CVRx Company
Industry: Company
DescriptionHeadquarters: Maple Grove, MN Founded: 2000
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CVRx Employees
Assured Regulatory and Clinical Consulting, Inc. 2013 - Present
CVRx 2006 - 2013
St. Jude Medical 2000 - 2006
W.L. Gore & Associates 1997 - 2000
Skills
FDA, Clinical Trials, Clinical Research, Regulatory Affairs, Clinical Development, Medical Devices, Regulatory Requirements, Regulatory Submissions, Global Strategy..., Leadership, CE marking, Quality System, Commercialization, PMA, Validation, Product Development, Design Control, ISO 14971, Biomedical Engineering, Biotechnology, GMP, Biologics, Medical Device Directive, 510(k), Neuromodulation, ISO 13485, Pharmaceuticals
Education
University of Minnesota - Carlson School of Management
MBA
University of Minnesota-Twin Cities
BS
KPMG US January 2015 - April 2015
CVRx September 2014 - December 2014
Nebraska Spine Hospital June 2014 - August 2014
Nebraska Spine Hospital June 2013 - July 2013
School of Physics and Astronomy, University of Minnesota - Twin Cities May 2012 - June 2012
Skills
Research, Microsoft Office, Strategic Planning, Team Leadership, Data Analysis, Team Building, Analysis, Microsoft Word, Time Management, Accounting, Auditing
Education
University of Minnesota-Twin Cities 2011 — 2016
Bachelor of Science in Business, Accounting major, Computer Science minor
University of Cambridge 2012 — 2012
Millard North High School 2007 — 2011
CVRx June 2008 - Present
Manhattan Toy June 2000 - June 2008
URS Corporation January 1996 - June 2000
Skills
Microsoft Certified..., VMware, Citrix Metaframe, Microsoft SQL Server, Network Security, Information Technology, Firewalls, Troubleshooting, Cross-functional Team..., IT Operations, Medical Devices, Process Improvement, FDA, Microsoft CRM, IT Management, Quality System, Storage Area Networks, Microsoft Exchange, Windows Server, SharePoint, VoIP, WAN, Microsoft Office, Virtualization, Project Management, Technical Documentation, Business Analysis, ShoreTel, Compellent, Microsoft Dynamics ERP, Netscaler, Backup Solutions, Barracuda Spam Firewall, Capital Budgeting, Purchasing, Employee Training, Warehouse Management, Return on Investment, VLAN, Switches
Education
Augsburg College
Bethel University
BS, Business
City of Mequon May 2014 - October 2014
Marquette University August 2012 - August 2013
Marquette University August 2012 - August 2013
CVRx May 2012 - August 2012
Michigan Technological University March 2011 - April 2012
Skills
Engineering, Labview, Unigraphics, Solidworks, AutoCAD, Matlab, Mechanics, Machining, Microsoft Office, Microsoft Excel
Education
Milwaukee School of Engineering 2013 — 2016
Master’s Degree, Structural Engineering
Marquette University 2012 — 2013
Bioengineering and Biomedical Engineering
Michigan Technological University 2008 — 2012
Bachelor's degree, Biomedical/Medical Engineering
Medtronic November 2014 - Present
Bet Shalom Reform Congregation September 2014 - Present
Gan Shalom Preschool January 2014 - May 2014
UnityPoint Health August 2013 - May 2014
CVRx May 2013 - August 2013
Drake University September 2012 - May 2013
BridgePoint Medical, Inc. January 2013 - January 2013
Bet Shalom Religious School September 2005 - May 2010
Skills
Clinical Research, Clinical Trials, IRB, Hard Working, CRFs, FDA regulation with IDE..., Eager/fast learner, Organization, Punctual, Research
Education
Drake University 2010 — 2014
Bachelor's of Science, Health Science - Pharmaceutical Sciences
Corindus Inc. October 2013 - Present
ZOLL Medical Corporation July 2011 - October 2013
Edwards Lifesciences May 2010 - July 2011
Pavad Medical 2008 - 2010
Spineology Inc. 2005 - 2007
CVRx 2002 - 2005
Augustine Medical (Arizant Healthcare-3M) 2000 - 2002
Novoste Corporation 1998 - 2000
Datascope 1995 - 1997
Fairview Southdale Hospital 1994 - 1997
Skills
Medical Devices, Clinical Research, Cardiology, FDA, Clinical Trials, Clinical Study Design, CCRA, Regulatory Affairs, Clinical Development, Cath Lab, Oncology, Clinical Monitoring, Spine, Hypertension, Healthcare, CTMS, Interventional..., Vascular, GCP, Orthopedic
Education
University of Missouri-Kansas City 1998 — 2000
MBA
Central Missouri State University 1986 — 1990
BSN, Nursing
Fairview Health Services August 2014 - Present
Fairview Health Services September 2011 - August 2014
Fairview Health Services February 2011 - September 2011
CVRx November 2008 - January 2011
Skills
Microsoft Office, Microsoft Word, Microsoft Excel, PowerPoint, Customer Service, Teamwork, Photoshop, Social Media, Time Management, Research, Public Speaking, Retail, Medical Records, Healthcare, HIPAA
Education
North Hennepin Community College 2008 — 2012
Associate of Arts and Sciences (AAS), Business Administration and Management, General
Rasmussen College-Minnesota
CVRx President & CEOCVRxJune 2001 - October 2006
Medtronic 1992 - 1999
Skills
Medical Devices, Lifesciences, Leadership, Entrepreneurship, Venture Capital, Start-up Ventures, Fundraising, Intellectual Property, Public Speaking, Board of Director..., Industry Advocacy, Start-ups, Strategic Planning, Commercialization, Board of Directors, Healthcare, Market Development, Patents, Biotechnology, Life Sciences, Product Launch, Cardiology, Cross-functional Team...
Education
University of Pennsylvania 1987 — 1991
Ph.D., Physiology
University of Pennsylvania 1983 — 1987
V.M.D., Veterinary Medicine
University of Pennsylvania 1978 — 1982
B.A., Natural Science
Great Neck North Sr. High School 1975 — 1978
MicroPlumbers Microsciences October 2006 - Present
Ativa Medical 2009 - 2012
Honeywell December 2004 - April 2006
General Dynamics February 2004 - December 2004
CVRx 2003 - 2003
Medtronic December 1988 - April 2002
Skills
Design of Experiments, Medical Devices, Product Design, R&D, Design Control, Six Sigma, Materials Science, Data Analysis, Statistics, Failure Analysis, Product Development, Biocompatibility, Project Planning, Program Management, Reliability, FMEA, Process Simulation, Manufacturing, Intellectual Property, Technical Presentations, ISO 13485, Risk Assessment, Cross-functional Team..., Class II Medical Devices, Biomaterials, Lean Manufacturing, Cross Functional Team..., microfluidics, Medical Diagnostics, Class III Medical..., clinical chemistry tests, process development, microfluidic circuit..., R & D, Quality, Surface Chemistry, Continuous Improvement, Technical Writing, FDA, troubleshooting, Biomedical Engineering, Metalurgy, Process Optimization, MS Project, sample preparation, Brazing, Ceramics, Polymers, Validation, Quality System
Education
University of Minnesota-Twin Cities 1986 — 1988
MS, Materials Science
University of Minnesota-Twin Cities 1982 — 1986
BS, Materials Science
University of Iowa
Bachelor's Degree, Music
Corindus Vascular Robotics April 2013 - Present
Hansen Medical May 2009 - April 2013
CVRx December 2006 - May 2009
Kensey Nash Corporation July 2002 - December 2006
Skills
Clinical Research, Clinical Trials, Sales, Management, Medicine, Training, Medical Devices, Interventional..., Capital Equipment, Cardiology, Vascular, Surgery, Medical Imaging, Cross-functional Team..., Start-ups, Cath Lab, Operating Room, Surgeons, Market Development, Disposables, Urology, Surgical Instruments, Interventional Radiology
Education
California Coast University
BS, Management
School of Cardiovascular Technology
Program Diploma, Invasive Cardiovascular Technology
NAMSA January 2011 - Present
Cleveland Clinic January 1993 - Present
CVRx 2009 - 2011
Masimo Corporation May 2005 - May 2008
ELA / Sorin March 1994 - March 2005
MetroHealth Medical Center 1993 - 1998
Skills
Engineering, Clinical Trials, Critical Care, Account Management, Sales Management, Sales Support, Education, Emergency Medicine, Cardiology, Electrophysiology, Research, Clinical Research, Nursing, Neuromodulation, GCP, Hospitals, Surgery, CTMS, ICU, Orthopedic
Education
Cuyahoga Community College
Tiffin University
Bachelor in Organizational Management, Business
HighJump Software 2013 - 2014
Boston Scientific 2013 - 2013
Medtronic 2008 - 2013
UPCARE Technology, Inc. 2007 - 2008
Datacard Group 2004 - 2007
3M 2004 - 2004
ATMI, Inc. (now part of Entegris) 2004 - 2004
Polaris Industries 2004 - 2004
CVRx 2003 - 2004
Irish Genealogical Society International (IGSI) 2003 - 2004
Skills
Medical Devices, Project Management, Content Development, Creative Problem Solving, Needs Analysis, Multiple..., Technical Writing, Quality Assurance, XML, Editing, Technical Communication, Technical Documentation, SharePoint, Manuals, Cross-functional Team..., Software Documentation, E-Learning, Online Help, Testing, SnagIt, Critical Thinking, RoboHelp, Training, Content Management, Adobe Acrobat, FrameMaker, Visio
Education
Central Michigan University
Bachelor of Science (B.S.)
Washtenaw Community College
CVRx August 2008 - Present
Boston Scientific September 2000 - August 2008
Guidant Corporation June 1999 - September 2000
Keithley Instruments January 1998 - August 1998
Skills
ISO 13485, Supply Chain Management, ISO 14971, ASIC, CAPA, Quality Systems, CE marking, FDA, QSR, Risk Management, Six Sigma, Lean Manufacturing, Medical Devices, Quality Engineering, Minitab, FMEA, Design Control, Root Cause Analysis, Cross-functional Team..., Supplier Quality, Failure Analysis, DOE, Process Development, Quality System, Validation, Testing, Electronics, Design of Experiments, Quality Assurance, V&V, DMAIC, Manufacturing
Education
Case Western Reserve University 1995 — 1999
Bachelor's of Science, Electrical Engineering
CVRx October 2007 - Present
Skills
Medical Devices, Patents, Genomics, Patent Prosecution, Trademarks, Commercialization, Intellectual Property, Intellectual Asset..., Clinical Trials, Technology Transfer, Licensing, Lifesciences, Biotechnology, Regulatory Affairs, Biomedical Engineering, R&D, Clinical Development, Design Control, Patentability, FDA, ISO 13485
Education
University of Minnesota-Twin Cities 2003 — 2005
M.S., Business, Management of Technology
Northern Illinois University 1992 — 1995
B.S., Biochemistry, Biological Sciences
BioControl Medical October 2011 - Present
The Integra Group January 2011 - July 2012
CVRx July 2009 - June 2011
Medical Simulation Corporation June 2008 - July 2009
BayCare Health System June 2003 - June 2008
Delray Medical Center May 1999 - June 2003
Zachariah P. Zachariah, MD., P.A. August 1996 - May 1999
Skills
Medical Devices, Clinical Research, Clinical Trials, Cardiology, Neuromodulation, Device Management, Clinical Trial..., Technology..., Clinical Expertise, Biotechnology, Clinical Site Management, Cath Lab, Interventional..., Neuroscience, Simulation, Nursing, Critical Care, Six Sigma, Nursing Administration, Surgery, ICH-GCP, Heart Failure, Interventional Radiology, Biomedical Engineering, Neurology, CTMS, FDA, Healthcare, Hospitals, Clinical Development
Education
Florida International University 1996 — 1998
BS, Nursing
Florida Atlantic University 1992 — 1994
Education, Microbiology
CVRx January 2008 - July 2013
Medtronic July 2003 - January 2008
Medtronic February 2000 - July 2003
Medtronic November 1997 - February 2000
Itron 1996 - 1997
Motorola Mobility 1996 - 1997
Motorola Mobility 1992 - 1995
Skills
Cadence Spectre, HSpice, MKS Integrity, MathCAD, Analog Circuit Design, Biomedical Engineering, Medical Devices, FDA, System Requirements, ISO 13485, SPICE, Design of Experiments, IC, Testing, Mixed Signal, Sensors, Engineering, Manufacturing, Simulations, Integrated Circuit..., Design for Manufacturing, R&D, Labview, Design Control, RF design, Embedded Systems, ISO 14971, Failure Analysis
Education
University of Minnesota-Twin Cities 1988 — 1992
Bachelor's of Science, Electrical Engineering
MicroOptx Inc. August 2015 - Present
NAMSA July 2012 - July 2015
NAMSA July 2012 - July 2015
The Integra Group May 2005 - July 2012
CVRx June 2002 - April 2005
Medtronic May 1999 - May 2002
Medtronic 1992 - 2002
Skills
Medical Devices, FDA, Capital Equipment, Clinical Trials, Clinical Development, Lifesciences, Quality Assurance, GLP, Healthcare, CTMS, Regulatory Affairs, Medicine, Surgery, ISO 13485, Clinical Research, Biotechnology, Cardiology, Hardware Diagnostics, R&D, Pharmaceutical Industry, Laboratory, Biostatistics, CRO, Biomedical Engineering, Orthopedic, Clinical Study Design, GCP, Immunology, Commercialization, Neurology, Infectious Diseases, Drug Development, Interventional..., Sop, Regulatory Submissions, PMA, Protocol, GMP, Oncology, Biopharmaceuticals, Heart Failure, Validation, Clinical Monitoring, Translational Research, Neuromodulation, Medical Writing, Cancer, Biomaterials, Vaccines, Electrophysiology
Education
University of Minnesota-Twin Cities 1985 — 1989
D.V.M, Veterinary Medicine
University of St. Thomas 1975 — 1979
B.A, Biochemistry
Merck June 2015 - Present
Hunterdon Medical Center 2009 - Present
Janssen Pharmaceuticals R&D of Johnson and Johnson 2014 - April 2015
Janssen Pharmaceuticals R&D of Johnson and Johnson 2012 - 2014
Merck 2007 - 2012
University of Michigan Medical School 1998 - 2008
CVRx 2005 - 2007
The Ohio State University Medical Center 1988 - 1998
Weill Cornell Medical College 1980 - 1988
Massachusetts General Hospital 1978 - 1980
Skills
Medical Education, Clinical Research, Cardiovascular Medicine, Strategic Planning, Clinical Trials, Medical Writing, Change Management, Product Development, Medicine, Cardiology, Hospitals, Heart Failure, Clinical Development, Pharmaceutical Industry, Healthcare, Drug Development, Internal Medicine, Medical Devices, Therapeutic Areas, Cardiovascular Disease, Hypertension, Oncology
Education
University of Michigan - Stephen M. Ross School of Business 2001 — 2003
MBA Master of Business Administration, Business
Penn State University 1970 — 1974
MD Medical Doctor Hershey Medical Center, Medicine
Saint Joseph's University 1966 — 1970
BS Bachelor of Science, Biology
EBR systems inc July 2015 - Present
Keystone Heart Ltd. October 2014 - March 2015
Abiomed May 2013 - September 2014
CVRx January 2009 - May 2013
Medtronic February 2007 - February 2009
Medtronic October 2003 - February 2007
The Queen's Medical Center 1999 - 2003
Skills
Medical Devices, Clinical Trials, Medical Sales, Start-ups, Class III Medical..., PMA, Cardiac..., cardiac cath, Interventional..., Interventional Radiology, Early-stage Startups, Product Development, Hospitals, Healthcare Consulting, Healthcare Analytics, Heart Failure, Cardiology, FDA, Operating Room, Cath Lab, Cardiac Cath, Product Launch, Cross-functional Team..., Management, Surgery, Clinical Research, Surgeons
Education
Northwestern University - Kellogg School of Management 2013 — 2015
Master of Business Administration (MBA)
University of California, Los Angeles
Business Administration and Management, General
Santa Monica College
CVRx February 2010 - Present
Spring Lake Park Schools January 2006 - Present
CVRx June 2006 - February 2010
Medtronic September 1987 - June 2006
Skills
Medical Devices, Embedded Systems, Engineering, Product Development, R&D, Systems Engineering, Biomedical Engineering, Process Simulation, Cross-functional Team..., FDA, Design Control, Lifesciences, ISO 13485, Patents, Testing, Design of Experiments, Quality System, Design for Manufacturing, FMEA, Validation, Commercialization, Engineering Management, Product Launch, Root Cause Analysis, Failure Analysis
Education
University of Minnesota-Twin Cities 1985 — 1990
BEE, Electrical and Electronics Engineering
CVRx Member Board of DirectorsHansen MedicalAugust 2012 - Present
Medtronic May 2002 - October 2006
GE Healthcare July 1992 - May 2002
Data Management (IDM now) 1990 - 1991
Skills
Medical Devices, Market Development, Commercialization, Biomedical Engineering, Product Launch, Capital Equipment, FDA, ISO 13485, R&D, Cross-functional Team..., Product Development, Start-ups, Biotechnology, Cardiology, Lifesciences, Quality System, Healthcare, Regulatory Affairs, Business Strategy, Clinical Trials
Education
INSEAD 1996 — 1997
MBA
Telecom ParisTech 1991 — 1993
Engineer
Ecole Superieure des Ingenieurs de Beyrouth 1985 — 1990
Engineer's degree, Electrical and Electronics Engineering
Preventice January 2015 - Present
Independent Consultant March 2014 - January 2015
Datalynx US, Inc. October 2013 - February 2014
CVRx February 2008 - July 2013
Compli, LLC December 2004 - January 2008
Skanska USA Building Inc. September 2003 - November 2004
Foster Wheeler June 2001 - September 2003
NNE Pharmaplan (Formerly Flaval Validation Group) December 2000 - June 2001
NNE Pharmaplan (Formerly Flaval Validation Group) March 1998 - December 2000
Vroman Systems Validation February 1996 - March 1998
Skills
Validation, 21 CFR Part 11, Computer System..., ISO, Quality Assurance, GMP, Requirements Analysis, FDA, Medical Devices, Risk Management, Agile, Compliance, Software Quality..., Auditing, Quality Systems, Change Management, Documentation, Software / Firmware QSR..., QSR, Quality System, IEC 62304, Medical Device Directive, Part 820, ISO 14971, Class III Medical..., Agile Methodologies, Sop, GLP, GAMP, Software Documentation, GxP, Quality Control, ISO 13485, V&V, Root Cause Analysis, Quality Management, Testing, CAPA, Design Control, R&D, Continuous Improvement, Change Control, Process Simulation, Quality Auditing, Automation, Manufacturing, Regulatory Affairs, Minitab, Product Development, Six Sigma
Education
Almeda University
Bachelor of Science (BS), Computer Science
Columbia Centro Universitario-Caguas 1993 — 1994
Administration
University of New Hampshire 1988 — 1988
Business
Universidad del Turabo 1986 — 1986
Programming
Universidad de Puerto Rico 1981 — 1982
Accounting
Boston Scientific June 2013 - Present
University of Michigan Health System, Department of Orthopaedic Surgery November 2012 - May 2013
University of Michigan Health System, Department of Neurosurgery September 2012 - December 2012
CVRx May 2012 - August 2012
Tornier May 2011 - August 2011
Imagine This Sold August 2008 - May 2009
Skills
Leadership, Lean Manufacturing, Microsoft Excel, Design of Experiments, Supply Chain Management, Product Development, Product Design, Performance Testing, Team Leadership, Minitab, Microsoft Office, PowerPoint, Project Management, Six Sigma, Access, Statistical Modeling, Analysis, Supply Chain, Research, C++, Microsoft Word, Medical Devices, Inventory Control, Marketing, Strategic Planning, Gage R&R, Daily Operations, Yield Management, Manufacturing..., Manufacturing..., SAP, SSRS, SAP BW, MES, Manufacturing
Education
University of Michigan 2009 — 2013
Bachelor of Science (B.S.), Industrial & Operations Engineering
Clarity Clinical Consulting, LLC February 2013 - Present
Apnex Medical, Inc. October 2010 - February 2013
Osprey Medical, Inc February 2008 - October 2010
MAPS Applied Research Center January 2007 - February 2008
CVRx July 2003 - December 2006
Orphan Medical September 1999 - July 2003
Skills
Clinical Development, Clinical Trials, Clinical Research, Medical Devices, Biomedical Engineering, FDA, CTMS, R&D, GCP, CRO, Biotechnology, Cardiology, Medical Writing, Regulatory Requirements, Protocol, Clinical Study Design, Therapeutic Areas, Sop, EDC, GLP, Clinical Monitoring, ISO 13485
Education
University of Minnesota-Twin Cities 1989 — 1995
PhD, Microbiology and Immunology
Macalester College 1981 — 1985
BA, Biology
CVRx November 2012 - Present
Medtronic July 1997 - November 2012
Scott Edinger - Self Employed November 2007 - June 2009
Scott Edinger - Self Employed December 2000 - August 2001
Damark International July 1996 - July 1997
Bethel University September 1991 - July 1996
Scott Edinger - Self Employed October 1993 - April 1996
Delta Research Group January 1991 - August 1991
Micronyx August 1989 - June 1991
Skills
Software Engineering, Business Analysis, C#, .NET, Microsoft SQL Server, PowerBuilder, Java, C++, Perl, Crystal Reports, Oracle SQL, Informix, Visual Basic, IBM DOORS, Regulated Industry, Requirements Analysis, Software Design, SQL, Agile Methodologies, Embedded Software, SDLC, Software Project..., Architecture, Embedded Systems, Software Development, WPF Development, Medical Devices, Architectures
Education
LeTourneau University 1985 — 1989
Bachelor of Science (BS), Electrical Engineering
University of Manitoba 1983 — 1985
Electrical Engineering
NeuWave Medical September 2014 - Present
Covidien December 2013 - September 2014
CVRx July 2012 - December 2013
Coloplast October 2010 - July 2012
Coloplast April 2008 - October 2010
Coloplast Corporation April 2007 - October 2010
Piper Jaffray April 2005 - April 2007
SportsMark Management Group July 2004 - September 2004
Skills
Marketing Communications, Product Launch, Product Management, New Business Development, Competitive Analysis, Marketing, Market Analysis, Marketing Strategy, Brand Management, Brochures, Strategy, Market Planning, Pricing, Medical Devices, Sales Management, Global Marketing, Project Management, Forecasting, Training, Cross-functional Team..., Product Marketing
Education
University of Michigan 2001 — 2005
BA, Marketing, Communications
CVRx August 2015 - Present
Sport Ngin December 2012 - August 2015
BioAmber Inc. February 2012 - December 2012
Compellent Technologies December 2009 - February 2012
KPMG, LLP September 2004 - December 2009
Skills
Financial Analysis, Forecasting, SEC filings, Team Building, Leadership, Corporate Development, Sales Operations, Financial Reporting, Pre-IPO, IPO, SaaS, Accounting, Revenue Recognition, Corporate Tax, Compensation & Benefits, Sarbanes-Oxley Act, Financial Modeling, CRM
Education
University of Minnesota - Carlson School of Management 2002 — 2004
Bachelor of Science in Business, Accounting
Smiths Medical November 2012 - Present
Global Device Solutions, Inc. May 2010 - Present
CVRx July 2009 - May 2010
Ethicon 2007 - 2009
Closure Medical 2003 - December 2008
Medtronic January 1997 - January 2003
Coloplast 1995 - 1997
Terumo Cardiovascular Systems 1985 - 1995
Skills
R&D, Engineering, Solidworks, Design Control, Product Development, Biomedical Engineering, ISO 13485, Product Launch, Product Design, Process Development, Strategic Planning, Problem Solving, Biomaterials, Patents, Team Building, Pro/Engineer, Analysis, FDA, Cross-functional Team..., Intellectual Property, Materials, Research, Packaging, Team Leadership, Testing, Customer Relations, Quality Systems, Start-ups, Polymers, Medical Devices, Medical Device Product..., 510 K, Design for Manufacturing, CAPA
Education
Michigan State University 1981 — 1983
MSME, Mechanical Engineering
Michigan State University 1975 — 1981
bachelor of science, mechanical engineering
AtidTek, LLC July 2013 - Present
RecTech March 2011 - June 2013
Abdeo Medical Inc. March 2009 - March 2011
UCLA January 2008 - February 2010
UCLA 2008 - February 2010
CVRx April 2006 - 2008
CVRx 2006 - 2008
Skills
Wireless Networking for..., FDA, Biomedical Engineering, Medical Devices, R&D, Biotechnology, Matlab, Neuromodulation, Electrode Design, Simulations, Neuroscience, Electrophysiology, Clinical Trials, ISO 13485, Design Control, Design of Experiments, Clinical Research, Clinical Development, Life Sciences, Product Development, Cross-functional Team..., Validation, Testing, Research
Education
University of California, Los Angeles 2000 — 2006
PhD, Neuro Engineering
University of California, Los Angeles 2000 — 2005
Master’s Degree, Biomedical Engineering
Universidad Iberoamericana, Ciudad de México 1988 — 1993
BS, Physics Engineering
Boston Scientific July 2009 - Present
Boston Scientific - CRM July 1996 - Present
CVRx May 2007 - July 2009
Boston Scientific 1991 - 2007
Guidant October 1991 - July 1996
Henry Ford Hospital 1987 - 1991
Skills
Clinical Research, Medical Devices, Protocol Development, Pacemakers, Electrophysiology, Nursing, Cardiac, Cardiology, Clinical Trials, Heart Failure, Clinical Trial..., Biomedical Engineering, Biotechnology, CTMS, Cardiac Rhythm..., Cath Lab, Catheters, Clinical Development, Critical Care, Design Control, FDA, Hardware Diagnostics, Healthcare, Hospitals, ISO 13485, Interventional..., Market Development, Lifesciences, Operating Room, Protocol, Validation, Surgery
Education
Eastern Michigan University 1984 — 1987
BSN, Nursing
Henry Ford Community College 1980 — 1984
ADN, Nursing
ZOLL Medical Corporation April 2015 - Present
ZOLL Medical Corporation May 2011 - April 2015
University of Minnesota August 2008 - May 2011
The Integra Group February 2011 - April 2011
CVRx August 2008 - February 2011
University of Minnesota September 2007 - May 2009
St. Paul Heart Clinic February 2007 - August 2008
St. Paul Heart Clinic January 2006 - February 2007
Skills
Clinical Research, Medical Devices, Clinical Trials, Heart Failure, Exercise Physiology, Research, Biotechnology, Medicine, Cardiovascular..., Medical Research, Echocardiography, Cardiac Arrest, Adult CPR, Healthcare, CTMS, Protocol, FDA, Clinical Development, R&D, Orthopedic
Education
University of Minnesota-Twin Cities 2003 — 2006
PhD, Applied Physiology
University of Nebraska at Omaha 2001 — 2003
MS, Exercise Physiology
Northwestern College 1997 — 2001
BA, Exercise Science
St. Jude Medical March 2009 - Present
CVRx June 2007 - March 2009
Boston Scientific April 2003 - July 2007
Skills
Medical Devices, Biomedical Engineering, Electrophysiology, Design Control, Cardiology
Education
Rose-Hulman Institute of Technology 1995 — 1999
Boston Scientific November 2010 - Present
CVRx January 2008 - October 2010
CVRx July 2006 - January 2008
Boston Scientific/Guidant October 1997 - June 2006
Skills
R&D, Medical Devices, Leadership, Product Design, Clinical Trials, V&V, Mechanical Engineering, Design Control, Biomedical Engineering, ISO 13485, Management, FDA, DMAIC, Validation, Continuous Improvement, CAPA, Design of Experiments, Quality System
Education
University of Iowa 1994 — 1995
MS, Biomedical Engineering
University of Minnesota-Twin Cities 1987 — 1991
BS, Mechanical Engineering
Evergreen Medical Technologies March 2010 - Present
CVRx April 2007 - January 2010
Boston Scientific CRM 2001 - 2007
Skills
Biomedical Engineering, Design Control, FDA, ISO 13485, Medical Devices, CAPA, ISO 14971, Design of Experiments, V&V, Quality System, Product Design, Continuous Improvement, R&D, FMEA, Minitab, Validation, Biomaterials
Education
University of Minnesota - Twin Cites
M.S. Biomedical Engineering
University of Minnesota-Twin Cities
Master of Materials Science and Engineering
University of Illinois at Urbana-Champaign
B.S. Mechanical Engineering with Bioengineering Minor
HighJump Software March 2011 - Present
CVRx July 2010 - March 2011
Ceridian June 2009 - July 2010
UnitedHealth Group, Ovations February 2007 - June 2009
Landscape Structures, Inc January 2007 - February 2007
GMAC-RFC July 2006 - January 2007
UnitedHealth Group, Ovations June 2000 - July 2006
Skills
Agile Methodologies, .NET, SDLC, WCF, TFS, SOA, SQL, C#, Microsoft SQL Server, Silverlight, WPF, Software Development
Education
Minnesota State University, Mankato 1996 — 2001
B.S., Computer Science, Technical Writing
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
CVRx January 2006 - Present
St. Jude Medical 1997 - 2006
Angeion Corporation 1995 - 1997
Guidant 1992 - 1996
Skills
Biotechnology, Combination Products, ISO 14971, Design Control, ISO 13485, Medical Devices, FDA
Education
University of Minnesota-Twin Cities 1981 — 1983
Immunology & Public Health
North Dakota State University 1975 — 1979
B.S, Medical Technology
CVRx November 2008 - Present
Medtronic 2002 - November 2008
Tellabs 2002 - 2004
Emerson Control Techniques 1999 - 2001
Compressor Controls 1990 - 1998
Compressor Controls Corporation 1990 - 1998
intellution 1989 - 1990
Skills
Medical Devices, Design Control, Firmware, Software Engineering, Embedded Systems, C++, ISO 13485, Biomedical Engineering, Software Project..., Software Development..., Software Development..., MDA, Realtime Programming, Embedded C, embedded C++, Modbus, MKS, Rhapsody, OOAD, USB, Communication Protocols, Refactoring, Software Architectural..., LDRA, rma, ThreadX, Embedded Operating..., Atmel AVR, Polyspace, Software Requirements, Class III Medical..., Teamwork, Team Leadership, Hazard Analysis, Embedded Software, Software Prototyping, C#, Debugging Code, Code Review, Abstraction, Defect Life Cycle, Root Cause Analysis, Embedded Software..., Event Driven Programming, 68HC11, 68K, Nucleus RTOS, pvcs, Static Analysis, Software Testing Life...
Education
Iowa State University 1984 — 1989
BS, Computer Engineering
CVRx August 2007 - Present
Skills
Medical Devices, Biomedical Engineering, ISO 13485
Education
Brown College 1983 — 1985
Associates Degree
University of Minnesota-Twin Cities 1981 — 1982
Atritech, a subsidiary of Boston Scientific April 2010 - Present
CVRx July 2003 - April 2010
RCRI 2001 - 2003
Skills
Medical Devices, Clinical Trials, Clinical Research, CTMS, FDA, Cardiology, GCP, Clinical Development, Clinical Monitoring, Protocol, EDC, Regulatory Affairs, Interventional..., Clinical Data Management, Electrophysiology
Education
St. Catherine University
B.A., Psychology
Celadon Systems February 2014 - April 2015
Creganna Tactx Medical December 2012 - October 2013
CVRx June 2003 - November 2012
Urologix June 2001 - May 2003
Medtronic May 2000 - May 2001
Medtronic February 1999 - April 2000
Medtronic February 1996 - February 1999
Medtronic April 1993 - February 1996
Medtronic April 1987 - April 1993
Control Data February 1985 - December 1986
Skills
Cross-functional Team..., Lean Manufacturing, Manufacturing, Medical Devices, R&D, Engineering, Start-ups, Operations Management, Project Management, Electronics, Strategy, Manufacturing..., Forecasting, ISO 13485, FDA
Education
Lean Six Sigma Academy 2010 — 2011
Black Belt Lean Six Sigma Certificate
University of Wisconsin - Stout 1982 — 1984
Bachelor of Science, Electronics / Mfg
Inver Hills Community College 1980 — 1982
General studies
CVRx March 2006 - Present
Medtronic August 1989 - March 2006
Medtronic Microelectronics Center 1989 - 2002
Skills
ISO 13485, Medical Devices, Design Control, FDA, CAPA, ISO 14971, V&V, Risk Assessment, Continuous Improvement, Design of Experiments, Biomedical Engineering, ISO, Root Cause Analysis, Quality System, Validation, Lean Manufacturing, Manufacturing, GMP, Quality Auditing, Failure Analysis, Quality Assurance, FMEA, SPC, DMAIC, R&D, Process Simulation, Supplier Quality, Design for Manufacturing, CE marking, 21 CFR Part 11, Process Capability, Six Sigma, Regulatory Affairs, Gage R&R, Quality Management, Quality Control, Change Control, FDA GMP, Medical Device R&D, 5S, Iso 9000, Cross-functional Team..., Black Belt, Manufacturing..., Value Stream Mapping, Manufacturing Operations, Contract Manufacturing, 21 CFR, GxP, ISO 9000
Education
University of Colorado Boulder - Leeds School of Business 1988 — 1989
MBA, Operations Management/Finance
Iowa State University 1978 — 1982
BS, Electrical Engineering
Greatbatch August 2015 - Present
Greatbatch Medical November 2007 - Present
Boston Scientific June 2006 - November 2007
Boston Scientific May 2005 - August 2005
CVRx June 2003 - January 2005
Skills
Medical Devices, Lean Manufacturing, Supply Chain Management, Cross-functional Team..., Manufacturing, Quality System, Process Simulation, CAPA, FDA, Design of Experiments, Minitab, V&V, Design Control, Six Sigma, Continuous Improvement, Process Improvement, Microsoft Office, Biomedical Engineering, FMEA, 5S, Validation, Excel, Word, Problem Solving, Value Stream Mapping, Statistics, Kaizen, MS Project, Operations Management, Inventory Management, Change Management, Data Analysis, Strategic Planning, Logistics, Root Cause Analysis, Process Development, Process Validation, Project Management
Education
University of Minnesota-Twin Cities 2011 — 2015
Master of Business Administration (MBA)
Marquette University 2001 — 2006
BS, Biomedical Engineering
NAMSA August 2012 - Present
The Integra Group January 2011 - August 2012
CVRx October 2006 - January 2011
Skills
21 CFR Part 11, Regulatory Affairs, Validation, Data Analysis, Microsoft Word, Social Media, Microsoft Excel, CRO, Process Improvement, Project Management, Clinical Trials, Healthcare, Clinical Data Management, Clinical Research, HIPAA, Leadership, Clinical Monitoring, Cross-functional Team..., Research, PowerPoint, EDC, Data Management, Sales, CTMS, FDA, Marketing Communications, Quality System, Program Management, Medical Devices, Training, Protocol, Team Leadership, Access, Software Documentation, Customer Service, Database Administration, GCP, Microsoft Office, Public Speaking, Troubleshooting, Clinical Development, Sop
Education
Bethel University 2010 — 2012
MA, Commmunication
Minnesota State University, Moorhead 2004 — 2006
BA, Communication
Minnesota State University, Mankato 2002 — 2004
CVRx June 2008 - Present
Medtronic Vascular 2007 - 2008
FoxHollow Technologies 2004 - 2005
Covidien (formerly Tyco Healthcare/US Surgical) 2003 - 2004
US Surgical 1998 - 2004
Skills
Interventional..., Medical Devices, Cardiology, Capital Equipment, Market Development
Education
University of Illinois at Urbana-Champaign
BS
CVRx July 2012 - Present
Medtronic October 2010 - July 2012
Medtronic January 2009 - October 2010
Boston Scientific 2006 - 2008
Guidant France 2005 - 2006
Guidant 1998 - 2006
SNITEM 2004 - 2005
InControl 1995 - 1998
Skills
Pacemakers, Interventional..., Catheters, Heart Failure, Cardiac Surgery, Electrophysiology, ICDs, Atrial Fibrillation, Medical Devices, Leadership, Icd, Cardiology, International Business, Strategic Leadership, Market Development, Vascular, Capital Equipment, Disposables, Operating Room, Cross-functional Team..., Product Launch, Global Marketing, Strategy, Commercialization, Surgeons, Interventional Radiology
Education
University of Paris I: Panthéon-Sorbonne 1983 — 1987
Ph D, Economics;International Finance
University Paris II 1982 — 1986
BA, International Finance
Presbyterian Homes, Roseville, MN August 2010 - January 2011
CVRx 2009 - 2010
Builders Association of the Twin Cities 1996 - 2008
Education
Minneapolis Community and Technical College 2009 — 2010
Veterinary Assistant; Accounting Fundamentals
Medica July 2011 - Present
ARKRAY USA September 2009 - July 2011
CVRx December 2008 - August 2009
Skills
Problem Solving, Customer Relations, Customer Service, Microsoft Office, Salesforce.com, Microsoft CRM, Excel, Outlook, Sales Support, Health Insurance, Sales Operations, Microsoft Excel, Process Improvement, Sales
Education
Gustavus Adolphus College 2004 — 2008
Bachelors, Biology and English
Minneapolis VA Medical Center 2001 - Present
CVRx 2007 - Present
Mpls VA Medical Center 2001 - Present
Associated Nephrology Consultants, PA 1985 - 1998
Skills
Healthcare, Hospitals, Medicine, Internal Medicine, Healthcare Management, Medical Education, Clinical Research, Healthcare Information..., Public Health, Clinical Trials, Cardiology, Health Policy
Education
Harvard Medical School 1976 — 1980
M.D., medicine
University of Minnesota-Twin Cities
Bachelor of Science (BS)
HLT Medical January 2014 - Present
CVRx January 2013 - January 2014
CVRx August 2009 - January 2013
Medtronic March 2007 - August 2009
Medtronic June 2004 - March 2007
Skills
Design Control, ISO 13485, Medical Devices, Design of Experiments, Product Development, Design for Manufacturing, Manufacturing, Minitab, FDA, ISO 14971, CAPA, FMEA, Biomedical Engineering, Quality System, R, V
Education
University of Minnesota-Twin Cities 1999 — 2003
Bachelor of Mechanical Engineering, Mechanical Engineering
CVRx July 2011 - Present
CVRx March 2007 - June 2011
Skills
Regulatory Affairs, Medical Devices, FDA, Clinical Research
Education
Colorado State University 1981 — 1984
BA in Business Administration, Finance
NAMSA-Integra Group September 2012 - Present
The Integra Group February 2011 - August 2012
CVRx 2004 - 2011
Orphan Medical 1997 - 2004
Medtronic 1977 - 1985
Skills
Medical Devices, Clinical Trials, FDA, CTMS, Laboratory, Clinical Development, Heart Failure, Surgery, Medicine, Interventional..., Protocol, Clinical Research, Cardiology
Education
HCMC 1972 — 1973
MT, Medical Technology
St. Cloud State University 1970 — 1972
BS, Biology
St. Cloud State University
BSS, Biology
Boeing Commercial Airplanes March 2011 - Present
Boeing April 2010 - August 2010
CVRx May 2009 - August 2009
Skills
Engineering, Creative Problem Solving, Concept Development, Concept Design, Cost Reduction..., Solidworks, Pro Engineer, GD&T, Finite Element Analysis, Catia, Matlab, Design for Manufacturing, Engineering Management, prorduct design, Project Management, Mechanical Engineering, Youth Mentoring, Technology Integration, Non-profit Volunteer, Inventor, Enthusiasm to learn
Education
Rochester Institute of Technology 2006 — 2011
Bachelor of Science (B.S.), Mechanical Engineering/Mechanical Technology/Technician
North Hennepin Community College 2005 — 2006
PSEO Courses
CVRx August 2006 - Present
Medtronic October 1987 - August 2006
Duracell Batteries June 1982 - October 1987
Skills
Design of Experiments, Quality Assurance, Quality System, ISO 13485, Manufacturing, CAPA, Validation, FDA, Risk Management, CE marking, Supplier Quality, Design Control, 21 CFR Part 11, V&V, Medical Devices, Biomedical Engineering, Cross-functional Team..., Minitab, R&D, FMEA, Product Development, Six Sigma, SPC, Design for Manufacturing
Education
Penn State University 1978 — 1982
Bachelor of Science (BS), Chemical Engineering
CVRx April 2009 - Present
Intuitive Surgical August 2008 - March 2009
Power Medical Interventions August 2007 - August 2008
Innovative Spinal Technologies August 2006 - August 2007
Kyphon February 2004 - August 2006
US Surgical/Tyco August 1998 - February 2004
Integra LifeSciences March 1996 - August 1998
US Surgical March 1984 - March 1996
Skills
Medical Devices, Clinical Trials, Heart Failure, Hypertension, Cardiology, Account Recruitment, Account Management, Sales, Surgical Device Sales, Sales Management, Product Launch, Market Development, Operating Room, Spine, General Surgery, Cardiothoracic Surgery, Vascular Surgery, Field Operations, Corporate account..., Medical Education, Patient Education, Training Programs, Public Speaking
Education
University of Illinois at Urbana-Champaign 1974 — 1977
Retailing and Retail Operations
Purdue University August 2013 - Present
CVRx May 2015 - August 2015
Many Point Scout Camp June 2014 - August 2014
Micro Control Company May 2013 - June 2014
Skills
Matlab, C, Machine Tools, Microsoft Office, Tensile Testing, Powder X-ray Diffraction, FTIR
Education
Purdue University 2013 — 2017
Bachelor's degree, Interdisciplinary Engineering studies, Pre-Medicine