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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