Medical device product development specialist with start-up and publically-trade company experience. Engineering experience includes electrical engineering (analog, digital, embedded), software (C, Visual Basic), firmware, hardware, as well as mechanical engineering and systems engineering. Have implemented full quality systems (FDA quality system, ISO 9000 quality system). Have performed project management, risk management, risk analysis, failure mode and effects analysis. Additional experience in regulatory affairs (regulatory analysis, medical device 510(k) preparation), intellectual property (prior art analysis, proof of concept prototypes, device descriptions for patents), and technical writing (policies and procedures, technical reports, user manuals). 20 years combined clinical, academic and industrial experience. BA Human Biology, BS Electronic Engineering, MS Biomedical Engineering