Medical Devices
• Master of Science in Mechanical Engineering
• Medical device & automation experience since 1986
• Recognized as one of 100 notable people in the medical device industry by the Medical Device & Diagnostic Industry (MD&DI) publication in June 2008
Specialized in Endoscopic Surgical Devices, Respiratory Devices, Drug Delivery Devices,
Manufacturing Process Design, Design Verification and Validation, FDA and CE quality systems
regulations and Regulatory Approval Process, Product Liability, Failure and Root Cause Analysis,
Forensic Investigation, Patent Validation and Valuation, and Patent Infringement Analysis.
Experienced patent analyst: mining, infringement analysis
Experienced expert witness (incl. depositions & reports): infringement, invalidity, IPR, ITC
• 4 patents
• 68 publications (1876 citations)
• Award from Center for Regenerative Medicine
• Presented in over 70 international and national conferences and as invited speaker in 8 international
• Associate Editor, Progress in Biomaterials, Springer
• Professional membership 1) Tissue Engineering Society International 2) American Association for the Advancement of Science 3) American Chemical Society 4) Controlled Release Society
Over 17 yrs of experience
Expert in biomaterial, medical devices and tissue engineering
Highly knowledgeable on FDA regulatory and standards
• 25+ years of experience in the medical device, optics, packaging, military & consumer products industries
• Has held technical leadership positions in management, engineering, manufacturing & product development
• Decades of experience managing production transfers & cross functional teams