Product Developer: startup medical/scientific device industry, startup-sized business and product development processes, design for manufacturing, manufacturing outsourcing, and partner identification.
Designed and launched 3 FDA approved medical devices / assays with emphasis on lean manufacturing, tail end development, and design transfer processes.
Built business systems: ISO 13485 and FDA CFR Part 21 compliant quality systems, compliant NCR and CAPA, and product development processes
