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