Design Engineer

As a Design Assurance Engineer, you will play a critical role in embedding quality and compliance into every stage of product development. You will work closely with cross-functional teams—including R&D, Regulatory, Manufacturing, and Clinical—to support design control activities, maintain robust risk management documentation, and ensure compliance with global regulatory standards.

Key Responsibilities

• Serve as the Quality representative on cross-functional project teams for new product development and design changes to Class III devices.
• Ensure design control processes are rigorously followed and all required documentation (e.g., DHF, DMR, DHR) is developed, reviewed, and maintained.
• Lead or contribute to design risk management activities (per ISO 14971), including development of risk analyses, DFMEAs, and risk-benefit assessments.
• Review and approve design input/output documents, verification and validation plans, protocols, and reports to ensure compliance and traceability.
• Support Usability Engineering and Human Factors processes in accordance with IEC 62366.

Required Qualifications

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
• Minimum of 3 years of experience in a Quality, Design Assurance, or Regulatory role within the Class III medical device industry.
• Deep understanding of design control regulations (FDA 21 CFR 820.30), EU MDR (2017/745), and ISO 13485.
• Hands‑on experience with ISO 14971 risk management, including DFMEA and risk documentation for implantable devices.

Please attach a copy of your CV.

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