Overview
R&D Tech Lead / Staff Engineer – Medical Devices in Limerick. Full-time | Permanent. On-site: Monday to Thursday; Work from home: Fridays.
About The Role
We're hiring an experienced R&D Tech Lead / Staff Engineer to join a leading medical device company in Limerick. This role is central to the design, development, and commercialisation of life-changing healthcare technologies. You'll lead cross-functional engineering teams (HW, SW, UX, Systems) through the full product lifecycle—from concept to post-market support. The focus is on systems design, regulatory compliance, and technical leadership.
Key Responsibilities
* Drive system-level design for new and existing products
* Translate stakeholder needs into clear, traceable system requirements
* Lead integration and testing activities across disciplines
* Provide mentorship and technical direction across engineering functions
* Maintain and develop design control documentation, SOPs, and requirements using tools such as DOORS or Modern Requirements
* Lead change control and configuration management processes (e.g. CCB, CIT)
* Support regulatory submissions (FDA, ISO 13485, ISO 14971) in partnership with Quality and Regulatory teams
* Conduct risk assessments including dFMEA and hazard analysis
* Collaborate closely with Quality, Manufacturing, Marketing, and Regulatory to ensure smooth development and launch
* Develop Excel-based tools and workflows to support efficient documentation and project tracking
What We're Looking For
* 5+ years in product development, ideally in medical devices
* Strong background in systems engineering
* Proven track record of leading technical teams through phase-gate processes
* Skilled in writing SOPs, guidance docs, and technical documentation
* Experience in regulatory environments (ISO 13485, FDA QSR, ISO 14971)
* High proficiency in Microsoft Excel (incl. macros) and Microsoft Project
* Familiarity with tools such as DOORS, SolidWorks, MATLAB, LabVIEW, Minitab
* Strong communication and leadership skills
Nice to Have
* Bachelor’s or Master’s in Systems Engineering, Biomedical Engineering, or related
* Experience in configuration/change control systems
* Background working with complex multi-disciplinary systems
Why Apply?
* Work on cutting-edge healthcare technologies
* Join a highly skilled and collaborative R&D team
* Enjoy a hybrid work model with Fridays from home
* Be part of a company making a real impact in healthcare
* Excellent opportunity for career progression
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