Are you looking for a challenging role in research and development? We have an exciting opportunity for a Senior R&D Engineer to join our team.
About the Job:
The Senior R&D Engineer will be responsible for defining and documenting medical device development according to internal procedures and design control requirements. This will involve developing new product concepts, reviewing and defining new product and component requirements, and generating intellectual property.
Key Responsibilities:
* 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 specifications
* 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 as Product Interface Manager
* Support internal interfaces (Quality and Production department)
* Support material procurement and shipping requests
* Monitor suppliers concerning status of project and deal with technical issues
* Lead 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)
* Work closely in Cross Functional Team with both internal and external groups
* Support the preparation of budget proposals and assist in calculating costs of components and finished products
About You:
* Bachelor's degree or equivalent in bio-engineering or mechanical engineering discipline
* 7+ years of experience in a similar role
* Basic knowledge of technical drawing
* Basic knowledge of passive medical devices made from plastic materials
* Basic knowledge about plastic materials and relative manufacturing and assembly technologies
* DFSS (Design for Six Sigma)
* English level B1
* Minitab
* Basic knowledge in technical drawing and computation analysis (e.g., CFD, FEA)
* Microsoft Office suite (Excel, PowerPoint, Word)
Contact Information: