F
Fong's Engineering & Manufacturing Pte Ltd
Senior Engineer, Test
Skills
Compliance
1 month ago
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Important information
Contract type:
Permanent
Salary:
SGD 54,000 – SGD 72,000 / year
Work mode:
Onsite
Published on:
10 September 2026
What they need
- 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.
- 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.
- Support regulatory and agency submissions by providing verification data and reports.
- Other ad-hoc tasks assigned by immediate supervisor.
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