Senior Medical Device Design Validation Engineer

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

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.