Senior Medical Device V&V Test Engineer

RECRUITPEDIA PTE. LTD.

Singapore

On-site

SGD 90,000 - 130,000

Full time

4 days ago
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Job summary

RECRUITPEDIA PTE. LTD. on behalf of a leading local medical device contract manufacturer in Singapore seeks a Design Verification Engineer.

You will lead development and execution of verification strategies across mechanical, electrical and software aspects, ensuring traceability from design inputs to final reports. The role collaborates with Mechanical, Electrical, Systems, Firmware, Quality and Regulatory teams, conducts IQ/OQ, analyzes test data, and supports regulatory submissions.

Qualifications

  • Bachelor's degree in biomedical or related engineering field.
  • 5-8 years of experience in test engineering or V&V in medical devices.
  • Familiarity with FDA 21 CFR 820.30, ISO 13485 and ISO 14971.

Responsibilities

  • Develop and implement design verification strategies for medical device projects.
  • Prepare verification plans, protocols, acceptance criteria and traceability docs.
  • Lead test readiness reviews and ensure proper test setup and samples.
  • Develop and execute test methods for verification activities.
  • Design and develop clinically relevant test methods to verify product requirements.
  • Conduct IQ/OQ for test fixtures and equipment.
  • Analyze test data and prepare verification reports.
  • Ensure traceability from design inputs to final reports and support regulatory submissions.

Skills

Test engineering
Design verification
Statistical analysis
Test fixtures handling

Education

Bachelor's Degree in Biomedical Engineering

Tools

SolidWorks
Minitab
JMP

Job description

RECRUITPEDIA PTE. LTD. on behalf of a leading local medical device contract manufacturer in Singapore seeks a Design Verification Engineer.

You will lead development and execution of verification strategies across mechanical, electrical and software aspects, ensuring traceability from design inputs to final reports. The role collaborates with Mechanical, Electrical, Systems, Firmware, Quality and Regulatory teams, conducts IQ/OQ, analyzes test data, and supports regulatory submissions.

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