Highly analytical, performance-driven engineering professional with 16+ years’ experience creating innovative, cost-efficient designs. Expertise in applied research, new concept development, simulation, and validation. Broad knowledge in the automotive and the medical equipment industry including repeated success developing prototypes that improve marketability for previously unfeasible technologies. Superior problem-solving and time-management abilities. Team spirited with effective communication and presentation skills.Over 10 years of combined experience in Quality,Regulatory,Clinical,and R&D in the medical device industry.Expertise is in Quality system development and compliance with ISO 13485,21 CFR part 820,Risk Management Engineering ,and compliance with ISO 14971.