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An exciting opportunity to join a leading medical device company as a Senior R&D Engineer. As part of the R&D Engineering team, the Senior R&D Engineer will lead and be an integral part of a team developing a portfolio of products. This role will report to the Senior R&D Manager. For more details please contact me.
- 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 optimize product design.
- Support the maintenance of product files and other relevant documentation to comply with quality standards.
- Compile project plans and lead the team to develop devices in accordance with planned activities, budget, and timelines.
- An 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 of 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 modeling experience.
- Working knowledge of biocompatible metal and/or polymer materials.
- Demonstrate a working knowledge of the required activities and deliverables from each of the development phases.
- Availability to participate in limited traveling to meet with customers to conduct scheduled reviews.
*Excellent Salary & Benefits.
For a confidential discussion and more information on this role, please contact Nicola Walsh.