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Process Development Engineer - Medical Device Assembly @ medmix

Stuttgart, Baden-Wurttemberg, DEOnsiteFull-timeJob reference REF842B
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About this role

Manage and coordinate the transfer of drug delivery devices from Development to ManufacturingPrepare and maintain process documentation including process specifications, Process Map, P-FMEA, Product Concept, Manufacturing Concept etc.Conception of prototypes and define critical process parametersCommunication with production site and scheduling of project specific tasksIdentification of optimization potential in existing production processesCollaboration in the definition of processes at external suppliersProvide technical support during Root Cause Analysis, and implementation of corrective actionsCreate qualification plans and execute qualification 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 devicesCAD skills (SolidWorks) to design tooling, fixtures, and process-related componentsGood understanding of design-for-manufacturing and design-for-assembly (DFM/DFA) principlesExperience writing technical documentation and reports of medical devicesProficient in English, German skills are desirableBeing 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 documentationexperience 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 model30 days of vacation per yearCompany pension schemePublic transport ticket subsidyPluxee benefit: prepaid card with monthly creditDiscounts via the "Corporate Benefits" and "Benefits me" appsRegular company events

Skills

ResearchAssociateMedical Device

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