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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
Connected Health IT Supply Chain Quality Assurance Manufacturing Executive Cork Mayo Life Science Pharma Sales Project Manager Dublin Quality Control Sales and Marketing Microbiology PhD Biotechnology Chemistry Scientific Academic Limerick Validation Engineer Supply Chain Medical Device Medical Affairs Laboratory Scientist Allied Healthcare Biopharmaceutical Sales and Marketing Packaging Engineer Diagnostics Cork City Pharmaceutical Academic Scientist Clinical Research Product Development Engineer Quality Engineering Engineering
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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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