Lead systems engineering activities throughout the medical device development lifecycle, from concept development to product launch and sustaining engineering. * Drive cross-functional collaboration between engineering, quality, regulatory, clinical, and manufacturing stakeholders. * Master's degree in Physics, Medical Engineering, Electrical Engineering, Mechanical Engineering, or a related technical or scientific discipline. * Several years of experience in medical device development, systems engineering, or R&D. * Strong expertise in requirements engineering, design control, verification & validation, and risk management. * Preferred Qualifications: Experience with FDA submissions, clinical evaluation, usability engineering, human factors engineering, electrical or electromechanical systems, and technical leadership within cross-functional development teams.
mehr