Design Assurance Engineer – Medical Devices

About the role

The Design Assurance Engineer will work closely with R&D, Manufacturing, Quality and Regulatory Affairs to ensure that medical devices are designed, developed, verified, validated and transferred to production in full compliance with applicable regulations and quality standards.

Key responsibilities

• Support product development from concept through commercialization while maintaining design control compliance.
• Review and approve design documentation, including inputs, outputs, verification, validation and design reviews.
• Maintain design traceability and participate in design transfer activities.
• Facilitate risk management activities (ISO 14971), hazard analyses, FMEA and ensure risk mitigation is documented.
• Develop and review validation strategies, and support execution of design verification, design validation, process validation, test method validation and equipment qualification (IQ/OQ/PQ).
• Ensure compliance with FDA QSR, ISO 13485, EU MDR and internal quality procedures; support audits and regulatory inspections.
• Analyze quality and process data, drive CAPA activities and implement continuous‑improvement initiatives using Lean Six Sigma and risk‑based methods.
• Collaborate with cross‑functional teams to provide quality and compliance guidance throughout development projects.

Required profile

• Bachelor’s degree in Biomedical, Mechanical, Electrical, Manufacturing or Quality Engineering or a related discipline.
• 3–8+ years of experience in medical devices, pharmaceuticals, biotechnology or another regulated industry.
• Experience with product development and design controls is preferred.

Required skills

• ISO 14971 (risk management)
• ISO 13485 (quality management)
• FDA Quality System Regulations (QSR)
• EU Medical Device Regulation (MDR)
• Design verification and validation
• Process validation and equipment qualification (IQ/OQ/PQ)
• Failure Modes and Effects Analysis (FMEA)
• Lean Six Sigma methodology