Senior Medical Device R&D Engineer Lead In-Sourcing Galway

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

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