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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

R&D Engineer


Reference:JCAO1601 Location: Galway
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: 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
What We’re Looking For

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
Education & Experience
  • 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