R&D Tech Lead / Staff Engineer – Medical Devices
Limerick
Full-time | Permanent
Work Model
1. 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
2. Drive system-level design for new and existing products
3. Translate stakeholder needs into clear, traceable system requirements
4. Lead integration and testing activities across disciplines
5. Provide mentorship and technical direction across engineering functions
6. Maintain and develop design control documentation, SOPs, and requirements using tools such as DOORS or Modern Requirements
7. Lead change control and configuration management processes (e.g. CCB, CIT)
8. Support regulatory submissions (FDA, ISO, ISO ) in partnership with Quality and Regulatory teams
9. Conduct risk assessments including dFMEA and hazard analysis
10. Collaborate closely with Quality, Manufacturing, Marketing, and Regulatory to ensure smooth development and launch
11. Develop Excel-based tools and workflows to support efficient documentation and project tracking
What We're Looking For
12. 5+ years in product development, ideally in medical devices
13. Strong background in systems engineering
14. Proven track record of leading technical teams through phase-gate processes
15. Skilled in writing SOPs, guidance docs, and technical documentation
16. Experience in regulatory environments (ISO, FDA QSR, ISO )
17. High proficiency in Microsoft Excel (incl. macros) and Microsoft Project
18. Familiarity with tools such as DOORS, SolidWorks, MATLAB, LabVIEW, Minitab
19. Strong communication and leadership skills
Nice to Have
20. Bachelor's or Master's in Systems Engineering, Biomedical Engineering, or related
21. Experience in configuration/change control systems
22. Background working with complex multi-disciplinary systems
Why Apply?
23. Work on cutting-edge healthcare technologies
24. Join a highly skilled and collaborative R&D team
25. Enjoy a hybrid work model with Fridays from home
26. Be part of a company making a real impact in healthcare
27. Excellent opportunity for career progression
Interested?
Apply now or get in touch to learn more.
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