Posted:5 hours ago|
Platform:
Work from Office
Full Time
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
Idexcel
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