Freelance Design Transfer (m/f/d)

Responsibilities:

• Planning, coordinating, and executing design transfer activities in accordance with regulatory requirements (ISO 13485, FDA 21 CFR Part 820)
• Interface management between R&D, Manufacturing Engineering, Quality, Regulatory Affairs, Supply Chain, and Production
• Ensuring the complete and traceable transfer of design documentation to manufacturing
• Creation, maintenance, and review of design transfer documents and technical specifications
• Conducting risk analyses (e.g., FMEA) related to production processes
• Supporting internal and external audits related to design transfer

Education/Professional Experience:

• A successfully completed degree in medical technology, mechanical engineering, biomedical engineering, or a comparable technical field
• Several years of experience in design transfer or product development within the medical technology sector
• In-depth knowledge of regulatory requirements, particularly ISO 13485, MDR (EU 2017/745), FDA 21 CFR Part 820, and design control processes
• Experience with Design History Files (DHF) and technical documentation
• Experience with risk management in accordance with ISO 14971
• Excellent written and spoken German and English skills