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