-NEW- Design Validation Senior Engineer (Medical Devices)

AMBITION GROUP SINGAPORE PTE. LTD.; Singapore; On-site; SGD 120,000 - 170,000; Full time

Job summary

AMBITION GROUP SINGAPORE PTE. LTD. seeks an experienced validation professional to develop and execute comprehensive design validation plans for medical devices, linking methods to user needs and design requirements.

The role leads human factors studies, risk-based validation per ISO 14971, and supports regulatory submissions while coordinating with Quality, Regulatory, R&D, Manufacturing and Clinical teams.

Qualifications

• Minimum degree in a related discipline.
• At least 6 years of relevant validation experience.
• Immediate start preferred or available on short notice.

Responsibilities

• Develop and execute comprehensive Design Validation plans, protocols, and reports.
• Design and conduct validation studies using production-equivalent devices under representative conditions.
• Plan and execute simulated-use testing with representative users and clinical workflows.
• Lead human factors and usability engineering activities, including use scenarios and risk assessments.
• Apply ISO 14971-based validation strategies and integrate findings into design FMEAs and risk controls.
• Plan and support clinical evaluation activities to generate validation evidence.
• Prepare compliant validation documentation for ISO13485, IEC 62366, FDA, EU MDR and regulatory submissions.
• Collaborate with Quality, Regulatory, R&D, Manufacturing, and Clinical teams on design reviews and regulatory readiness.
• Adhoc tasks and projects as assigned

Skills

6+ years experience

Education

Bachelor's degree in related discipline

Job description

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

EA Registration Number: R1873431

Data provided is for recruitment purposes only

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