Lead systems engineering activities throughout the medical device development lifecycle, from concept development to product launch and sustaining engineering. * Define, analyze, and maintain system requirements while ensuring end-to-end traceability through design, verification, and validation. * Evaluate technical concepts, system architectures, and design solutions to ensure product performance, reliability, and patient safety. * Support regulatory submissions and compliance activities in accordance with MDR, FDA, and other applicable regulatory requirements. * Several years of experience in medical device development, systems engineering, or R&D. * Preferred Qualifications: Experience with FDA submissions, clinical evaluation, usability engineering, human factors engineering, elec
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