Principal R&D Engineer, Exploratory

BS degree in Engineering, Biomedical or Physics. Minimum of 8 years of experience in medical device engineering. Proven track record of developing medical devices from concept to design transfer that have made it to market. Generated core IP and patents related to commercial medical devices. Proficient in CAD software, preferably SolidWorks. Experience with mechanical and/or electrical design, mechanical/electrical drawings, tolerance analysis, and computer-aided design (CAD). 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. MS/PHD in Engineering, Biomedical or Physics. Polymer knowledge along with extrusion, injection molding experience and metallurgy. 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. Experience developing FDA class 3 medical devices. Medical Device experience in new product development with successful design from concept to commercialization is strongly preferred. Familiarity with statistical analysis of raw data is required, proficiency in Minitab is preferred. Knowledge of ASME Y14.5 GD&T. A flexible team player, focusing on shared goals with a positive results‐oriented attitude. Strong leadership skills and mentoring capabilities Strong interpersonal and communication skills (oral/presentation and written. Strong quantitative analysis and problem-solving skills and methodologies.