Job Description
Key Responsibilities:
• Test Development & Validation
o Design, develop, Sustain and validate functional tester, test fixtures, and equipment for PCBA and system level testing.
o Create and execute validation protocols (IQ, OQ, PQ, TMV) to meet medical device regulatory requirements.
o Perform root cause analysis and troubleshooting of test failures, ensuring corrective actions are implemented.
• Compliance & Documentation
o Ensure all test processes comply with ISO 13485, FDA 21 CFR Part 820 standards.
o Maintain technical documentation, test reports, and evidence for audits and regulatory inspections.
o Support risk management activities and contribute to Design for Test (DFT) reviews.
• Production Support
o Collaborate with cross-functional teams (Program, Quality, Manufacturing) to integrate test systems into production lines.
o Monitor tester performance, yield, and cycle time, drive continuous improvement initiatives.
o Support factory acceptan...
• Test Development & Validation
o Design, develop, Sustain and validate functional tester, test fixtures, and equipment for PCBA and system level testing.
o Create and execute validation protocols (IQ, OQ, PQ, TMV) to meet medical device regulatory requirements.
o Perform root cause analysis and troubleshooting of test failures, ensuring corrective actions are implemented.
• Compliance & Documentation
o Ensure all test processes comply with ISO 13485, FDA 21 CFR Part 820 standards.
o Maintain technical documentation, test reports, and evidence for audits and regulatory inspections.
o Support risk management activities and contribute to Design for Test (DFT) reviews.
• Production Support
o Collaborate with cross-functional teams (Program, Quality, Manufacturing) to integrate test systems into production lines.
o Monitor tester performance, yield, and cycle time, drive continuous improvement initiatives.
o Support factory acceptan...
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