Medical Device Project Engineer

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• Planning and implementation of industrialization projects in medical technology—from the concept phase to series production
• Production support (2nd level support) and further development of systems, processes, and products
• Process responsibility for defined manufacturing processes (e.g., cleaning, assembly, labeling)
• Creation of technical documentation (3D designs, specifications, validation documents, etc.)
• Coordination of internal teams and external partners such as suppliers and assembly partners
• Management of industrialization projects (internal/external, without direct management responsibility)
• Monitoring of project progress, schedule, and budget
• Ensuring quality standards, including performing checks and providing support for qualification and validation activities
• Technical support for suppliers and development partners

• Advanced degree in mechanical engineering, medical technology, mechatronics, process or systems engineering
• Additional training in plastics technology, lean management, QM, or project management is an advantage
• 5 years + of professional experience in an industrial environment, ideally in medical technology, pharmaceuticals, or the automotive industry
• Knowledge of relevant standards, regulations, and methods (e.g., ISO 13485, MDR, FMEA, CAPA)
• Experience in industrialization, automation, qualification/validation, and production-related process optimization
• Strong analytical skills
• Very good knowledge of MS Office and MS Teams, experience with ERP systems
• German and English skills (C1), other languages are an asset

Mid-Senior level

Full-time

Staffing and Recruiting