R&D Tech Lead / Staff Engineer

R&D Tech Lead / Staff Engineer – Medical Devices

📍 Limerick

🕒 Full-time | Permanent

Work Model

• 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

Interested?

Apply now or get in touch to learn more.

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