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Open nowPosted today

-NEW- Design Validation Senior Engineer (Medical Devices)

MyCareersFuture94,028 open roles

Pay
SGD 5,500 – SGD 7,000 a month
Where
Singapore
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Your applicationOpen now-NEW- Design Validation Senior Engineer (Medical Devices)MyCareersFuture · Singapore

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The clock on this job

Early applications get read.

7.9% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 1.6%1 day
  2. 3.4%3 days
  3. 7.9%7 days
  4. 14.2%14 days
  5. 34.1%30 days
This job: posted today

The posting

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 [email protected]

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

Business Registration Number:200611680D. License Number: 10C5117

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