Test Engineer (PCBA HLA)

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 acceptance tests (FAT) and site acceptance tests (SAT) for new equipment before release to production.

• Supplier & Stakeholder Engagement

o Work with suppliers on tester design, fixture procurement, and instrumentation readiness.

o Provide technical support to customers and internal stakeholders regarding test requirements and implementation.

Requirements:

• Degree/Diploma in Electrical/Electronics Engineering or related field.

• Experience in medical device manufacturing or regulated industries.

• Strong knowledge of automated test equipment (ATE, ICT, FCT) and data analysis tools.

• Familiarity with regulatory compliance standards (ISO 13485, FDA, IEC).

• Skills in project management, documentation, and cross-functional collaboration

** This role requires candidate to travel.