Senior Medical Device R&D Engineer — Catheter Systems

freudenberg; Carrick-on-Shannon; On-site; EUR 60,000 - 90,000; Full time

Job summary

Freudenberg Group in Ireland seeks a senior engineer to lead the design and development of complex medical devices from concept through to design freeze. You will solve advanced engineering problems using materials knowledge, precision manufacturing, and data-driven decisions, acting as SME for catheter systems and biomaterials.

Expect cross-functional leadership and mentoring across teams. You will develop and execute IQ/OQ/PQ validation protocols to ensure ISO 13485 and FDA 21 CFR Part 820

Qualifications

• Third-level qualification in Engineering or Science, preferably Mechanical or Biomedical; minimum Bachelor's degree in related discipline.
• Proven design capability with CAD systems, ideally Solid Edge.
• Senior-level candidates should have a minimum of 4 years' relevant experience.
• Excellent interpersonal and communication skills, with the ability to collaborate effectively across teams.

Responsibilities

• Leads the design and development of complex medical devices from concept through to design freeze.
• Solves high-level engineering challenges using advanced materials knowledge, precision manufacturing methods, and data-driven decision making.
• Acts as a subject matter expert in catheter systems, extrusion-based assemblies, and biomaterials, influencing design direction and technical standards.
• Develops and executes verification and validation protocols (IQ/OQ/PQ), ensuring compliance with ISO 13485 and FDA 21 CFR Part 820.
• Manages cross-functional technical projects, balancing design intent, manufacturability, and regulatory requirements.
• Leads FMEA, risk analysis, and root cause investigations to ensure robust design and process outcomes.
• Provides technical mentoring and reviews for junior engineers and project teams, helping to build capability and ensure knowledge transfer.
• Drives innovation by exploring emerging technologies, novel components, and automation opportunities.
• Develops and maintains detailed documentation including DHFs, BOMs, drawings, and test reports in compliance with QMS requirements.
• Engages directly with customers to understand application needs, presenting technical solutions and leading design iterations.

Skills

CAD Solid Edge

Engineering design

Cross-functional collab

Documentation & QA

Education

Bachelor's degree in STEM

Tools

Solid Edge

Job description

Freudenberg Group in Ireland seeks a senior engineer to lead the design and development of complex medical devices from concept through to design freeze. You will solve advanced engineering problems using materials knowledge, precision manufacturing, and data-driven decisions, acting as SME for catheter systems and biomaterials.

Expect cross-functional leadership and mentoring across teams. You will develop and execute IQ/OQ/PQ validation protocols to ensure ISO 13485 and FDA 21 CFR Part 820