Lead Medical Device R&D Engineer

Freudenberg; Carrick-on-Shannon; On-site; EUR 65,000 - 90,000; Full time

Job summary

Freudenberg Medical Ireland Ltd. is seeking an experienced engineer to lead the design and development of complex medical devices from concept through design freeze.

The role requires expertise in catheter systems, extrusion-based assemblies, and biomaterials, with emphasis on regulatory compliance. The candidate should hold a bachelor's degree in engineering or science and possess at least 4 years of relevant experience, along with strong collaboration and communication skills to work across

Qualifications

• Bachelor degree in Mechanical, Biomedical, or related field.
• 4+ years of relevant experience for senior role.
• Strong interpersonal and communication skills across teams.

Responsibilities

• Lead design and development of complex medical devices from concept to design freeze.
• Verify and validate protocols (IQ/OQ/PQ) in compliance with ISO 13485 and FDA 21 CFR Part 820.
• Manage cross-functional technical projects balancing design intent, manufacturability, and regulatory needs.
• Lead FMEA, risk analysis, and root-cause investigations for robust design and processes.
• Mentor junior engineers and provide technical reviews to build team capability.
• Develop and maintain DHFs, BOMs, drawings, and test reports per QMS requirements.
• Engage with customers to understand application needs and lead design iterations.

Skills

Mechanical Engineering

Biomedical Engineering

Project management

Design for manufacturability

Regulatory knowledge

Education

Bachelor’s degree in Science/Engineering

Job description

Freudenberg Medical Ireland Ltd. is seeking an experienced engineer to lead the design and development of complex medical devices from concept through design freeze.

The role requires expertise in catheter systems, extrusion-based assemblies, and biomaterials, with emphasis on regulatory compliance. The candidate should hold a bachelor's degree in engineering or science and possess at least 4 years of relevant experience, along with strong collaboration and communication skills to work across