Senior R&D Engineer – Product Development
Job ID: JOB-11404
Senior R&D Engineer – Product Development
My MNC Medical Device Client are ranked among the top 10 global companies in the medical device outsourcing industry. The company specializes in the design and manufacture of minimally invasive delivery and access devices for a range of therapies and are searching for a Senior R&D Engineer to lead and be an integral part of a team developing the company’s portfolio of platform delivery system products.
This role requires you to have significant product development experience in the medical device arena and be be comfortable leading and developing a team to develop Creganna’s products. You will report to the Group Leader and be based at HQ in Galway.
As a part of the R&D/Product Development Engineering Team you will conceive original ideas for new products and introduce them into practice. You will be responsible for product development, and qualification from market definition through production and release; assist in the qualification of suppliers for new products to ensure suppliers deliver quality parts, materials, and services for new or improved manufacturing processes; conduct feasibility studies, testing on new and modified designs; direct and support detailed design, testing, prototype fabrication and manufacturing ramp.
- Lead and be an integral part of the team tasked with the development process from concept generation through to design verification
- Assist in the development of intellectual property generated by development activities
- Ensure the application of new and existing technologies to provide the optimum delivery system design
- Participate in trials with physicians to provide clinically relevant feedback on product designs
- Provide technical feedback during frequent technical contact with customers to optimise product design
- Support the maintenance of product files and other relevant documentation to comply with quality standards
- Compile project plans and lead team to develop devices in accordance with planned activities, budget and timelines
Qualifications & Requirements
- Level 8 Engineering, science or equivalent degree
- 5 to 8 Year’s Industry Experience in a medical product development environment with a proven track record of leading teams in device development
- Experience in coordinating and leading Design Reviews and the compilation of associated documentation
- Leading the team to carry out actions in accordance with the project plan and deliver projects through key milestone phases and associated activities
- Demonstrate a thorough knowledge and understanding of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements
- Proven experience of minimally invasive Medical Device design, development and manufacturing
- Proven experience in leading teams performing FMEA’s, verifications and validations for medical devices products and processes. Knowledge and experience with Medical Device sterilisation processes, specifically gamma and EtO sterilisation
- Proven experience of work with catheter technology, catheter design and testing and catheter manufacturing a distinct advantage
- Experience with engineering tools such as DOE, SPC, and using Minitab
- 3D modelling experience
- Working knowledge of biocompatible metal and/or polymer materials
- Annual bonus
- Health insurance
- Life Assurance
- Christmas bonus voucher
- Paid holidays
- Free parking & overflow carpark
- Subsidised canteen
- Sports & Social membership
- Training & development opportunities
- Educational Assistance
For further information on this Senior R&D Engineering role in Galway please contact Amanda Reynolds on 0860468858 or firstname.lastname@example.org
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