Senior Research And Development Engineer

Relocation Required: Galway, Ireland, Hybrid OnsiteTitle: Senior R&D Engineer – Catheter Technology (Medical Devices)Location: Galway, Ireland (On-site with limited remote work) – Relocation required Employment Type: Full-TimeRole Overview:We are seeking a Senior Research & Development Engineer to join a physician-focused, innovation-driven medical device team. This role offers the opportunity to contribute across the entire product development lifecycle, from early prototyping through design verification, process validation, and design transfer into production. You will play a critical part in shaping the next generation of catheter-based technologies.Key Responsibilities:• Lead and contribute to design verification, validation, and process validation activities.• Develop and document lab testing protocols, risk assessments, and technical files.• Drive projects through major milestones including design freeze, verification, and transfer phases.• Oversee prototype builds, high-volume testing, and data generation to support regulatory submissions.• Analyze test results, review test plans, and guide iterative design improvements.• Collaborate cross-functionally with engineering, quality, regulatory, and manufacturing partners to ensure readiness for approval and commercialization.• Provide hands-on technical problem-solving and testing in the lab environment.• Support external manufacturing partners while maintaining strong in-house technical execution.Must-Have Qualifications & Experience:• Proven experience across the full medical device development lifecycle.• Strong foundation in catheter design, prototyping, and troubleshooting (or similar minimally invasive devices).• Hands-on experience with test method development, execution, and results analysis.• Skilled in documentation creation, report writing, and regulatory submission input.• Proficient in data analysis and test plan review, with ability to communicate technical findings clearly.• Experience working directly with R&D teams in a biomedical or medical device environment.• Proactive, self-starting engineer with strong collaboration and problem-solving skills.Desirable Skills:• Proficiency in SolidWorks for design and development.• Experience using document management systems (e.g., Windchill).• Knowledge of statistical tools such as Minitab.• Previous exposure to neurovascular, cardiovascular, or catheter-based devices.• Background in innovation-focused R&D environments (start-up or large medtech).Ideal Background:• Bachelor’s or Master’s degree in Mechanical, Biomedical, or related Engineering field.• Minimum of 4 years’ experience in medical device design and development.• Track record of success in cross-functional collaboration, balancing independent execution with team alignment.Why Join?• Contribute to cutting-edge catheter R&D addressing unmet clinical needs.• Be part of a high-impact project influencing clinical and regulatory outcomes.• Thrive in a collaborative, dynamic environment with direct physician engagement.• Gain technical variety, career growth, and innovation opportunities in a role at the core of medical device development.