A permanent opportunity has arisen with an advanced Medical Device start up in Galway. They are looking to hire an R&D Engineer to join their team on a permanent basis.
This role provides key R&D Engineering support to the Product Development function in developing and sustaining products, processes, materials requirements and equipment in order to achieve design brief.
- Technical support to projects leads for both new and transfer products in compliance to internal procedures including EU and FDA requirements from Concept phase through design freeze, verification, and validation and finally into commercialization phase
- Interact with product stakeholders (e.g. external vendors, operations, quality, regulatory etc.) to identify opportunities and develop appropriate strategies to ensure design specifications are met
- Support with Component/assembly design, modification and preparation of associated drawings and specifications
- Support product design, building and testing
- Assist in the development and execution of design verification and validation protocols
- Investigate, evaluate, and aid in the selection of product materials
- Support test method development; identification and procurement of equipment for inspection and test, test method validation
- Generation, analysis and interpretation of test data
- Contribute to resolution of technical challenges with existing and new designs
- Support in developing and delivering project plans to performance, time and cost targets
- Support in preparation of risk management files including Use and Design FMEAs
Skills, Qualifications & Experience
- Mechanical or Biomedical engineering degree or equivalent.
- 2+ years’ experience in medical device design/development or sustaining engineering role in a medical device company.
- Strong technical aptitude with a good understanding of fundamental engineering principals and materials.
- Broad knowledge of materials and processes used in medical devices. Background in catheter design and manufacturing a distinct advantage.
- Experience in change control management; design, process and system.
For a more detailed job specification or confidential discussion on this role contact Amy Newell.