Description
One of the most innovative and advanced medical device manufacturing companies in the business, based in Galway, are currently recruiting for a Senior Design Services Engineer as part of their expansion plan and large projects within Design Services.This is an excellent opportunity to join a fantastic company on an full time basis with a very competitive salary on offer. This position requires a candidate with significant product development experience in the medical device arena, and one who will be comfortable leading and developing a team to develop.
Major Accountabilities:
- 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.
Requirements:
- 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 travelling to meet with customers to conduct scheduled reviews.
If you are interested in hearing more about this exciting opportunity please apply directly to this advert or call Derek Sheridan on for further information.