Reliability Test Medical Device Professional

5 - 9 years

3 - 7 Lacs

Posted:-1 days ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

JD:

- Develop and execute reliability test plans (e.g., accelerated life testing, HALT/HASS, stress testing)

- Conduct Failure Mode and Effects Analysis (FMEA) and root cause investigations

- Collaborate with R&D to integrate reliability into product design

- Analyze test data using statistical methods (Weibull, ANOVA, DOE)

- Maintain and update Design History Files (DHF) and risk documentation per FDA and ISO standards

- Ensure compliance with ISO 13485, ISO 14971, and FDA 21 CFR 820.30

- Support design verification and validation activities

- Provide technical guidance during audits and regulatory submissions

Please prioritize and share profiles ASAP.

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