Design Control Specialist / Technical Project Engineer (Medical Devices / GMP) | Design Control Specialist / Technical Project Engineer (m/w/d) – Medical Devices / GMP

Job Summary

This critical role operates at the intersection of Design Control specialization and Technical Project Engineering within a major pharmaceutical company focused on Medical Devices and GMP compliance. The core responsibility involves taking technical ownership for creating and maintaining essential project documentation, strictly adhering to regulatory requirements (21 CFR 820.30) and internal Design Control processes, often executed in English. Day-to-day activities include managing specific work packages, providing expert technical consultation on processes and tools, and actively contributing to the implementation and continuous improvement of new development processes under Device Project Management Excellence. Success in this position requires a Master’s degree in Engineering or Natural Sciences, or a Bachelor’s degree complemented by extensive experience in developing medical or combination products. Candidates must possess fundamental knowledge of GMP, Change Control, and Project Management, and thrive in an international environment collaborating with R&D, Quality, Regulatory, and Production teams to ensure product quality and efficiency.