-NEW- Senior Test Engineer (Medical Devices)

AMBITION GROUP SINGAPORE PTE. LTD.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

AMBITION GROUP SINGAPORE PTE. LTD. seeks a Design Verification Engineer to lead verification strategy for medical devices, ensuring traceability from design inputs to acceptance criteria and driving cross-functional execution in a regulated environment.

You will collaborate with R&D, Quality, Regulatory and Manufacturing to validate designs, maintain DHF records, and support regulatory submissions while upholding ISO 13485 and IEC 60601 standards.

Qualifications

• Minimum Degree in a related discipline
• Minimum 6 years of relevant experience
• Able to start immediately or within short notice

Responsibilities

• Develop and execute comprehensive design verification strategies, plans, protocols, and reports, ensuring full traceability to design inputs, requirements, and acceptance criteria.
• Lead test readiness reviews and design clinically relevant verification methods to ensure appropriate test equipment, fixtures, samples, and procedures are ready for execution.
• Develop, validate, qualify, and maintain test methods, electromechanical fixtures, jigs, test benches, and equipment, Including IQ/OQ activities and measurement system assessments.
• Execute design verification, feasibility, reliability, accelerated life, and test-to-failure studies across mechanical, electrical, and system-level designs.
• Analyze test data using appropriate statistical methods, investigate deviations and failures, and prepare clear technical reports and verification summaries.
• Collaborate with R&D, Quality, Regulatory, and Manufacturing teams to characterize new designs, resolve technical issues, and ensure verification readiness throughout product development.
• Maintain audit-ready verification documentation and Design History File (DHF) records while supporting regulatory submissions with required verification evidence and reports.
• Ensure verification activities comply with applicable medical device design controls, quality systems, and standards, including ISO 13485, IEC 60601, and relevant regulatory requirements.
• Adhoc tasks and projects as assigned

Education

Degree in related discipline

Job description

Job Responsibilities:

• Develop and execute comprehensive design verification strategies, plans, protocols, and reports, ensuring full traceability to design inputs, requirements, and acceptance criteria.
• Lead test readiness reviews and design clinically relevant verification methods to ensure appropriate test equipment, fixtures, samples, and procedures are ready for execution.
• Develop, validate, qualify, and maintain test methods, electromechanical fixtures, jigs, test benches, and equipment, including IQ/OQ activities and measurement system assessments.
• Execute design verification, feasibility, reliability, accelerated life, and test-to-failure studies across mechanical, electrical, and system-level designs.
• Analyze test data using appropriate statistical methods, investigate deviations and failures, and prepare clear technical reports and verification summaries.
• Collaborate with R&D, Quality, Regulatory, and Manufacturing teams to characterize new designs, resolve technical issues, and ensure verification readiness throughout product development.
• Maintain audit-ready verification documentation and Design History File (DHF) records while supporting regulatory submissions with required verification evidence and reports.
• Ensure verification activities comply with applicable medical device design controls, quality systems, and standards, including ISO 13485, IEC 60601, and relevant regulatory requirements.
• Adhoc tasks and projects as assigned

Job Requirements

• Minimum Degree in a related discipline
• Minimum 6 year of relevant experience
• Able to start immediately or within short notice