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

• 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