Our client, an innovative blue-chip medical device manufacturer based in Ireland, are expanding their product portfolio to include a range of new products focused on delivery of minimally invasive medical devices.
Given this expansion, we are now actively recruiting for a Lead R&D Engineer who will be responsible for the design and develop of this next generation products.
The successful candidate will work within a dynamic New Product Development Team specialized in development of these cutting edge medical devices for commercialization in all major global healthcare markets.
This is a permanent role, based in Galway.
Responsibilities for Lead R&D Engineer:
- Develop a deep understanding of the disease state, gather user needs, and translate into technical specifications.
- Generate creative product solutions to address unmet needs.
- Develop test models for prototype performance evaluations.
- Build and test prototypes; analyse test data and interpret to identify optimal solution(s).
- Create detailed component and finished device assembly drawings/specifications.
- Identify and select product materials, assembly methods and define process settings.
- Develop and deliver project plans to performance, time and cost targets.
- Leverage and liaise with external resources to achieve project goals.
- Identify and manage of key risks throughout the product lifecycle.
- Write procedures, protocols, specifications, and reports.
- Evaluate and assess physician (user) techniques and develop product training materials.
- Develop marketing materials (presentations/videos/demos).
Requirements for Lead R&D Engineer:
- Bachelor's degree in Science, Engineering or equivalent Degree is required.
- 6+ years' experience in a similar / relevant device design & development role (including design with SolidWorks, prototyping, and testing) is desired.
- Leading the team to carry out actions in accordance with the project plan and deliver projects through key milestone phases and associated activities.
- Proven experience of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements.
- Proven experience in leading terms performing FMEAs, verifications and validations for medical devices products and processes.
- Experience with engineering tools such as DOE, SPC and using Minitab.
- 3D modelling experience.
Please contact Larry on +353 1 2302400 / email@example.com / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
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