Senior Research And Development Engineer

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

Job summary

Life Science Recruitment in Galway is seeking a Senior R&D Product Engineer to join a late-stage medical device start-up. You will drive the development of a device retrieval system in-house, bridging R&D and operations, and ensure scale-up and regulatory readiness.

The role focuses on design, development, and manufacture of medical devices within a cross-functional team, with emphasis on manufacturability and compliance with ISO 13485, EU MDR, and FDA PMA/510k.

Qualifications

• 5+ years in medical device engineering.
• Strong mechanical design background.
• Proficient in SolidWorks.
• Experience in design verification and process validation.

Responsibilities

• Drive R&D projects from prototyping through regulatory approval and commercial launch.
• Manage process and product validation activities, including protocols and reports.
• Lead NCR and CAPA investigations to resolve issues.
• Ensure documentation complies with ISO 13485, EU MDR, and FDA PMA/510k.
• Provide technical support to supply chain and coach junior staff.

Skills

Mechanical design

Design verification

Process validation

Communication

Education

Degree in Engineering or Science

Tools

SolidWorks

Job description

Are you an experienced Product Engineer looking to make a tangible impact on a product’s journey from concept to commercialisation? We are currently seeking a Senior R&D Product Engineer to join a late-stage medical device start-up in Galway. This is a hands-on role where you will be instrumental in bringing the development of a device retrieval system in-house, working closely with the Senior R&D Manager to ensure a seamless transition and successful scale-up.

Role Overview

The successful candidate will be responsible for the design, development, and manufacture of medical devices within a cross-functional team. You will bridge the gap between R&D and Operations, ensuring that products are not only designed to the highest standard but are also manufacturable and compliant with international regulatory bodies. This role involves significant work in troubleshooting, CAPA management, and the maintenance of comprehensive Design History Files.

Key Responsibilities

• - Driving R&D projects from initial prototyping through to regulatory approval and commercial launch.
• - Managing process and product validation activities, including the creation of protocols and reports.
• - Leading NCR and CAPA investigations to resolve manufacturing and design issues.
• - Ensuring all documentation complies with ISO 13485, EU MDR, and FDA requirements (PMA/510k).
• - Providing technical support to the supply chain and coaching junior engineering staff.

Required Experience

• - Minimum of 5 years in medical device engineering.
• - Strong background in mechanical design and proficiency in Solidworks.
• - Extensive experience in design verification and process validation.
• - Degree-qualified in a relevant Engineering or Science field.
• - Ability to work effectively in a flexible, fast-paced start-up environment.
• - Excellent communication skills, both written and verbal.

Why Consider This Role?

This position offers the chance to own the technical transition of a product line from a third-party manufacturer to an in-house facility. It is a rare opportunity to gain exposure to the full product lifecycle in a late-stage start-up that is scaling rapidly. If you enjoy technical variety and want to be part of a team where your contributions are immediately visible, this is the ideal career move.