- Reference: GJ42549
- Job Type: Permanent
- Location: Galway, Mayo, Westmeath
- Category: Engineering, Technical & Manufacturing
As part of the Design Services Engineering team at our Parkmore facility 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 clients products. She/he will report to the Group Leader, and the position will be based in our Parkmore facility.
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.
- 4 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 a confidential discussion and more information on the role/company please contact Christopher O Toole on 091-706713 or email email@example.com
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