Design Transfer Engineer

Position Schedule 1.0 FTE Type of Offer Full-time Location Responsibilities Coordinate and execute design transfer activities for medical devices from the development phase to production, in compliance with ISO 13485 and Regulation (EU) 2017/745 (MDR) Ensure the translation of design outputs into production specifications, device records (Device Master Record), and manufacturing procedures Collaborate with R&D, Quality/Regulatory Affairs (QARA), and Production teams to ensure product industrialization Support process verification and validation activities (IQ/OQ/PQ) and packaging validation (ISO 11607) Prepare and review technical documentation: transfer plans, process flowcharts, work instructions, and change control documentation Participate in risk management (ISO 14971) and in the resolution of non-conformities during production scale-up Monitor the qualification of equipment, materials, and suppliers Contribute to the continuous improvement of production processes Qualifications and Skills Degree in Engineering, such as Biomedical, Materials, Mechanical, Chemical Engineering, or a similar field Previous experience in the medical device industry will be valued Knowledge of ISO 13485, ISO 14971, and Regulation (EU) 2017/745 (MDR) will be valued Knowledge of process validation and statistical methods will be valued Strong organization, planning, and attention to detail Good communication and teamwork skills Technical English proficiency, written and spoken Sense of responsibility and proactivity #J-18808-Ljbffr