Entwicklungsingenieur / Engineer R&D Disposables Development

- 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