Development Engineer Product Compliance (m/f/d)
Machine translation — original language: German.Show original
Introduction
EPflex develops and produces high-tech instruments for minimally invasive medicine worldwide. As a second-generation medium-sized family business, we are among the pioneers of our industry with numerous patents and innovations. Our mission is to continually push the boundaries of minimally invasive medicine to enable shorter procedures, less pain, and faster healing for patients. We live this - with dedication, team spirit, and passion!
Tasks
- Determination of regulatory requirements for products and materials as well as ensuring conformity
- Creation and maintenance of development files
- Support of tests for design verification and validation as well as biocompatibility (from planning through execution to evaluation)
- Development and execution of necessary tests for product or material verification and validation
- Independent management and processing of compliance projects as well as participation in research cooperations
Profile
- Successfully completed degree in a science/technically oriented field (focus on medical technology, mechanical engineering, materials science, chemistry, or similar) or a comparable qualification
- Knowledge of REACh and in the approval of medical devices MDR&ISO 13485, 21CFR820, ISO 14971 is an advantage
- Conscientious and structured way of working paired with high problem-solving competence and commitment
- Proficient use of MS-Office
- Business fluent English in speaking and writing
We offer
- Permanent employment contract in a crisis-proof industry
- Flextime as well as the possibility for mobile working
- Financial support for specialist and further training
- Subsidy for capital-forming benefits
- Intensive induction & annual employee appraisals
- Flat hierarchies in a family-run company
- Modern office concept with ergonomic workstations
- JobBike leasing and attractive employee discounts
- Employee and company events
- Sports activities as well as cooperation with a gym
We look forward to receiving your application, stating your salary expectations and your earliest possible starting date.
Further information
EPflex Feinwerktechnik GmbH
Im Schwöllbogen 24 72581 Dettingen an der Erms https://www.epflex.com