Test Engineer (Design Verification) | Changi | Job ID:FS26006

Job Responsibilities

• Develop and implement comprehensive design verification strategies for medical device development projects, ensuring all design inputs are verified through appropriate methods.
• Create high-level verification plans that define scope, methods, acceptance criteria, and traceability from design inputs to verification protocols and reports.
• Lead test readiness reviews (TRRs) to ensure protocols, fixtures, equipment, and samples are ready before verification execution.
• Design, develop, and validate test methods for design verification, including test instructions, validation protocols, execution, and validation reports.
• Develop clinically relevant test methods that ensure design requirements are sufficiently verified, collaborating with cross-functional partners.
• Validate test equipment and test methods to ensure measurement accuracy, repeatability, and reproducibility.
• Design, build, qualify, and maintain electro-mechanical test tools, fixtures, jigs, and test benches based on design input requirements to support automated and manual testing.
• Execute Installation Qualification (IQ) and Operational Qualification (OQ) for custom test fixtures and equipment.
• Generate and execute test protocols for design verification, feasibility assessments, and reliability/life testing across mechanical, electrical, and system-level domains.
• Conduct extended reliability tests, accelerated life testing (ALT), and test-to-failure studies to characterize design robustness.
• Analyze test data using appropriate statistical techniques and document results in verification reports.
• Write technical reports including test assessments, design verification protocols, deviation investigations, and verification summary reports for the Design History File (DHF).
• Ensure full traceability from design inputs, verification protocols, test results and verification reports.
• Contribute to documentation for regulatory submissions (510(k), CE Mark Technical File) and maintain audit-ready records.
• Support regulatory and agency submissions by providing verification data and reports.
• Collaborate with product development teams (mechanical, electrical, systems, firmware software) to characterize new hardware designs and emerging technologies.
• Work with Quality, Regulatory, and Manufacturing teams to ensure compliance with medical device standards (ISO 13485, IEC 60601, FDA 21 CFR 820).
• Ensure all verification activities comply with FDA 21 CFR 820.30(f) design verification requirements, ISO 13485 design controls, and global regulatory standards.
• Other ad-hoc tasks assigned by immediate supervisor.

Job Requirements

• Bachelor's degree in Mechanical, Electrical, Biomedical, Mechatronics or a related Engineering discipline.
• Relevant experience in design verification, test engineering or reliability testing, preferably in the medical device industry.
• Hands-on experience writing and executing test protocols and reports under design controls.
• Knowledge of ISO 13485, IEC 60601 and FDA 21 CFR 820 design control requirements.
• Strong understanding of test method validation, including measurement accuracy, repeatability and reproducibility (Gage R&R).
• Proficient in statistical analysis of test data.
• Ability to design and build electro-mechanical test setups, with automation experience being an advantage.
• Experience building or qualifying test fixtures and equipment (IQ/OQ) will be an advantage.
• Exposure to regulatory submissions (510(k), CE Mark Technical File) will be an advantage.

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