Senior Design Validation Engineer – Medical Devices | V&V

Beecruit Pte Ltd; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Beecruit Pte Ltd is seeking a Senior Design Validation Engineer to lead validation activities for regulated medical devices.

You will develop and execute Design Validation strategies, protocols and reports to ensure products meet user needs and regulatory standards, working with Quality, Regulatory, Manufacturing and Clinical teams.

Qualifications

• Bachelor's degree in Biomedical, Mechanical, or Electrical Engineering.
• 6–9 years of experience in Design Validation or V&V in medical devices.
• At least 2 years focused specifically on Design Validation activities.
• Strong knowledge of ISO 13485 design controls and ISO 14971 risk management.
• Experience with Minitab/JMP, statistical analysis, sample-size justification and data interpretation.
• Knowledge of FDA 510(k), EU MDR and Class II/III regulatory pathways.
• Understanding of human factors/usability engineering and IEC 62366.
• Direct experience with endoscopic, urological or minimally invasive surgical devices is highly desirable.

Responsibilities

• Develop project-specific Design Validation Plans, including scope, methods, sample sizes and acceptance criteria.
• Develop and execute Design Validation protocols and reports for medical-device development programmes.
• Maintain traceability between user needs, design requirements, validation protocols and validation evidence within the DHF.
• Plan and execute validation studies using production-equivalent devices under representative clinical-use conditions.
• Conduct simulated-use testing with representative users such as surgeons and operating-room personnel.
• Lead human factors/usability engineering, including formative and summative usability studies.
• Develop use scenarios, task analyses and use-related risk assessments.
• Ensure alignment with IEC 62366 and FDA human-factors guidance.
• Support clinical evaluation activities such as cadaver, animal or clinical studies, where required.
• Apply ISO 14971 risk-based validation strategies and integrate findings into DFMEA and risk-management files.
• Prepare validation documentation supporting FDA 510(k), CE Mark/EU MDR and audit readiness.
• Partner with Quality, Regulatory, Manufacturing and Clinical teams throughout product development and design transfer.

Skills

Design Validation

V&V

Regulatory awareness

Statistical analysis

Risk management

Cross-functional collaboration

Endoscopic devices

Education

Bachelor's Degree in Biomedical, Mechanical, or Electrical Engineering

Tools

Minitab/JMP

ISO 13485

ISO 14971

FDA 510(k) knowledge

IEC 62366

Job description

Job Title: Senior Design Validation Engineer – Medical Devices | V&V

Employment Type: Permanent

Function: R&D / Design Quality / V&V

About the Role

We are looking for a Senior Design Validation Engineer to lead validation activities for the development of regulated medical devices.

This position will be responsible for developing and executing Design Validation strategies, protocols and reports, ensuring products meet intended user needs, clinical use requirements and applicable regulatory standards.

Key Responsibilities

• Develop project-specific Design Validation Plans, including scope, methods, sample sizes and acceptance criteria.
• Develop and execute Design Validation protocols and reports for medical-device development programmes.
• Maintain traceability between user needs, design requirements, validation protocols and validation evidence within the DHF.
• Plan and execute validation studies using production-equivalent devices under representative clinical-use conditions.
• Conduct simulated-use testing with representative users such as surgeons and operating-room personnel.
• Lead human factors/usability engineering, including formative and summative usability studies.
• Develop use scenarios, task analyses and use-related risk assessments.
• Ensure alignment with IEC 62366 and FDA human-factors guidance.
• Support clinical evaluation activities such as cadaver, animal or clinical studies, where required.
• Apply ISO 14971 risk-based validation strategies and integrate findings into DFMEA and risk-management files.
• Prepare validation documentation supporting FDA 510(k), CE Mark/EU MDR and audit readiness.
• Partner with Quality, Regulatory, Manufacturing and Clinical teams throughout product development and design transfer.

Requirements

• Bachelor's Degree in Biomedical, Mechanical, Electrical Engineering or related discipline.
• Approximately 6–9 years of experience in Design Validation, Design Quality or V&V within medical devices.
• At least 2 years specifically focused on Design Validation activities.
• Strong knowledge of ISO 13485 design controls and ISO 14971 risk management.
• Experience with Minitab/JMP, statistical analysis, sample-size justification and data interpretation.
• Knowledge of FDA 510(k), EU MDR and Class II/III medical-device regulatory pathways.
• Understanding of human factors/usability engineering and IEC 62366.
• Direct experience with endoscopic, urological or minimally invasive surgical devices is highly desirable.