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Details
R&D Engineer
| Reference: | JCAO1601 | Location: |
Galway |
| Qualification: | Degree | Experience: | 3-4 Years |
| Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
Research and Development, Research and Development Engineer
R&D Engineer
📍 Galway, Ireland | On-site
An exciting opportunity has arisen to join a high-growth medical device company developing a next-generation device. This role will play a key part in taking a novel therapy from design and verification through clinical trials and regulatory approval, with a primary focus on the delivery system and associated sub-components.
The Role
As an R&D Engineer, you will work within a cross-functional team to design, develop and test components of a cutting-edge system, ensuring performance, safety and quality throughout the product lifecycle. This position is based on-site in the Galway R&D centre and reports to the Head of R&D.
Key Responsibilities
- Contribute to the design and development of a novel transcatheter heart repair device aligned with user and clinical needs
- Lead component-level design activities, including detailed drawings, specifications and peer reviews
- Develop device specifications and generate creative, data-driven engineering solutions
- Use SolidWorks to review, import and optimise CAD models
- Build analytical and computational models to predict in-vivo device performance
- Source, build and test prototypes; analyse and interpret data to drive design decisions
- Develop and execute verification and validation test methods
- Prepare clear technical reports and presentations for internal stakeholders
- Drive risk management activities and support system-level risk-based design
- Generate technical documentation for the Design History File (DHF) and Device Master Record (DMR)
- Ensure designs meet requirements for durability, usability, reliability, manufacturability and patient safety
- Support clinical validation activities and, where required, clinical cases and physician proctoring
Essential Requirements
- Strong engineering fundamentals applied to medical device development, ideally within cardiovascular devices
- Experience working in a regulated environment (medical devices preferred)
- Data-driven approach to problem solving and technical decision-making
- Ability to manage own workload, timelines and development budgets
- Excellent written and verbal technical communication skills
- Collaborative mindset with the confidence to take initiative and challenge decisions when required
- Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering or related discipline
- 2–3+ years’ experience developing Class III medical devices, ideally involving clinical trials
- Experience with delivery systems or delivery sheaths is highly advantageous
- Knowledge of materials and processes including Nitinol, fatigue analysis, metallurgy and strength of materials
- Understanding of in-vitro and in-vivo device performance and implant–tissue interaction
- Proficiency in SolidWorks or similar CAD tools
- Working knowledge of FDA, GMP, QSR and ISO 13485
- Experience preparing technical and regulatory documentation
For further information please contact James Cassidy [email protected] or call in confidence 086 0204322
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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