About the Role
As a Reliability Engineer, you will ensure our medical devices meet or exceed product reliability, safety, and quality requirements throughout the product lifecycle —from concept and design through verification, validation, launch, and post‑market. You will define reliability targets and models , architect test strategies (ALT/HALT/HASS/ORT) , execute root‑cause analysis , and drive corrective/preventive actions with R&D, Manufacturing/Operations, Quality/Regulatory, and Suppliers/CMs. Your work directly supports regulatory compliance (FDA/EU IVDR) and patient safety .
Key Responsibilities
Reliability Planning & Targets
- 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).
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