Job Description
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
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