Design Engineer

Role OverviewAs 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 ResponsibilitiesServe 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 QualificationsBachelor’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.Fluent in both German & English. Please attach a copy of your CV.