R&D/Product Development Engineer I
Our client, a medical device company in Galway are currently looking to recruit a R&D/Product Development Engineer I for their site.
- Be an integral part of the team tasked with the development process from concept generation through to device design and development with a specific focus on Tooling and Fixture Design.
- Liaise with the development teams to provide direction and advice on device assembly challenges.
- Create new design solutions or leverage existing designs to create cost effective and efficient improvements to assembly challenges.
- Develop fully detailed Specifications for tooling and fixturing according to Company standards.
- Communicate and manage manufacture of fixturing with tooling manufacturers.
- Liaise with the development teams to provide direction and advice on their tooling requirements.
- Support the maintenance of specifications and other relevant documentation to comply with quality standards.
- Contribute to Product design activities
- Assist in the development of intellectual property generated by development activities.
- A Mechanical Engineering or equivalent degree.
- A high skill level using Solidworks 3D modelling software.
- 2 to 5 years in a mechanical design environment preferably in a medical device design environment, with exposure to product design and Fixture design.
- A working Knowledge of minimally invasive Medical Device design, development and manufacturing processes.
- The ideal candidate will have skills in tooling and jig and Fixture design.
- Design of injection moulded and machined components is desirable
- Must have relevant experience working with project teams in planning and executing project plans and delivering projects through key milestone phases and associated activities.
- Experience of participating in Design Reviews and the compilation of associated documentation, including:
- A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements.
- Experience in working with teams on compilation of FMEA, design verification and validations protocols and reports.
- Availability to participate in limited travelling to meet with customers to conduct scheduled reviews.
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