Software and Electrical Engineer with 25+ years of real-time embedded systems experience in the medical device industry. Seeking clients needing software and electronic design of embedded systems, or assistance with Product or Software Development Life Cycle processes.

Career Highlights Project Leader, Manager of Software Engineering. Pilot new Product Development Process. Major contributor in the conversion from C to OOD, C++, Rhapsody, Doors/Synergy CM, PolySpace, and CodeTEST.

Designed, implemented, tested, and maintained a number of Class II medical devices that inject contrast into patients for Angiographic, CT, and MRI procedures. Full Requirements Management and SDLC experience.

Designed, implemented, and tested a number of Class I patient examination systems used in the fields of optometry, ophthalmology, and plastic surgery. Requirements Management and Project Management.

Significant experience with FDA 21CFR820.30, "Design Control Guidance For Medical Device Manufacturers", Risk Analysis, FMEA, ISO 14971:2000, ISO 13485:2003, IEC 62304:2006-05, and IEC 60601-1.

Conducted research at the University of Cincinnati Medical Center on a portable transcutaneous power system for implantable total artificial heart and LVAD devices.