Lead Engineer, Systems

Job Description

As a Lead Systems Engineer, you'll define system requirements, aligning them with clinical needs and safety standards. Key responsibilities include: 1. Developing detailed product and component requirements for safety-critical systems. 2. Conducting system-level risk analysis to identify hazards and ensure regulatory compliance (ISO 14971). 3. Ensuring traceability from requirements through testing, adhering to medical device standards (ISO 13485, IEC 62304). 4. Collaborating on system-level test plans to validate functional and safety requirements. 5. Leading the integration of software, hardware, and mechanical components for real-time surgical performance. 6. Ensuring compliance with medical device regulations and supporting regulatory submissions and audits. 7. Working with cross-functional teams to optimize design decisions and meet user requirements. 8. Verifying system designs through rigorous testing and maintaining safety standards. 9. Leading design validation activities and supporting usability engineering in accordance with IEC 62366. 10. Managing design changes and their impacts, ensuring risk analysis and regulatory compliance. 11. Creating comprehensive system documentation for the development lifecycle.

Qualifications

1. Bachelor’s degree in computer science or computer/mechanical/electrical/biomedical engineering. 2. 10+ years experience in medical device development. 3. Deep understanding of medical device regulatory standards (e.g., ISO 14971, ISO 13485, IEC 62304, IEC 60601, IEC 62366). 4. Good organizational skills and excellent communication and documentation skills. 5. Excellent problem solving skills. 6. Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.