Senior Product Development Engineer – Galway
An exciting opportunity for an experienced engineer to join a market leading Medical Device multinational based in Galway. You will lead a team in the development of processes for medical device products.
- Lead development process from concept generation through to design verification.
- Assist in the development of intellectual property.
- 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.
- Provide technical feedback during frequent technical contact with customers.
- Support the maintenance of product files and other relevant documentation.
- Compile project plans and lead team to develop devices in accordance with plans.
- BSc. in Engineering, Science or equivalent degree.
- 5-8 year industry experience in a medical product development environment.
- Experience in coordinating and leading Design Reviews.
- Leading the team to carry out actions in accordance with the project plan.
- 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.
- Proven experience of work with catheter technology advantageous.
- Experience with engineering tools such as DOE, SPC, and Minitab.
- 3D modelling experience.
- Working knowledge of biocompatible metal and/or polymer materials.
- Some travel required.
- Must be authorised to work in Ireland.
Please contact Emer Moore to discuss in confidence