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

NEXBRIDGE RECRUITMENT PTE. LTD.; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

NEXBRIDGE RECRUITMENT PTE. LTD. is seeking a Design Verification Engineer in Singapore to develop and implement verification strategies for medical devices. You will lead TRRs, craft verification plans, and validate test methods and equipment across mechanical, electrical, and system domains.

The role requires experience with design controls, statistical analysis, and cooperation with cross-functional teams to ensure regulatory compliance and robust product verification.

Qualifications

• Bachelor's degree inMechanical Engineering or related field is required.
• Experience in design verification for medical devices and test reporting.
• Knowledge of design controls and regulatory standards (ISO 13485, IEC 60601, FDA 21 CFR 820).

Responsibilities

• Develop and implement design verification strategies for medical device projects.
• Create high-level verification plans with scope, methods and acceptance criteria.
• Lead TRRs to ensure readiness before verification execution.
• Design, develop, and validate test methods and verification reports.
• Collaborate with cross-functional partners to validate design requirements.
• Validate test equipment and methods for accuracy and reproducibility.
• Execute IQ/OQ for custom fixtures and equipment.
• Generate protocols for verification and reliability testing across domains.
• Conduct ALT and test-to-failure studies to assess design robustness.
• Analyze data and document results in verification reports.
• Ensure full traceability and support regulatory submissions (510(k), CE).
• Collaborate with mechanical, electrical, systems and software teams.

Skills

Design verification

Test engineering

Reliability testing

Statistical analysis

Gage R&R

Automation

Education

Mechanical Engineering

Job description

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.

We regret that only shortlisted candidates will be notified.