Fresenius Medical Care is the world’s leading provider of products and services for dialysis by offering innovative products and treatment concepts of the highest quality. We continuously want to improve the quality of life for our dialysis patients, worldwide and every day.
Our manufacturing plant in Palazzo Pignano specializes in producing bloodlines, operating around the clock with a dedicated workforce of more than 550 employees. Within this dynamic setting, our R&D departments play a pivotal role, ensuring that components and medical devices are correctly developed as per projects assigned in compliance with applicable regulations and internal procedures.
Tasks:
1. Define and document medical devices development according to internal procedures and Design Control requirements.
2. Develop new product concepts collecting and analyzing input from clinical, marketing, literature and other sources.
3. Review and/or define new product and component requirements.
4. Review and/or define new component specifications.
5. Develop test methods and equipment/fixtures.
6. Coordinate technical team for the realization and preparation of bill of materials, verification of adequate components availability, verification of supplier capacity, coordination with production to evaluate feasibility.
7. Support Risk Manager in risk management activities.
8. Release and review project documentation.
9. Generate intellectual property.
10. Support Product Interface documentation release acting as Product Interface Manager.
11. Support internal interfaces (Quality and Production department).
12. Support material procurement and shipping requests.
13. Monitor suppliers concerning status of project and deal with technical issues.
14. Lead Product Development activities according to referenced standards (ISO 13485, ISO 14971, FDA 21 CFR 820.30) and internal procedures and DFSS (Design for Six Sigma).
15. Work closely in Cross Functional Team with both internal and external groups.
16. Support the preparation of the budget.
17. Provide assistance in calculating costs of component and finished product; propose and drive appropriate mitigation and contingency plans.
Profile:
1. Degree or similar education in bio-engineering/mechanical engineering discipline.
2. 7+ years of experience in a similar role.
3. Basic knowledge in technical drawing.
4. Basic knowledge of passive medical devices made from plastic materials.
5. Basic knowledge about plastic materials and relative manufacturing and assembly technologies.
6. DFSS (Design for Six Sigma).
7. English level B1.
8. Minitab.
9. Basic knowledge in technical drawing and computation analysis (e.g., CFD, FEA).
10. Microsoft Office suite (Excel, PowerPoint, Word).
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