Senior Test Engineer – Design Verification & Validation (Medical Devices)

RECRUITPEDIA PTE. LTD.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

RECRUITPEDIA PTE. LTD. is seeking a qualified Test Engineer to drive design verification for medical device development projects. You will develop verification strategies, plans, and documentation, ensuring traceability from design inputs to final reports.

The role requires 5–8 years in test engineering or V&V within the medical device sector, with familiarity of FDA/EU regulations and quality systems. Collaboration with cross-functional teams is essential in an East Singapore setting.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical, Electrical, Mechatronics or related discipline.
• 5–8 years of relevant experience in test engineering, design verification or V&V, preferably in medical devices.
• Familiarity with FDA 21 CFR 820.30(f), FDA 510(k), EU MDR, ISO 14971 and ISO 13485.

Responsibilities

• Develop and implement design verification strategies for medical device development projects.
• Prepare verification plans, protocols, acceptance criteria and traceability documentation.
• Lead test readiness reviews and ensure test protocols, equipment, fixtures and samples are properly prepared.

Skills

Test engineering

Design verification

Regulatory compliance

Quality systems

Education

Bachelor's Degree in Biomedical Engineering

Tools

SolidWorks

Minitab/JMP

Job description

Our client is a leading local medical device contract manufacturer specialising in the development and manufacturing of medical devices for global markets.
Working Days: Monday – Friday
Working Hours: 8:00am – 5:30pm
Location: East

Job Responsibilities

• Develop and implement design verification strategies for medical device development projects.
• Prepare verification plans, protocols, acceptance criteria and traceability documentation.
• Lead test readiness reviews and ensure test protocols, equipment, fixtures and samples are properly prepared.
• Develop, validate and execute test methods for design verification activities.
• Design and develop clinically relevant test methods to verify product requirements.
• Design, build, qualify and maintain electro-mechanical test fixtures, jigs, test benches and related equipment.
• Conduct Installation Qualification (IQ) and Operational Qualification (OQ) for test fixtures and equipment.
• Execute verification, feasibility, reliability, accelerated life and test-to-failure studies across mechanical, electrical and system-level requirements.
• Analyse test data using appropriate statistical methods and prepare technical verification reports.
• Ensure traceability from design inputs through verification protocols, test results and final reports.
• Support regulatory submissions and maintain audit-ready technical documentation.
• Collaborate with Mechanical, Electrical, Systems, Firmware, Quality, Regulatory and Manufacturing teams throughout product development.
• Support risk assessments, design improvements and root cause investigations.
• Ensure verification activities comply with applicable medical device quality and regulatory requirements.
• Perform other duties as assigned.

Requirements

• Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Mechatronics or a related discipline.
• 5–8 years of relevant experience in test engineering, design verification or Validation & Verification (V&V), preferably within the medical device industry.
• Familiarity with FDA 21 CFR 820.30(f), FDA 510(k), EU MDR, ISO 14971 and ISO 13485.
• Experience with design controls, risk management, traceability and audit-ready documentation.
• Hands-on experience with test fixtures, electro-mechanical test equipment and test method validation.
• Knowledge of CAD tools such as SolidWorks and statistical tools such as Minitab or JMP will be an advantage.
• Experience with surgical, endoscopic, urological or minimally invasive medical devices will be an advantage.