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
