Responsibilities:
Manufacturer of medical devices seeks an experienced Senior Engineer who is bilingual in English and Japanese. This person will assume the responsibility for the design, development, and continuous improvement of minimally invasive electromechanical cardiovascular devices. The person will perform mechanical/electrical engineering design, specification, documentation, fabrication, manufacturing scale-up, investigation, and test for new development of critical electromechanical medical devices. (1) Perform mechanical/electrical engineering design, specification, documentation, fabrication, manufacturing scale-up, investigation, and test for new development and enhancements of critical electromechanical medical devices. (2) Participate with in-house and external contract team members in the areas of specification, design, and test of subsystems and systems. (3) Lead and mentor other associates through a variety of engineering design efforts. (4) Perform bench-top development, prototyping, modeling, and testing. (5) Assess new and enhanced product designs against functional and safety requirements. (6) Communicate effectively with engineers, marketing, regulatory, quality, manufacturing personnel, management, field personnel, and customers as required. (7) Participate effectively on cross-functional design, development, and scale-up teams. (8) Should possess working knowledge of GMP/FDA regulations and guidelines. (9) May require occasional overnight travel.