9/11/2025 A) R&D Tech Lead

6 days ago

Limerick, Limerick, Ireland CPL Full time
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.

#LI-DB4

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