About the role
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
Additional Information
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