Senior Med Device Verification Engineer - Test & Validation

sg endoscopy pte. ltd.

Singapore

On-site

SGD 90,000 - 130,000

Full time

3 days ago
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Job summary

sg endoscopy pte. ltd. seeks a Design Verification Engineer to lead verification strategies for medical device development.

You will create high-level verification plans, define scope, methods, acceptance criteria, and ensure traceability from design inputs to verification reports. You will lead TRRs, design and validate test methods, develop clinically relevant tests, validate equipment, execute IQ/OQ, and generate verification documentation for the DHF, while ensuring compliance with ISO

Qualifications

  • Experience designing verification strategies for medical devices.
  • Ability to create high-level verification plans with defined scope, methods and acceptance criteria.
  • Experience leading test readiness reviews (TRRs) and coordinating verification activities.

Responsibilities

  • Develop and validate design verification test methods and reports.
  • Ensure traceability from design inputs to verification protocols and DHF documentation.
  • Lead IQ/OQ for fixtures and equipment used in verification activities.
  • Collaborate with mechanical, electrical, firmware teams to verify new hardware designs.
  • Analyze test data using statistical techniques and document results.
  • Support regulatory submissions with verification data and reports.

Skills

Design verification
Test method development
Statistical analysis
Regulatory standards
Cross-functional collaboration

Tools

Test fixtures
Measurement equipment

Job description

sg endoscopy pte. ltd. seeks a Design Verification Engineer to lead verification strategies for medical device development.

You will create high-level verification plans, define scope, methods, acceptance criteria, and ensure traceability from design inputs to verification reports. You will lead TRRs, design and validate test methods, develop clinically relevant tests, validate equipment, execute IQ/OQ, and generate verification documentation for the DHF, while ensuring compliance with ISO

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