Disc Dynamics
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Disc Dynamics Employees
Ceterix Orthopaedics August 2010 - Present
Disc Dynamics March 2006 - January 2010
Ventus Medical April 2009 - 2010
ZELTIQ February 2006 - October 2009
Emphasys Medical, Inc. September 2000 - March 2009
Lumend 1999 - March 2005
AST - Advanced Stent Technologies 2003 - 2005
Perclose, Inc. January 1992 - September 2000
Devices for Vascular Intervention Inc. 1992 - 1994
Devices for Vascular Intervention Inc. 1992 - 1994
Skills
Venture Capital, Sales, Marketing, Board of Director..., Medical Devices, FDA, Product Development, R&D, Start-ups, Cross-functional Team..., Strategic Planning, Product Launch, Cardiology, Commercialization, Market Development, Clinical Trials, Manufacturing
Education
University of California, Los Angeles
BA, Economics, Psychology
University of California, Los Angeles - The Anderson School of Management
MBA
Thoratec March 2012 - Present
Hemosphere, Inc. July 2010 - March 2012
Disc Dynamics 2007 - 2009
St. Jude Medical 2005 - 2007
Endocardial Solutions 2002 - 2004
St. Jude Medical 1993 - 2001
Schneider (USA) 1991 - 1993
Upsher-Smith Laboratories 1986 - 1991
Skills
Medical Devices, Capital Equipment, Cardiology, Operating Room, Market Development, Vascular, Interventional..., Cath Lab, Surgeons, Disposables, Interventional Radiology, Spine, Pacemakers, Product Launch, Orthopedic, Surgery, Cardiac Surgery, Urology, Product Development, FDA, Cross-functional Team..., Product Marketing, Sales Operations, Orthopedics
Education
University of St. Thomas 1989 — 1993
MBA, Marketing
University of Minnesota-Twin Cities 1982 — 1985
Bachelors
Cardiovascular Systems Inc October 2011 - Present
CoAxia January 2010 - November 2012
Disc Dynamics August 2006 - December 2009
Spineology Inc. August 2005 - July 2006
Aerotek Scientific May 2005 - August 2005
Skills
Clinical Research, Design Control, Clinical Trials, Data Analysis, FDA, Medicine, GCP, Cardiology, ISO 13485, Medical Devices
Education
Anoka Ramsey Community College 2003 — 2005
Certificate, Clinical Research
Orel State Agricultural University (OSAU) 1994 — 1999
B.S, Agricultural Engineering
Medtronic August 2013 - Present
Covidien July 2011 - July 2013
St. Jude Medical February 2010 - July 2011
Disc Dynamics Inc July 2009 - December 2009
Disc Dynamics January 2008 - June 2009
Disc Dynamics November 2005 - December 2007
Disc Dynamics August 2004 - October 2005
Cordis, Johnson & Johnson April 2001 - July 2004
Terumo Cardiovascular Systems July 1997 - April 2001
Skills
ISO 13485, Six Sigma, Orthopedic, Spine, GMP, Cardiology, Electrophysiology, Medical Devices, Biomedical Engineering, Product Development, Continuous Improvement, Leadership, Design Control, FDA, Design of Experiments, CAPA, V&V, Quality System, Minitab, Quality Assurance, Root Cause Analysis, R&D, Cross-functional Team..., Lean Manufacturing, Catheters, Commercialization, Validation, ISO 14971
Education
University of Minnesota - Carlson School of Management 2010 — 2012
MBA, CEMBA (Carlson Excutive MBA Program)
Northwestern University 1996 — 1997
MS, Biomedical Engineering
University of Michigan 1992 — 1996
BS, Materials Science Engineering
Grosse Pointe South High School 1988 — 1992
Berg Professional Services, LLC April 2010 - Present
Disc Dynamics 2002 - March 2010
Envoda 2000 - 2002
Berg and Associates 1998 - 1999
Medtronic InStent 1997 - 1998
InStent, Inc. 1992 - 1997
Conseco, Inc. 1989 - 1991
Education
Gallup 2012 — 2012
Certified StrengthsFinder Coach
University of Saint Thomas - School of Business 2010 — 2010
Mini MBA
Metropolitan State University
BA, Business Administration
Lakewood Community College
Associate of Arts, Marketing
Zyga October 2009 - Present
Disc Dynamics June 2004 - June 2009
Boston Scientific February 2003 - April 2004
Minco Products, Inc 1999 - 2003
Minnesota Army National Guard August 1995 - August 2001
Carr Care Center, Inc 1988 - 1998
Skills
Medical Devices, Orthopedics, Spine, Product Development, Design Control, Capital Equipment, Biomedical Engineering, Mechanical Engineering, Manufacturing, FDA, Design of Experiments, R&D, Surgeons, CAD, Orthopedic, Surgery, Biomaterials, AutoCAD, Engineering, Six Sigma, V&V, Commercialization, Product Launch, Validation, Quality System, Surgical Instruments, Solidworks, MS Office Suite, Rental Management, Pro/Engineer, FMEA, Machining, DOE, Market Development, Operating Room, ISO 13485, ISO 14971, IEC 60601, Medical Device R&D, Patents, Machine Design, Adobe Creative Suite, WordPress, Brazilian Portuguese, Accordion, Automotive Repair
Education
University of Minnesota-Twin Cities 1997 — 2001
Bachelor's Degree, Mechanical Engineering
Ethicon June 2007 - Present
Disc Dynamics July 2005 - May 2007
Disc Dynamics October 2003 - July 2005
Aesculap January 2002 - August 2003
Encelle June 2001 - January 2002
Encelle October 1999 - June 2000
University of Pittsburgh 1999 - 2000
University of Pittsburgh January 1999 - October 1999
LifeCell Corporation January 1998 - December 1998
LifeCell Corporation September 1996 - January 1998
Skills
Biomaterials, Tissue Engineering, Design Control, New Business Development, Medical Devices, Biomedical Engineering, In Vivo, In Vitro, Spine, Polymers, FDA, Biomechanics, Orthopedics, 510 K, Surgery, Clinical, Product Development, Life Sciences, R&D, Commercialization, Research, Testing, GMP, Cell Culture, Biotechnology, Start-ups, Strategic Planning, Cell, Assay Development, Stem Cells, Cell Biology, Validation, ISO 13485
Education
University of Alabama at Birmingham 1993 — 1996
MS, Biomedical Engineering (Biomaterials, Biomechanics & Biocompatibility)
Case Western Reserve University 1989 — 1993
BS, Biomedical Engineering (Biomaterials)
Tri-Valley
inVentiv Health Clinical January 2010 - Present
Disc Dynamics August 2009 - December 2009
i3 Research January 2006 - June 2008
i3 Research October 2001 - December 2005
American Red Cross Tissue Services June 1996 - July 2000
Heart Disease Prevention Clinic 1989 - 1993
Skills
Biotechnology, Therapeutic Areas, Clinical Trials, Medical Devices, CRO, Clinical Monitoring, Clinical Research, Clinical Site Monitoring
Education
University of Minnesota-Twin Cities
Bachelors, Biology
St. Jude Medical October 2011 - Present
H&R Block January 2010 - 2012
Harland Medical Systems, Inc. January 2010 - October 2011
Disc Dynamics September 2003 - January 2010
Great Lakes Analytical March 2000 - August 2003
US Fish and Wildlife Service May 1999 - September 1999
Skills
Medical Devices, Engineering, Validation, Product Development, FDA, SPC, Six Sigma, ISO 13485, Polymers, Manufacturing, Cross-functional Team..., Design of Experiments, R&D, V&V, Quality Control
Education
Bemidji State University 1996 — 2000
B.S. Environmental Science, Chemistry, Ecosystem Biology
Hennepin Technical College
Manufacturing Engineering Technology, Mechatronics, Robotics, and Automation Engineering
St. Joseph's College (IN) 1995 — 1996
Chemistry, Biology
Tornier, Inc June 2014 - Present
Arizant Healthcare - 3M Healthcare September 2005 - June 2014
Arizant Healthcare September 2005 - June 2014
Disc Dynamics February 2005 - September 2005
Zimmer Spine January 1998 - February 2005
Shakopee Minnesota October 1995 - April 1998
Hollywood Inn September 1997 - January 1998
General office communications January 1990 - October 1995
new wait staff January 1988 - January 1990
Crossroad Medical Center June 1984 - September 1987
Skills
Medical Devices, Warehousing, Lean Manufacturing, ISO9001 Auditor, JIT, Kanban, FDA, Procurement, Inventory Management, Training, Negotiation, Manufacturing, Product Development, ISO 13485, Purchasing, Project Planning, Logistics, Management, Supply Chain, Cross-functional Team...
Education
Dakota County Vocational College 1992 — 1994
Computer Technology Study
Inver Hill Community College 1982 — 1984
Nursing and Liberal Arts Study
Inver Hills Community College 1982 — 1984
Nursing
MN Institute of Medical and Dental Assisting 1979 — 1979
Medical Assisiting
Minnesota Institute of Medical and Dental Assistance
Dakota County Vocational College
Computer Technology Study
Prior Lake High School
Kips Bay Medical, Inc. February 2012 - Present
Medtronic September 2010 - January 2012
Coloplast February 2010 - September 2010
Lumen Biomedical, Inc. November 2005 - January 2010
Disc Dynamics September 2009 - December 2009
Atritech 2004 - 2005
St. Paul Heart Clinic, PA 2000 - 2004
Parker Hughes Institute 1999 - 2000
Skills
Sop, Biotechnology, Cardiology, Cross-functional Team..., Project Management, CAPA, FDA, Clinical Research, Clinical Trials, IRB, Protocol, SOP, Surgery, Clinical Study Design, Clinical Development, Medical Devices, GCP
Education
Gustavus Adolphus College 1994 — 1998
BA, Chemistry and Biochemistry
White Bear Lake Area High School
High School Diploma
Medtronic February 2015 - Present
Medtronic July 2007 - Present
ATS Medical, Inc. August 2004 - July 2007
Disc Dynamics October 2003 - August 2004
Medtronic August 2002 - October 2003
St. Jude Medical June 2000 - August 2002
Express Scripts February 1995 - June 2000
Skills
Clinical Research, Medical Devices, Cardiology, FDA, Clinical Trials, Clinical Development, GCP, Biomedical Engineering, Neurology, Design Control, Regulatory Affairs, Clinical Study Design, CTMS, ISO 13485, Market Development, CRO, Surgery, Regulatory Submissions, Protocol, EDC
Education
University of St. Thomas - Opus College of Business 1999 — 2001
Master of International Management, Marketing
Universitaet Freiburg 1992 — 1993
Michigan State University 1989 — 1993
BA, German
Okemos High School
Medtronic September 2014 - Present
WEG August 2013 - September 2014
Westinghouse Electric Company November 2008 - June 2013
Bose Corporation January 2005 - October 2008
Disc Dynamics April 2002 - November 2004
Peritus December 2000 - August 2001
MTS Systems November 1981 - December 2000
MTS Systems 1981 - 2000
Honeywell Process Solutions January 1980 - November 1981
Skills
Mechanical Engineering, Engineering, Engineering Management, Manufacturing, Automotive, Design for Manufacturing, Project Management, Testing, Aerospace, Systems Engineering, Design Engineering, Vehicles, Medical Devices, Product Management, Product Design, Pro Engineer, Materials, R&D, Finite Element Analysis, Project Engineering, Six Sigma, FMEA, Process Engineering, Solidworks, Lean Manufacturing, Manufacturing..., Design of Experiments, CAD, Machining, Root Cause Analysis, Continuous Improvement, Automation, Product Development, DMAIC, SPC, Minitab
Education
University of Minnesota-Twin Cities 1980 — 1983
MS (not completed), Mechanical Engineering
University of Minnesota-Twin Cities 1977 — 1979
BME, Mechanical Engineer
University of Saint Thomas 1973 — 1977
BA, Biology, Premed
AtriCure, Inc. November 2014 - Present
American Medical Systems August 2011 - November 2014
American Medical Systems November 2009 - September 2011
American Medical Systems January 2008 - November 2009
Boston Scientific November 2003 - January 2008
Disc Dynamics May 2001 - August 2003
Sterotaxis, Inc February 2000 - May 2001
Vascular Solutions March 1998 - February 2000
Schneider International June 1995 - September 1997
Skills
Design Control, Product Development, Engineering, Medical Devices, R&D, FDA, Process Development, Cross-functional Team..., Product Launch, Manufacturing, GMP, Start-ups, ISO 13485, Validation, Design of Experiments, Quality System, CAPA, V&V, FMEA, Process Simulation, Biomedical Engineering, Design for Manufacturing, Commercialization, Catheters, SPC, DMAIC, Manufacturing..., Six Sigma, Minitab, ISO 14971, CE marking, Lean Manufacturing, Root Cause Analysis, Injection Molding, Cardiology
Education
Iowa State University
Bachelor of Science (BS)
Iowa State University
Master of Science (M.S.)
Pepperdine University, The George L. Graziadio School of Business and Management
MBA
Sharp Enterprises, LLC. January 2010 - Present
Zyga Technology, Inc February 2010 - Present
Disc Dynamics April 2007 - December 2009
Boston Scientific September 2004 - April 2007
Lifecore Biomedical 2000 - September 2004
Beckman Coulter 1991 - 2000
Sanofi Diagnostics Pasteur 1991 - 1995
Skills
Regulatory Affairs, PMA, Regulatory Submissions, FDA, Design Control, ISO 13485, Medical Devices, CAPA, V&V, Quality System, Validation, GMP, ISO 14971, Biomedical Engineering, Lifesciences, CE marking, Biotechnology, IDE, R&D, Clinical Trials, Regulatory Requirements, Medical Device Directive, 21 CFR
Education
University of Minnesota-Twin Cities 1985 — 1987
BS
University of Wisconsin-La Crosse 1983 — 1985
NAMSA April 2014 - Present
St. Jude Medical March 2014 - 2014
Synovis / Baxter International Inc. June 2010 - June 2013
American Medical Systems October 2009 - June 2010
Disc Dynamics September 2008 - June 2009
Myocor Inc. December 2006 - August 2008
CHF Solutions February 2005 - December 2006
Skills
Clinical Research, CTMS, Regulatory Affairs, Medical Devices, Problem Solving, Organization, Interpersonal..., GMP, Validation, Cardiology, Quality System, Heart Failure, Self-driven, Research, Liaison, Data Entry, Compliance, Database Design, Electronic Databases, Records Management, Microsoft Office, Standards Of Practice, IRB, IDE, GCP, iMedNet, Simplified Clinical..., UAT
Education
Capella University 2011 — 2013
Business, Healthcare
Anoka Ramsey Community College 2005 — 2010
BioMedical Core Certificate (2009), Biomedical
North Hennepin Community College
Project Management Fundamentals Certificate
REVA Medical, Inc. 2012 - Present
Consulting 2009 - 2012
Disc Dynamics February 2004 - June 2009
Lifecore Biomedical 2001 - 2004
GeriGene Medical Corporation 1998 - 2001
Medtronic, Inc. 1982 - 1998
Skills
ISO 13485, Medical Devices, Clinical Research, FDA, Validation, R&D, Medical Imaging, Design Control, GMP, CAPA, ISO 14971, V&V, Regulatory Affairs, Quality System, Biotechnology
Education
University of Minnesota-Twin Cities
MSEE, Electrical and Electronics Engineering
St. Jude Medical November 2010 - Present
ev3 August 2010 - November 2010
Lake Region Medical May 2010 - July 2010
St Jude Medical May 2009 - April 2010
Micromedics Inc. September 2008 - March 2009
Disc Dynamics May 2008 - August 2008
Boston Scientific July 2007 - May 2008
TSI November 2004 - July 2007
Medtronic September 2002 - October 2004
Remmele Engineering May 2002 - September 2002
Skills
Process Validation, CAPA, Manufacturing..., Validation, Design for Manufacturing, Lean Manufacturing, Engineering, Medical Devices, Continuous Improvement, Solidworks, FMEA, FDA, SPC, Process Improvement, ISO 13485, DOE, Process Engineering, Quality Engineering, Minitab, Quality Systems, Root Cause Analysis, Manufacturing, Product Development, 5S, Problem Solving, Process Development, Testing, Excel, Quality Assurance, Pro/Engineer, R&D
Education
University of Minnesota-Twin Cities 1973 — 1977
BSME, Mechanical Engineering
Anide, LLC June 2013 - Present
Bonovo Orthopedics January 2011 - May 2013
Pioneer Surgical Technology April 2003 - December 2010
Disc Dynamics 2001 - 2003
Advanced Bio-Surfaces 1998 - 2001
Pfizer 1989 - 1998
Hydron International 1987 - 1989
Skills
Design Control, Biomaterials, Medical Devices, Spine, Biomedical Engineering, ISO 13485, FDA, Orthopedic, R&D, Product Development, Surgery, Cross-functional Team..., Manufacturing, Biomechanics, Patents, Product Launch, Start-ups, Biotechnology, Market Development, Lifesciences, Design of Experiments, Quality System, Strategy, Validation, CAPA, Commercialization, Capital Equipment, Pharmaceutical Industry, Regulatory Affairs, Clinical Research, Clinical Trials, Technology Transfer, V&V, Design for Manufacturing, Surgical Instruments, Mergers & Acquisitions, GMP, Hardware Diagnostics, Cardiology, Venture Capital, Medical Imaging, Oncology, Polymers, FMEA, Biologics, Clinical Development, Global Marketing, Intellectual Property, Product Management, Quality Auditing
Education
University of Delaware 1983 — 1987
Doctor of Philosophy (Ph.D.), Chemistry
Zhejiang University 1978 — 1982
Bachelor's degree, Chemistry