R&D Tech Lead / Staff Engineer – Medical DevicesWork ModelOn-site: Monday to Thursday Work from home: FridaysAbout the RoleWe'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 ResponsibilitiesDrive system-level design for new and existing productsTranslate stakeholder needs into clear, traceable system requirementsLead integration and testing activities across disciplinesProvide mentorship and technical direction across engineering functionsMaintain and develop design control documentation, SOPs, and requirements using tools such as DOORS or Modern RequirementsLead change control and configuration management processes (e.g. CCB, CIT)Support regulatory submissions (FDA, ISO 13485, ISO 14971) in partnership with Quality and Regulatory teamsConduct risk assessments including dFMEA and hazard analysisCollaborate closely with Quality, Manufacturing, Marketing, and Regulatory to ensure smooth development and launchDevelop Excel-based tools and workflows to support efficient documentation and project trackingWhat We\'re Looking For5+ years in product development, ideally in medical devicesStrong background in systems engineeringProven track record of leading technical teams through phase-gate processesSkilled in writing SOPs, guidance docs, and technical documentationExperience in regulatory environments (ISO 13485, FDA QSR, ISO 14971)High proficiency in Microsoft Excel (incl. macros) and Microsoft ProjectFamiliarity with tools such as DOORS, SolidWorks, MATLAB, LabVIEW, MinitabStrong communication and leadership skillsNice to HaveBachelor’s or Master’s in Systems Engineering, Biomedical Engineering, or relatedExperience in configuration/change control systemsBackground working with complex multi-disciplinary systemsWhy Apply?Work on cutting-edge healthcare technologiesJoin a highly skilled and collaborative R&D teamEnjoy a hybrid work model with Fridays from homeBe part of a company making a real impact in healthcareExcellent opportunity for career progressionInterested?Apply now or get in touch to learn more.
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