Profile

Professional summary

Over thirty years experience in product development, predominately in the medical device industry. Have been a director of both R&D and Program Management. Strong expertise in FDA Design Controls, including creating them as well as developing and conducting associated training for them. Supported FDA Warning Letter at two major medical device companies. Have experience in multiple other industries, including aerospace, defense and retail, and at companies of multiple sizes, including General Dynamics, Honeywell, Select Comfort, Boston Scientific, and St. Jude Medical.

Specialties: FDA Design Controls, Product Development Life Cycle, VOC, and DFSS. Strong leadership and management skills.

Engagement overview

No cost for initial engagement.  Typically it is a brief phone discussion followed by an in depth personal meeting for both parties to learn more about each other.

Clients

• Boston Scientific
• St. Jude Medical
• Nuviant Medical
• Phillips Medisize
• Covidien
• ImThera
• Minnetronix
• Victhom
• Vision Ease
• Malco
• Direct Focus, Inc.

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Areas of expertise