Principal R&D Engineering Lead

MS/PhD degree in Materials Science, or Mechanical Engineering w/emphasis on materials engineering preferred. BS in one of those fields will be considered but will be weighed heavily on work experience. Minimum of 7 years of experience in medical device engineering. Polymer knowledge along with extrusion, injection molding experience and metallurgy. Knowledge of and exposure to product testing and data collection Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD Working knowledge of mechanical design principles and FDA class 3 regulated medical device design controls. Medical Device experience in new product development with successful design from concept to commercialization is strongly preferred. This includes experience with medical device materials 7+ years product development, preferably in medical device industry. Proficient in CAD software, preferably SolidWorks. Familiarity with statistical analysis of raw data is required, proficiency in Minitab is preferred. Experience with mechanical and/or electrical design, mechanical/electrical drawings, tolerance analysis, and computer-aided design (CAD) Track record of strong cross-functional collaboration, influence without authority, and project management enabling highly effective project teams. Knowledge, Skills, and Abilities: Excellent hands-on mechanical prototyping, verification, and failure analysis skills. Proven self-starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with a demonstrated ability to rally teams to achieve business results. Familiarity with design control according to 21 CFR 820 or ISO 13485, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA). Strong leadership skills and mentoring capabilities Strong quantitative analysis and problem-solving skills and methodologies Strong interpersonal and communication skills (oral/presentation and written) A flexible team player, focusing on shared goals with a positive results‐oriented attitude. Proficient in Risk Management according to ISO 14971. Knowledge of ASME Y14.5 GD&T.