2012 - Present
Applebee's July 2011 - April 2013
Visible Heart Laboratory August 2011 - May 2012
Massage Envy June 2009 - July 2011
University of Wisconsin-River Falls May 2009 - September 2009
Blaine High School January 2007 - April 2007
Skills
Detail Oriented, Laboratory Notebooks, Laboratory Safety, Microsoft Office, MIMICs, MS Project, Problem Solving, Project Management, Reliability, Self-directed, Team Leadership, Teamwork, Time Management, OsiriX, Biomedical Engineering, IEC 60601-1, Six Sigma, Cardiac, IEC 60601, Medical Devices, R&D, Microsoft Excel
Education
University of Minnesota-Twin Cities 2010 — 2012
Bachelor of Biomedical Engineering, emphasis in Medical Devices
University of Wisconsin-River Falls 2007 — 2010
Bachelor of Science, Physics
Blaine High School
Sunshine Heart, Inc September 2015 - Present
Sunshine Heart, Inc September 2011 - September 2015
Jarvik Heart Inc June 2009 - August 2011
Botswana Butchery December 2007 - November 2008
Sunshine Heart Company October 2007 - December 2007
Dream Engineering November 2006 - April 2007
General Motors May 2006 - August 2006
Skills
Product Development, Project Planning, Manufacturing, Automotive, Matlab, Design Engineering, Medical Devices, Quality System, Biomedical Engineering, R&D, Design Control, CAPA, ISO 13485, FDA, Testing, Design for Manufacturing, Mechanical Engineering
Education
Lehigh University 2003 — 2007
BS, Mechanical Engineering
Purdue University 2012 — 2015
Master's, Biomedical/Medical Engineering
General Dynamics Mission Systems August 2015 - Present
Sunshine Heart, Inc August 2013 - July 2015
General Dynamics C4 Systems September 2003 - July 2011
kingdom Sound and Lighting April 2001 - April 2003
Electronics for Imaging August 1998 - March 2001
General Dynamics AIS 1981 - 1999
Skills
Testing, Test Equipment, Engineering, Troubleshooting, Manufacturing, Configuration Management, Integration, Systems Engineering, Engineering Management, Software Documentation, Security Clearance, Embedded Software, Avionics, ESD control, Debugging, Field Service, Software Engineering, Electronics, Program Management, Failure Analysis, DoD, Customer Support, Earned Value Management, System Design, Telelogic DOORS, Aerospace, System Testing, Sensors, Embedded Systems
Education
North Dakota State College of Science
Associate of Science, Electronic Technology
The University of North Dakota
2 years, Electrical Engineering
Sunshine Heart, Inc November 2014 - Present
Sunshine Heart, Inc June 2014 - November 2014
DesignWise Medical January 2014 - June 2014
University of Minnesota December 2013 - June 2014
CUBIC Visual Systems June 2012 - December 2013
St. John's University September 2010 - May 2012
Mayo Clinic May 2011 - August 2011
Skills
Matlab, Microsoft Office, R, Minitab, Mechanics, Pro Engineer
Education
University of Minnesota-Twin Cities 2012 — 2014
BS, Biomedical Engineering
St. John's University 2008 — 2012
BA, Natural Sciences
Sunshine Heart, Inc November 2013 - Present
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Research, Photoshop, English, Outlook, Windows, HTML, Team Leadership, Event Management, Social Media Marketing, Interpersonal..., Interviews, Time Management, Training, Human Resources
Education
The University of North Dakota 2007 — 2011
Business/Corporate Communications
Ridgewater College 2012 — 2012
Sunshine Heart, Inc November 2011 - Present
Johnson Family July 2010 - Present
Andersen Windows July 2007 - July 2010
Andersen Corp 2003 - 2007
Andersen Corp May 2006 - July 2006
Skills
Manufacturing..., Lean Manufacturing, DMAIC
Education
University of Minnesota Duluth 1999 — 2003
BSIE, Industrial Engineering Automated Systems
Wadena
Devicix - A Division of Nortech Systems, Inc. June 2015 - Present
Sunshine Heart, Inc January 2012 - June 2015
Minnetronix, Inc. February 2010 - December 2011
CareFusion May 2009 - January 2010
Smiths Medical October 2008 - July 2009
Minnetronix, Inc. March 2006 - September 2008
Lockheed Martin May 2003 - December 2005
NASA, Trane Company, United Defense May 1996 - April 2003
Skills
Embedded Software, Software Design, Medical Devices, Design Control, R&D, Product Development, FDA, Embedded Systems, ISO 13485, Firmware, Engineering, Systems Engineering, IEC 62304, Product Management, Cross-functional Team..., Embedded Communications, Embedded RTOS, Embedded C++, Risk Management, RTOS, Software Development, Multithreading, Engineering Management, Debugging, Digital Signal..., OOAD, Testing, Signal Processing, Microcontrollers, ARM, Device Drivers, I2C, System Architecture, Software Engineering, Embedded C, QNX, SPI, Embedded Operating..., Sensors, RS232, C++, Electronics, C, Project Management, Quality System
Education
St. Cloud State University
BS, Electrical Engineering
Logic PD October 2014 - Present
Sunshine Heart, Inc January 2014 - October 2014
Sunshine Heart, Inc February 2012 - December 2013
Sunshine Heart, Inc August 2011 - February 2012
Medtronic September 2005 - October 2011
Redline Performance Products, LLC April 2005 - September 2005
Bobcat Company January 2004 - August 2005
Best Buy May 2002 - December 2003
Skills
Product Development, Medical Devices, Cross-functional Team..., Six Sigma, Project Management, Data Analysis, Process Improvement, Team Leadership, Manufacturing, Microsoft Office, Microsoft Excel, Leadership, Start-ups, Minitab, R&D, Lean Manufacturing, Biomedical Engineering, Testing
Education
North Dakota State University 1999 — 2005
Bachelor's Degree, Electrical Engineering; Biomedical Engineering
North Dakota State College of Science 2000 — 2002
Associate's Degree, Business Management
Sunshine Heart, Inc 2011 - 2015
Zareba Systems, Inc. 2005 - 2010
Delphax Technologies, Inc. 2004 - 2005
TMG, Inc. 2003 - 2004
Micro Component Technology, Inc. 1996 - 2003
Recovery Engineering, Inc. / PUR [Proctor & Gamble] 1991 - 1996
Osmonics Inc. [General Electric Corporation] 1988 - 1991
Aslesens, Inc. 1987 - 1988
Deloitte & Touche, LLP 1983 - 1987
Skills
IPO, Strategic Planning, Mergers & Acquisitions, Due Diligence, SEC filings, Finance, Analysis, Product Development, Risk Management, Divestitures, Management, Auditing, Mergers, Financial Reporting, Managerial Finance, Financial Analysis, Process Improvement, Accounting, SEC Filings
Education
The University of South Dakota 1979 — 1983
BS/BA, Accounting
MyLVAD September 2011 - Present
Innovative Program Solutions, LLC May 2008 - Present
Sunshine Heart, Inc 2011 - 2014
Penn State Milton S. Hershey Medical Center September 1997 - May 2008
Skills
Healthcare, Hospitals, Clinical Research, Critical Care, Nursing, Clinical Trials, Medical Devices, Healthcare Management, Healthcare Information..., Cardiology, ICU, EMR, Surgery, Medicine, Patient Safety, Medical Education, Acute Care, Clinical Development, Biomedical Engineering, Biotechnology, Regulatory Affairs, Lifesciences, Public Health, Internal Medicine, Cardiac Surgery
Education
Penn State University 1995 — 1997
MS, Nursing
Temple University 1988 — 1992
BSN, Nursing
Sunshine Heart, Inc November 2014 - Present
Abiomed March 2008 - August 2013
Abbott Vascular February 2003 - November 2007
Guidant September 2002 - November 2007
Skills
Lifesciences, Interventional..., Capital Equipment, Vascular, Medical Devices, Cath Lab, Cardiology, Market Development, Operating Room, Healthcare, Disposables, Hospitals, Interventional Radiology, Surgeons, Product Launch, Clinical Research
Education
Minnesota State University, Moorhead 1987 — 1991
BA, Psychology
wahpeton senior high
Sunshine Heart, Inc September 2014 - Present
Mainstay Medical July 2013 - August 2014
Mainstay Medical February 2013 - July 2013
Medtronic April 2010 - February 2013
Leptos Biomedical July 2008 - March 2010
Boston Scientific, CRM February 2006 - May 2008
Boston Scientific, CRM February 2003 - January 2006
Skills
FDA Pre-IDE Negotiation, FDA PMA Negotiation, FDA Panel, Manuscript Development, Investigator Training, Post-Approval Study..., IDE Study Development, IDE Study Execution, PMA Report Development, IDE Study Closure, Informed Consent..., Trial Budget, Clinical Strategy, Site Selections, Core Lab Management, CRO Management, BIMO Audit, Medical Devices, FDA, CRO, Clinical Trials, CTMS, Cardiology, Clinical Research, Design Control, Biomedical Engineering, ISO 13485, Regulatory Submissions, Clinical Development, Clinical Operations, GCP, Regulatory Affairs, R, CAPA
Education
The College of St. Scholastica
MA, Exercise Physiology
Sunshine Heart, Inc December 2011 - Present
Cenveo Inc August 2010 - December 2011
Zareba Systems, Inc. May 2006 - September 2010
Compex Technologies Inc May 1998 - May 2006
Sunrise Resources Inc May 1996 - May 1998
Merrill Corporation July 1986 - May 1996
Van Dusen Air Inc November 1982 - July 1986
Arthur Andersen & Co July 1979 - November 1982
Skills
SOX, Financial Analysis, Financial Reporting, Financial Accounting, Manufacturing, Mergers, SEC reporting, Cost Accounting, General Ledger, Managerial Finance, Finance, Internal Controls, Mergers, Revenue Recognition, SEC filings, Sarbanes-Oxley, Sarbanes-Oxley Act, US GAAP, Forecasting, Process Improvement
Education
Saint John's University 1975 — 1979
B.S.- Accounting, Accounting
Sunshine Heart, Inc November 2014 - Present
CVRx November 2011 - November 2014
CVRx June 2007 - October 2011
CVRx 2007 - 2008
Johns Hopkins Hospital 2001 - 2003
Skills
Biomedical Engineering, Electrophysiology, Clinical Research, Medical Devices, Clinical Trials, Biotechnology, Lifesciences, Neuroscience, Surgery, Animal Models, Healthcare, Clinical Development, Cardiovascular..., Pressure Volume Loops, Hemodynamics, Baroreceptor Physiology, Baroreflex, Systems Physiology, Physiology, Cardiology, FDA, Interventional..., Heart Failure, Medical Device R, PMA, Medical Research, Neuromodulation, Medical Education, CRO, R&D, ISO 13485, Product Launch, Commercialization, Biomaterials, Medical Device R&D, CAPA, V&V, Design of Experiments, ISO 14971, Validation, Life Sciences, Cross-functional Team...
Education
Johns Hopkins Bloomberg School of Public Health 1994 — 2001
PhD, Systems Physiology, Cardiology, Biomedical Engineering
University of Toronto 1991 — 1992
Bachelor of Education (B.Ed.), Mathematics and Science (High School), Honours Distinction
University of Toronto 1984 — 1988
B.Sc. (Hons), Systems Physiology and Physics
Sunshine Heart, Inc April 2014 - Present
nContact, Inc. August 2013 - April 2014
St. Jude Medical August 2008 - August 2013
St. Jude Medical April 2007 - August 2008
St. Jude Medical July 2006 - April 2007
Impulse Dynamics August 2004 - July 2006
BIOTRONIK September 2002 - August 2004
Medtronic May 1999 - September 2002
Skills
Sales, Medical Devices, Cardiology, Clinical Trials, Cardiac Rhythm..., Operating Room, Field Clinical..., Heart Failure, Networking, Building Relationships, Training and Education, Arrhythmias, Kettlebells, Fitness, Krav Maga, Sandbag Training, Self Defense, CrossFit, Atrial Fibrillation, EP Lab, HRS, LinkedIn, PDR Fundamentals, Biologics, Cath Lab, Pacemakers, Surgeons, Sales Effectiveness, Surgical Instruments, Diabetes, Healthcare, Surgery, Catheters, Hospitals, Electrophysiology, Spine, Leadership, Sales Operations, Medical Sales, Urology, Cold Calling, Interventional..., Clinical Research, Disposables, Capital Equipment, Neurology, Cardiac Surgery, Product Launch, Pharmaceutical Sales, Orthopedic
Education
Rutgers, The State University of New Jersey-New Brunswick 1997 — 1999
MS program, Biomedical Engineering, Biomechanics and Biomaterials
Rutgers, The State University of New Jersey-Camden
Bachelors, Biological Sciences
Sunshine Heart, Inc June 2015 - Present
Hill-Rom Respiratory Care February 2013 - June 2015
Altermatt Consulting September 2012 - January 2013
St. Jude Medical 2007 - 2012
St. Jude Medical, Cardiology Division 2004 - 2007
St. Jude Medical 2001 - 2003
St. Jude Medical 2000 - 2001
Instrumentation Laboratory 1998 - 2000
Instrumentation Laboratory 1995 - 1998
Instrumentation Laboratory 1987 - 1994
Skills
Medical Devices, Interventional..., Vascular, Cross-functional Team..., Clinical Research, Product Development, Electrophysiology, Market Development, Capital Equipment, Product Launch, Operating Room, Disposables, Marketing Strategy, Long-term Customer..., Strategic Planning, Cardiology, Lifesciences, ISO 13485, Validation, FDA, Global Marketing, Product Marketing, Interventional Radiology, Commercialization, Surgeons, Cath Lab, Design Control, Hardware Diagnostics, Urology, Spine, Surgical Instruments, Cardiac Surgery, Orthopedic, Medical Imaging, Sales Effectiveness, Neurology, Medical Diagnostics
Education
Marquette University
Bachelor of Science (B.S.), Medical Technology
Neovasc June 2014 - Present
Sunshine Heart, Inc October 2012 - May 2014
St. Jude Medical March 2008 - October 2012
St. Jude Medical January 2006 - March 2008
Medtronic July 2003 - January 2006
Medtronic February 2002 - July 2003
Minnesota Gastroenterology March 1999 - May 2002
Minnesota Gastroenterology April 1993 - March 1999
Skills
Medical Devices, Clinical Monitoring, Clinical Research, Clinical Trials, Clinical Study Design, Program Management, Personnel Supervision, Protocol, Cardiology, CTMS, Heart Failure, CRO, GCP, ISO 13485, FDA, Surgery, Regulatory Affairs, Design Control, EDC, Clinical Development, Regulatory Submissions, Clinical Data Management, ICH-GCP, Neurology, Interventional..., Electrophysiology, PMA, Vascular
Education
St. Olaf College 1977 — 1981
BSN
Sunshine Heart, Inc January 2013 - Present
Kroll Ontrack January 2010 - January 2013
Teradyne 1999 - 2009
Medtronic 1999 - 1999
Unisys 1997 - 1999
Analysts International 1996 - 1999
3M 1996 - 1997
Arcata Associates 1996 - 1996
GTE Government Systems 1994 - 1996
Texas Instruments 1993 - 1994
Skills
C++, UML, Architecture, C#, Software Development, Object Oriented Design, Software Engineering, XML, OOAD, Visual Studio, GUI, .NET, SDLC
Education
South Dakota School of Mines and Technology 1989 — 1992
Bachelor, Computer Science, Mathematics
IVCC Ilinois Valley Community College 1985 — 1988
Associate, Engineering
Ottawa Township High School 1981 — 1985
Heart Leaflet Technologies (HLT) May 2014 - Present
Sunshine Heart, Inc January 2012 - May 2014
Sunshine Heart Inc. October 2010 - December 2011
Acorn Cardiovascular, Inc. May 2007 - September 2010
Acorn Cardiovascular, Inc. January 2004 - April 2007
St. Paul Consulting May 1997 - December 2003
Grant Thornton, LLP March 1994 - April 1997
Accenture (formerly Andersen Consulting) January 1992 - February 1994
Skills
R&D, FDA, Quality Assurance, Cross-functional Team..., Quality System, ISO 13485, Medical Devices, CAPA, Quality Auditing, Biomedical Engineering, Process Improvement, Start-ups, Quality Management, Manufacturing, Validation, Manufacturing..., Design for Manufacturing, Product Development, GMP, Design Control, Root Cause Analysis, FMEA
Education
St. John's University 1987 — 1991
Bachelor of Science (BS), Accounting and English
University of Minnesota - Carlson School of Management
Master of Business Administration (MBA), Operations Management and Supervision
Lutonix (subsidiary of CR Bard) July 2015 - Present
Sunshine Heart, Inc January 2015 - June 2015
Sunshine Heart March 2013 - January 2015
St. Jude Medical February 2010 - March 2013
St. Jude Medical February 2010 - November 2010
St. Jude Medical July 2009 - January 2010
St. Jude Medical February 2003 - September 2005
St. Jude Medical February 2001 - February 2003
Skills
Cardiac, Nursing, Clinical, Hospitals, Medical Devices, Cath Lab, Pediatrics, Health, Cardiac Surgery, Clinical Trials, Cardiology, PMA, Neurology, Heart Failure, Clinical Research, Clinical Monitoring, Clinical Study Design, Medical Device Product..., ISO 14155, Electronic data capture, Protocol Development, GCP, 21 CFR, Oracle Clinical, HIPAA, FMEA, Health and Hazard..., Adverse Event Reporting, Clinical Event..., DSMB Coordination, CRF Development, Patient Informed Consent, CRF design, EDC, Vascular, Protocol, FDA
Education
University of Minnesota-Twin Cities
Psychology and Journalism
Normandale Community College
Nursing
Sunshine Heart, Inc December 2013 - Present
Service Ideas, Inc. March 2012 - December 2013
Acorn Cardiovascular September 2003 - March 2010
3M June 1984 - April 1997
Skills
Customer Service, Supply Chain, Inventory Management, Purchasing, Planning, Manufacturing, Forecasting, Logistics, Operations, Quality, Teamwork, Organizing, Problem Solving, Teaching, Coaching, Administration, Documentation, Excel, Microsoft Office, Access, Project Planning, Training
Education
APICS Certified
St. Catherine University
BA, Business Administration, Management. Economics.
Sunshine Heart Inc. August 2011 - Present
Endologix Inc November 2003 - Present
Cardiogenesis Corporation February 2007 - May 2011
Universal Building Products March 2006 - March 2011
SenoRx May 2006 - August 2010
Clarient 2006 - 2010
Sybron Dental Specialties December 1981 - May 2006
Skills
SEC filings, Financial Reporting, Accounting, Mergers, Sarbanes-Oxley Act, Financial Analysis, Auditing, Strategic Planning, Financial Modeling, Budgets, Medical Devices, Forecasting, Revenue Recognition, Mergers & Acquisitions, Private Equity, Finance, Internal Controls
Education
California State University-Fullerton, Mihaylo College of Business and Economics 1973 — 1977
MBA, Accounting