Senior R&D Engineer

Senior R&D Engineer

Fresenius Medical Care

Cremona, Italy

Tasks:

• Define and document medical devices development according to internal procedures and Design Control requirements;
• Develop new product concepts collecting and analyzing input from clinical, marketing, literature and other sources;
• Review and/or define new product and component requirements;
• Review and/or define new component specification;
• Develop test methods and equipment/fixtures;
• 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;
• Support Risk Manager in Risk management activities;
• Release and review project documentation;
• Generate intellectual property;
• Support Product Interface documentation release acting Product Interface Manager role;
• Support internal interfaces (Quality and Production department);
• Support material procurement and shipping requests;
• Monitoring of suppliers concerning status of project and dealing with technical issues;
• Leading 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);
• Working closely in Cross Functional Team with both internal and external groups;
• Support the preparation of the budget;
• Provides assistance in calculating costs of component and finished product; propose and drives appropriate mitigation and contingency plan.

Profile:

• Degree or similar education in bio-engineering/mechanical engineering discipline;
• 7+ years of experience in a similar role;
• Basic in technical drawing;
• Basic knowledge of passive medical devices made in plastic materials;
• Basic knowledge about plastic materials and relative manufacturing and assembly technologies;
• DFSS (Design for Six Sigma);
• English level B1;
• Minitab;
• Basic in technical drawing and computation analysis (es. CFD, FEA);
• Microsoft Office suite (Excel, Power Point, Word).

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