Our client, a medical device company in Galway are currently looking to recruit an R&D Engineer for their site.
The Design Engineer will be an integral part of a team developing a range of medical devices. This position requires a candidate with product development experience in the medical device arena, and one who will be comfortable operating as part of a team to develop our client?s products.
- Be an integral part of the team tasked with the development process from concept generation through to design verification.
- Apply new and existing technologies to provide the optimum delivery system design.
- Provide technical feedback during frequent technical contact with customers to optimise product design.
- Participate in trials with physicians to provide clinically relevant feedback on product designs.
- Support the maintenance of product files and other relevant documentation to comply with quality standards.
- Assist in the development of intellectual property generated by development activities.
- An engineering, science or equivalent degree.
- 2 to 5 year?s industry experience in a medical product development and/or manufacturing environment.
- Knowledge of minimally invasive Medical Device design, development and manufacturing. Ideally the candidate will have experience of working with catheter technology, catheter design and testing and catheter manufacturing.
- Working knowledge of catheter device materials including metals and polymers, knowledge of biocompatibility requirements an advantage.
- The ideal candidate will have relevant experience working with project teams in planning and executing project plans and delivering projects through key milestone phases and associated activities.
- Experience with engineering tools such as DOE and SPC, and ideally experience using Minitab.
- 3D modeling experience.
- 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.
- Knowledge of biocompatibility, Sterilization validations, packaging/transportation validations an advantage.
- Availability to participate in limited travelling to meet with customers to conduct scheduled reviews.
- Proven track record of excellent time keeping & attendance is essential.
For further information on this R&D Engineer role in Galway please contact Nicola O?Connell on 091730022 / firstname.lastname@example.org
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