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.