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. Drive cross-functional collaboration between engineering, quality, regulatory, clinical, and manufacturing stakeholders. Evaluate technical concepts, system architectures, and design solutions to ensure product performance, reliability, and patient safety. Coordinate risk management, design reviews, verification and validation activities, and technical assessments. Support regulatory submissions and compliance activities in accordance with MDR, FDA, and other applicable regulatory requirements. Manage technical risks, drive problem-solving activities, and ensure successful project execution with respect to scope, timeline, and quality objectives. Serve as a technical expert and mentor within interdisciplinary development teams.