Senior R&D Engineer

• 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 820.30) 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)

Please send your CV with a motivation letter to the role to: matteo.boscarello@antal.com

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