Senior R&D Product Engineer

Life Science Recruitment; Galway; On-site; EUR 65,000 - 90,000; Full time

Job summary

Life Science Recruitment is seeking a Senior R&D Product Engineer for a Galway-based, on-site permanent role within a late-stage medical device start-up. You will lead projects across the full product lifecycle, driving development, validation, and manufacturing improvements in a fast-growing, entrepreneurial team.

Key responsibilities include directing 510(k)/PMA regulatory processes, maintaining DHF, and mentoring junior engineers, with emphasis on cross-functional collaboration and strong

Qualifications

• 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.

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.

Skills

Technical writing

Communication

Mechanical design

Education

Engineering or Science degree

Tools

SolidWorks

Job description

Senior R&D Product Engineer

Location: Galway (On-site)

Employment Type: Permanent, Full-time

Role Overview

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.

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 companys 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.