Lead Medical Device Verification Engineer

fong's engineering and manufacturing pte ltd

Singapore

On-site

SGD 72,000 - 110,000

Full time

3 days ago

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Job summary

fong's engineering and manufacturing pte ltd is seeking a Design Verification Engineer to lead comprehensive verification activities for medical device development projects. You will ensure all design inputs are validated through appropriate verification methods and maintain strict traceability from design inputs to verification reports.

You will create high-level verification plans, lead TRRs, and develop, validate, and document test methods and equipment.

Qualifications

Experience designing verification strategies for medical devices.
Ability to create verification plans with scope, methods, acceptance criteria, and traceability.
Lead TRRs and ensure readiness of protocols, fixtures, equipment, and samples.
Develop, validate, and document test methods and reports.
Collaborate with cross-functional teams to verify design requirements.
Validate test equipment and methods for accuracy and repeatability.
Execute IQ/OQ for fixtures and equipment.
Generate verification data and reports for DHF and regulatory submissions.
Ensure compliance with ISO 13485, FDA 21 CFR 820; traceability across design inputs to verification reports.

Responsibilities

Establish verification strategies from design inputs to verification reports.
Manage planning, execution, and documentation of verification activities.
Coordinate with quality, regulatory, and manufacturing teams to ensure compliance.