Process Development Engineer Medical Device Assembly

• 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

Remote Work :

No

Employment Type :

Full-time