Medical Device Tester

Title Medical Device Tester Location Mysore Bangalore Exp 5 yrs - 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