Process Development Engineer - Medical Device Assembly
About The Position
The Process Development Engineer will manage and coordinate the transfer of drug delivery devices from Development to Manufacturing. The role prepares and maintains process documentation, including process specifications, Process Maps, P-FMEAs, Product Concepts, and Manufacturing Concepts. It also involves conceiving prototypes, defining critical process parameters, coordinating project-specific tasks with the production site, identifying opportunities to optimize existing production processes, and collaborating on process definition with external suppliers. The engineer provides technical support during root cause analysis and implementation of corrective actions, and creates and executes qualification plans. The position is based in the Drug Delivery Business Unit in Stuttgart, Germany, and is described as hybrid. Occasional travel to suppliers or the production facility in the Czech Republic is required.
Requirements
- Completed studies in a technical field, such as mechanical engineering, biomedical engineering, mechatronics, or medical technology.
- Several years of work experience in process development or design transfer of medical devices.
- CAD skills in SolidWorks for designing tooling, fixtures, and process-related components.
- Good understanding of design-for-manufacturing (DFM) and design-for-assembly (DFA) principles.
- Experience writing technical documentation and reports for medical devices.
- Proficiency in English.
- Availability for occasional travel to suppliers or the production facility in the Czech Republic.
Nice To Haves
- German language skills.
- 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.
Responsibilities
- Manage and coordinate the transfer of drug delivery devices from Development to Manufacturing.
- Prepare and maintain process documentation, including process specifications, Process Maps, P-FMEAs, Product Concepts, and Manufacturing Concepts.
- Conceive prototypes and define critical process parameters.
- Communicate with the production site and schedule project-specific tasks.
- Identify optimization potential in existing production processes.
- Collaborate in defining processes at external suppliers.
- Provide technical support during root cause analysis and implementation of corrective actions.
- Create qualification plans and execute qualification activities.
Benefits
- Flexible working hours under a flextime model.
- 30 days of vacation per year.
- Company pension scheme.
- Public transport ticket subsidy.
- Pluxee prepaid card with monthly credit.
- Discounts through the Corporate Benefits and Benefits me apps.
- Regular company events.
- Attractive compensation and a wide range of additional benefits.
