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 Role
You'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 device
* Create detailed drawings and specifications; participate in design reviews
* Develop device specifications aligned with user and clinical needs
* Build and test prototypes; analyse data to drive design decisions
* Develop and execute verification and validation test methods
* Use SolidWorks to review and optimise CAD models
* Support risk management activities and system-level design decisions
* Generate technical documentation (DHF, DMR) in line with regulatory requirements
* Support clinical validation activities and, where required, clinical cases
* Degree in Mechanical or Biomedical Engineering (or similar)
* 2–3+ years' experience developing Class III medical devices, ideally cardiovascular
* Experience with delivery systems / delivery sheaths highly desirable
* Strong understanding of materials, manufacturing processes and mechanical design
* Knowledge of Nitinol, fatigue analysis and implant–tissue interaction advantageous
* Experience working in a regulated environment (FDA, GMP, ISO 13485)
* Proficiency in SolidWorks
* Strong communication, organisation and problem-solving skills
* Work on a life-changing structural heart technology
* High-impact role across design, testing and clinical translation
* Excellent 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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