Director, Product Development
Professional Experience
15+ years of experience in product development in medical device and pharmaceutical fields, including 510(k), NDA, and PAS submissions. Experience in program and project management, user needs, requirements, design controls, detailed product design (hardware and software), design for manufacturability/serviceability, risk analysis, verification and validation, design transfer, process validation, human factors, new product introduction, post market surveillance and lifecycle management. Additional expertise in hazardous/radioactive materials and cleanroom manufacturing of sterile products.
- Director, Product Development, Innovenn
- Director, Product Development, Improvita
- Director, Instrument Engineering, NorthStar Medical Radioisotopes
- Senior Manager, Mechanical and Service Engineering, NorthStar Medical Radioisotopes
- Manager, Service Development Engineering, TomoTherapy/Accuray
- Service Development Engineer, TomoTherapy
Education
Bachelor of Science – Mechanical Engineering from the University of Wisconsin – Madison
