Cross functional engineering leader with 15+ years implantable medical device experience.Participative style, coaching and mentoring team members to grow beyond current capabilities.Expertise cultivating regulatory, design, development, manufacturing and commercialization strategies.Helping new product core teams leverage 6 Sigma and Lean tools to avoid defects.Generating production floor improvements with significant recurring annual savings.Planning, coordinating, and implementing complex multi-million dollar production lines.Creating/improving Quality Systems that achieve US and international device standards.Results oriented QMS representative, with direct FDA and MDSAP regulatory exposure.
Listed skills include Iso 13485, Quality System, Capa, Medical Devices, and 32 others.