Process Engineer Medical Devices

Process Engineer Medical Devices

medmix

Stuttgart, Germany

Job Description

• 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.

Qualifications

Must Have:

• 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.

Nice To Have:

• 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.