Senior Engineer, Design Validation - $6K

PERSONNEL LINK JOBHUB PTE. LTD.; Singapore; On-site; SGD 40,000 - 67,000; Full time

Job summary

PERSONNEL LINK JOBHUB PTE. LTD. seeks a Senior Engineer in Design Validation to lead DV planning, execution, and reporting for medical devices. You will ensure traceability from user needs through validation reports within the DHF and drive usability studies to verify safe use in clinical workflows.

The role requires 6–9 years in DV/V&V with a Biomedical/Mechanical/Electrical background, and duties include coordinating clinical evaluation activities as needed. East of Singapore location.

Qualifications

• Bachelor's degree in Biomedical, Mechanical, Electrical Engineering or related field with 6-9 years in DV/Quality in the medical device industry.
• At least 2 years focused specifically on design validation activities.

Responsibilities

• Develop and maintain a Design Validation Plan defining scope, methods, sample sizes and acceptance criteria.
• Develop and execute DV protocols and reports for medical devices.
• Ensure traceability from user needs to validation documents within the DHF.
• Design and execute validation studies on initial production units under real-world conditions.
• Conduct simulated-use testing with representative users to confirm usability in clinical workflows.
• Lead human factors activities including formative and summative usability studies.
• Plan and execute clinical evaluation activities (cadaver/animal/clinical studies) as needed.

Skills

Design Validation

V&V Engineering

Biomedical Eng

Medical Devices

Usability Testing

IEC 62366

Education

Bachelors in Eng

Job description

Senior Engineer, Design Validation

• Develop and maintain a project-specific Design Validation Plan that defines scope, methods, sample sizes, and acceptance criteria, ensuring alignment with user needs and intended use.
• Develop and execute design validation (DV) protocols and reports for design and development of medical devices.
• Ensure traceability from user needs design requirements, validation protocols, validation reports within the Design History File (DHF).
• Design and execute validation studies on initial production units (or equivalents) under defined operating conditions that reflect real-world clinical use.
• Conduct simulated-use testing with representative users (e.g., surgeons, OR nurses) to confirm the device meets user needs in actual clinical workflows.
• Lead human factors engineering activities, including formative and summative usability studies, to verify safe and effective use by intended users.
• Develop use scenarios, task analyses, and use-related risk assessments to inform validation protocol design.
• Ensure compliance with IEC 62366 (usability engineering) and FDA human factors guidance for medical devices.
• Plan and execute clinical evaluation activities (e.g., cadaver studies, animal studies, or clinical trials) as needed to validate device safety and effectiveness.
• Perform other ad-hoc duties as assigned by immediate supervisor.

Requirements

• Bachelor's degree in Biomedical engineering, Mechanical Engineering, Electrical Engineering, or related field with 6-9 years of experience in design validation, design quality, or V&V engineering within the medical device industry, with at least 2 years focused specifically on design validation activities.

Salary: Up to $6K

Location: East of Singapore