-NEW- Design Validation Senior Engineer (Medical Devices)

Job Responsibilities:

· Develop and execute comprehensive Design Validation (DV) plans, protocols, and reports, defining scope, methods, sample sizes, acceptance criteria, and traceability to user needs and design requirements.

· Design and conduct validation studies using production-equivalent devices under representative conditions to demonstrate product safety, effectiveness, and intended use.

· Plan and execute simulated-use testing with representative users and clinical workflows to validate user needs and device performance.

· Lead human factors and usability engineering activities, including use scenarios, task analyses, formative and summative studies, and use-related risk assessments.

· Apply risk-based validation strategies aligned with ISO 14971, integrating validation findings into design FMEAs, risk controls, and product design improvements.

· Plan and support clinical evaluation activities, including cadaver studies, animal studies, and clinical trials, as required to generate validation evidence.

· Prepare and maintain compliant, audit-ready validation documentation supporting ISO13485, IEC 62366, applicable FDA requirements, EU MDR, and regulatory submissions.

· Collaborate with Quality, Regulatory, R&D, Manufacturing, and Clinical teams on design reviews, validation strategy, regulatory readiness, and design transfer to manufacturing.

· Adhoc tasks and projects as assigned

Job Requirements

· Minimum Degree in a related discipline

· Minimum 6 year of relevant experience

· Able to start immediately or within short notice

Interested candidates, kindly email your detailed resumes in MS word format to joseph.koh@ambition.com.sg

Attention to Joseph Koh Wei Jie(R1873431)

Shortlisted candidates will be notified

www.ambition.com.sg

EA Registration Number: R1873431

Data provided is for recruitment purposes only

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