Technical Transfer Manager – Medical Devices (m/f/d) 80 - 100%

Join an Innovative Team in the Medical Device Sector

We are seeking a dedicated professional to take on a pivotal role within an internationally acclaimed pharmaceutical company renowned for its cutting-edge medical devices and combination products. The organization is at the forefront of the global life sciences industry, distinguished by its strong commitment to quality, technological excellence, and patient-focused solutions.

Your Key Responsibilities

• Lead technical transfer projects for combination products, medical devices, and secondary packaging across an international manufacturing network.
• Define and implement a cohesive transfer strategy that aligns development activities with site-level operations.
• Serve as the Transfer Team Lead for device and packaging launch activities, coordinating cross-functional project teams.
• Support the lifecycle management of existing products and oversee the implementation of changes to the device platform.
• Collaborate closely with teams in Device Development, Technical Operations, Regulatory Affairs, and Supply Chain.
• Contribute to both internal and external audits regarding packaging and medical device topics.
• Prepare technical documentation for medical device and combination product registrations and address questions from health authorities.
• Provide crucial manufacturing insights during the design control stages of device development.

Your Professional Profile

• A completed degree (e.g., PhD or engineering degree) in Mechanical Engineering, Pharmaceutical Technology, or a related discipline.
• Several years of professional experience in pharmaceutical manufacturing, preferably in assembly and packaging, manufacturing science and technology, or technical development.
• In-depth knowledge of design control documentation such as DHF, DMR, pFMEA, and URS.
• Familiarity with regulatory frameworks, including 21 CFR Part 210/211, 21 CFR Part 4/820, ISO 13485, and relevant medical device directives.
• Strong project management skills complemented by excellent analytical and technical reporting capabilities.
• A confident communicator with intercultural sensitivity, adept at navigating a global matrix organization.
• Fluency in English; proficiency in additional languages is an asset.

If you are ready to shape the future of medical device manufacturing, we invite you to explore this opportunity to make a significant impact in a dynamic and innovative environment.