Senior Design Engineer Medical Devices Galway
A major medical devices manufacturing company in Galway is hiring a Senior Design Engineer
As part of the Design Engineering team, the Senior Design Engineer will lead and be an integral part of a team developing the Company's portfolio of platform delivery system products.
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 products.
An engineering, science or equivalent degree.
5 to 8 years 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 FMEAs, 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.
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.
Please send us your CV immediately to
or call Christy O'Hara on 087 94 73 404 for more information