Principal R & D Engineer - Sustaining

Bachelor's Degree in Engineering - Biomedical or Mechanical engineering preferred 8+ years of work experience in engineering 5+ years of experience in medical device product development or sustaining projects Experience with design change assessment or impact analysis for regulated products Demonstrated ability to lead cross-functional teams/projects and influence outcomes without formal authority Experience or training in Problem Solving Processes Experience developing strategies or working on initiatives that result in long-term group improvements or benefits Strong understanding of design controls and risk management within the medical device industry Fundamental understanding of the Quality System per ISO 13485 or 21 CFR 820 Biomedical or anatomical understanding of urological systems Strong statistical understanding and data analysis experience Self-starter with the ability to work independently and with a team to plan, schedule and execute activities necessary to meet project timelines to schedule and within budget Experience working with cross-cultural teams Experience with Class III medical devices Technical Project Management experience Experience with product lifecycle management systems (e.g. Windchill)