Senior Medical Device R&D Engineer - Scale-Up Impact

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

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.