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

Job Summary

This role involves acting as a Design Control Specialist and Technical Project Engineer within the pharmaceutical industry, focusing on medical and combination devices. The specialist will be primarily responsible for creating and maintaining project-relevant documentation under the Design Control process, strictly adhering to regulatory requirements (21 CFR 820.30) and internal guidelines. A significant part of the job includes technical consultation, documentation, and managing work packages within project organizations, all conducted in English. The position requires collaboration with diverse international and interdisciplinary teams (R&D, Quality, Regulatory, Production) to ensure quality and efficiency in product development. Candidates must possess a Master's degree in Engineering or Natural Sciences, or a Bachelor's degree coupled with substantial professional experience in medical device development, alongside fluent English skills and deep knowledge of GMP and Change Control processes. This is an attractive opportunity for professionals seeking a challenging role in a highly regulated international environment.