Senior Design Validation 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

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.