Senior Medical Devices R&D Engineer required by Galway multinational to lead & develop a team of design & development engineers. Your team will be responsible for product development, qualification from market definition through production and release and will assist in the qualification of suppliers for new products to ensure suppliers deliver quality parts, materials, and services for new or improved manufacturing processes
Responsibilities:
- 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:
- Level 8 engineering, science or equivalent degree
- 5 to 8 year’s industry experience in a medical product development environment
- Proven track record of leading teams in device development
- Experience in coordinating and leading Design Reviews and the compilation of associated documentation
- 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
- Leading the team to carry out actions in accordance with the project plan and deliver projects through key milestone phases and associated activities
- 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: Travel: 10% to 25%
Please contact Emer Smith to discuss this urgent requirement in confidence
00353578638188
