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.
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.
