Translate user needs, clinical risks, and business goals into reliability requirements (e.g., MTTF/MTBF, mission profiles, wear‑out models).
Develop Reliability Plans aligned to Design & Development phases and risk controls (ISO 14971).
Design for Reliability (DfR)
Partner with Systems, Electrical, Mechanical, and Software teams to design‑in reliability (materials selection, derating, thermal/mechanical margining, design rules).
Lead DFMEA/PFMEA and ensure risk controls flow into design verification and process validation strategies.