- Full-time - Permanent - Mobile working partly possible -
For our Research & Development team we are looking for an Engineer for the new and further development of product designs in the field of disposable medical devices.
Main responsibilities
- Development and design of disposable medical devices and their components
- Project collaboration in interdisciplinary teams (product management, QM, RA) Collaboration with external production sites and external manufacturing partners regarding requirements gathering, request for quotation, technical coordination
- Development of product requirements with product management & implementation in standard-compliant solutions
- Support in the planning, execution & documentation of experimental tests and design verification (functionality, reliability, regulatory requirements)
- Preparation of technical documentation according to MDR / ISO 13485. Support of regulatory affairs and QM: technical file, customer specifications, product registration, product changes, risk analyses (FMEA)
Experience and qualifications
- Completed studies in the field of medical technology, plastics technology or a comparable engineering discipline
- Professional experience in dealing with medical technology products, product development and their regulatory requirements
- Knowledge of plastics (material selection, manufacturing processes e.g. injection molding/extrusion)
- Knowledge of project management
- Very good written and spoken German and English skills
- Independent and structured way of working as well as ability to work in a team and sense of responsibility
- Communication skills and willingness to travel