Test Engineer (PCBA HLA)

Responsibilities

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