We’re partnering with an innovative medical device company developing a next-generation therapy. This is a fantastic opportunity for an R&D Engineer to play a key role in taking a Class III cardiovascular device from design through clinical trials and regulatory approval. The RoleYou’ll work as part of a highly collaborative R&D team, with primary responsibility for the design, development and testing of the delivery system and related components. This role is based on-site in the Galway R&D centre and reports to the Head of R&D.Design and develop components for a novel transcatheter heart repair deviceCreate detailed drawings and specifications; participate in design reviewsDevelop device specifications aligned with user and clinical needsBuild and test prototypes; analyse data to drive design decisionsDevelop and execute verification and validation test methodsUse SolidWorks to review and optimise CAD modelsSupport risk management activities and system-level design decisionsGenerate technical documentation (DHF, DMR) in line with regulatory requirementsSupport clinical validation activities and, where required, clinical casesDegree in Mechanical or Biomedical Engineering (or similar)2–3+ years’ experience developing Class III medical devices, ideally cardiovascularExperience with delivery systems / delivery sheaths highly desirableStrong understanding of materials, manufacturing processes and mechanical designKnowledge of Nitinol, fatigue analysis and implant–tissue interaction advantageousExperience working in a regulated environment (FDA, GMP, ISO 13485)Proficiency in SolidWorksStrong communication, organisation and problem-solving skillsWork on a life-changing structural heart technologyHigh-impact role across design, testing and clinical translationExcellent opportunity for technical growth within a fast-moving MedTech environment Interested or know someone suitable?Apply directly or message me for a confidential discussion.
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