Process Development Engineer - Medical Device Assembly

medmix is ​​a global leader in high-precision delivery devices. We hold leading positions in the healthcare, consumer, and industrial end markets. Our customers benefit from our commitment to innovation and technological advancement, reflected in over 900 active patents. With 14 production sites worldwide and a highly motivated, experienced team of nearly 2,700 employees, we offer our customers uncompromising quality, proximity, and flexibility.

Haselmeier, part of medmix, has been established in the healthcare market for over 100 years. With a workforce of around 240 employees, Haselmeier has been a pioneer in the development of subcutaneous injection pens since the 1960s. We continue to drive innovation in self-injection pens, covering everything from design and manufacturing to packaging and delivery. We have developed solutions in scalable volumes for numerous pharmaceutical partners - always applying state-of-the-art engineering practices - and we aim to evolve further. We develop our products using a patient-centric approach. Our injection devices are used across various therapeutic areas, helping patients with diabetes, supporting fertility treatments, and even offering an option for gentle cancer therapy.

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