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Senior R&D Engineer - Bardi, Italia - Antal International Network
Descrizione
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.
Release and review project documentation. 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 and internal procedures and DFSS (Design for Six Sigma).
Working closely in Cross Functional Team with both internal groups (Product Development, Regulatory, Manufacturing and Marketing) and external groups (Clinicians, Consultants, Regulatory).
Support the preparation of the budget. Provides assistance in calculating costs of component and finished product; propose and drives appropriate mitigation and contingency plan.JOB REQUIREMENTS Degree or similar education level in Bio-engineering or Mechanical engineering Minimum 5 years of experience in the medical devices industry.
Good knowledge of the English language.Good in technical drawing Good knowledge about plastic materials and relative manufacturing and assembly technologies Good knowledge of passive medical devices made in plastic materials.
Good knowledge about plastic materials and relative manufacturing and assembly technologies LOCATION:Crema (CR)
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