Process Engineer Medical Devices

Requirements

• Completed studies in a technical field (e.g. mechanical engineering, biomedical engineering, Mechatronics, medical technology)
• Several years of work experience in process development or design transfer of medical devices
• CAD skills (SolidWorks) to design tooling, fixtures, and process-related components
• Good understanding of design-for-manufacturing and design-for-assembly (DFM/DFA) principles
• Experience writing technical documentation and reports of medical devices
• Proficient in English, German skills are desirable
• Being available for occasional travel to our suppliers or our production facility in Czech Republic
• Experience with qualification activities (IQ, OQ, PQ) and related documentation
• experience or knowledge in 3D printing technologies (FDM and SLA) for rapid prototyping and process development support
• At medmix, you will become part of a renowned team. Attractive compensation and a wide range of additional benefits come as standard. You can expect the following:
• Flexible working hours under our flextime model
• 30 days of vacation per year
• Company pension scheme
• Public transport ticket subsidy
• Pluxee benefit: prepaid card with monthly credit
• Discounts via the "Corporate Benefits" and "Benefits me" apps
• Regular company events

Benefits

Additional Information

Manage and coordinate the transfer of drug delivery devices from Development to Manufacturing Prepare and maintain process documentation including process specifications, Process Map, P-FMEA, Product Concept, Manufacturing Concept etc. Conception of prototypes and define critical process parameters Communication with production site and scheduling of project specific tasks Identification of optimization potential in existing production processes Collaboration in the definition of processes at external suppliers Provide technical support during Root Cause Analysis, and implementation of corrective actions Create qualification plans and execute qualification

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