Medical Device Tester
Job Description
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
Skills Required
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Job Detail
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Job IdJD4397356
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationBangalore, Karnataka Mysore, Karnataka, India
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EducationNot mentioned
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ExperienceYear