Medical Devices Expert Witness
Medical Devices | E-007664
Expert Qualifications
This expert has over 15 years of experience in the medical device industry as a quality engineer, quality systems and complaint investigator with emphasis on cardiovascular devices. A Certified Quality Engineer and Biomedical Auditor, his expertise includes managing quality systems, design and development of new product lines, product risk management and complaint investigations. He currently serves as Principal quality management systems and business Consultant for an independent consulting firm in both medical device and other industries. His understanding of medical device firm operations and intimate familiarity with medical device requirements in both the US and other geographies make him an ideal expert to provide advice in determining both legal and regulatory requirements for medical device firms as well as users (clinicians).
Bio Snapshot
Location: Minnesota
B.S., Electrical Engineering, University of Minnesota
M.B.A., Management, Argosy University Twin Cities
Certified by American Society for Quality (ASQ): Biomedical Auditor, Quality Engineer, Manager of Quality/Organizational Excellence
Senior Member, American Society for Quality
Member, ISO working group for both medical device quality management systems and general quality management systems
Member, MDIC Case for Quality Engagement Forum
Former, Principal Quality Assurance Engineer, Medtronic
Former, Principal Product Assurance Engineer, Medtronic
Former, Principal Quality Engineer, St. Jude Medical
Present, General Partner/Principal Consultant/Auditor, independent consulting firm
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