- LocationCrema, Italy
-
IndustryMedical Device
THE COMPANY
Multinational Medical devices company
Senior R&D Engineer
THE ROLE
- 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 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 2 years of experience in the medical devices industry.
- Good communication skills.
- Good knowledge of the English language.
- Basic in technical drawing
- Basic knowledge about plastic materials and relative manufacturing and assembly technologies
- Basic knowledge of passive medical devices made in plastic materials.
- Basic knowledge about plastic materials and relative manufacturing and assembly technologies
LOCATION: Crema + 3 giorni di smart working alla settimana
Please send your CV with a motivation letter to the role to: [email protected]
Ref: Senior R&D Engineer
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