Over 20 years of leadership experience In new product design through manufacturing with companies of all sizes. Expertise in FDA Regulations and expectations.
Extensive engineering and management experience in product development of Class 2 and Class 3 implantable medical devices. I've worked and managed people during initial design, detailed development, transfer to production and on-going sustaining of field issues.
Specialties: FDA expectations in Design Controls, good requirements, risk assessment, configuration control, V&V testing.
Eight years directing the manufacturing operations of Class 3 implantable medical devices. This included FDA remediation manufacturing processes.