Senior R&D Product Engineer
Location: Galway (On-site)
Employment Type: Permanent, Full-time
This is a pivotal opportunity for an experienced engineer to join a late-stage medical device start-up during a period of significant transition and growth. As the company moves to bring the development and manufacture of a device retrieval system from a third-party partner, you will play a central role in shaping the technical direction and operational success of this key product line. This role is ideally suited to an engineer who thrives in an entrepreneurial environment and enjoys the challenge of working across the full product lifecycle.
Role Overview
Reporting directly to the Senior R&D Manager, the Senior R&D Product Engineer will lead and support projects from initial concept through to regulatory approval and commercial scale-up. You will be responsible for the design, manufacture, and testing of innovative medical devices, ensuring that technical excellence is maintained throughout the transition to in-house production. This is a hands-on role requiring a blend of design expertise, process validation knowledge, and the ability to troubleshoot complex manufacturing issues in real-time.
Key Responsibilities
- Lead R&D projects through the complete development cycle, ensuring all milestones meet regulatory requirements for 510k and PMA submissions.
- Support Operations in sustaining and optimising manufacturing lines, focusing on production flow and process efficiency.
- Take ownership of real-time troubleshooting, including CAPA and NCR investigations, to maintain high quality standards.
- Manage the Design History File (DHF) and compile necessary documentation for EU MDR and ISO 13485 compliance.
- Partner with Quality and Operations teams to develop and execute robust validation protocols and reports.
- Provide technical guidance to external suppliers and mentor junior members of the engineering team.
Requirements
Essential:
- A degree in a relevant Engineering or Science discipline.
- A minimum of 5 years’ experience within the medical device industry.
- Proven track record in product and process validation, including design verification and validation (V&V).
- Proficiency in Solidworks or similar CAD software, backed by strong mechanical design fundamentals.
- Excellent technical writing and communication skills, with the ability to convey complex information to cross-functional teams.
- A flexible, proactive approach suited to a small-team, start-up environment.
Desirable:
- Experience with polymer-based delivery systems, catheters, or rigid/flexible endoscopes.
- Familiarity with medical device materials such as Nitinol and metallic introducers.
- In-depth knowledge of FDA CFR 820/QMSR and ISO 13485 standards.
- Demonstrated experience in project planning and execution.
What the Opportunity Offers
You will have the unique chance to lead the in-sourcing of a critical product kit, providing you with high visibility and the ability to influence the company’s manufacturing strategy. The role offers a technical challenge that spans prototyping to commercialisation, providing a breadth of experience rarely found in larger corporate structures. You will work within a collaborative, fast-paced culture that values technical autonomy and professional growth.
Application Process
If you are a motivated engineer looking to take the next step in your career within Galway’s thriving medtech hub, please submit your CV for consideration.
