Senior Medical Device R&D Engineer – Catheter Systems

Freudenberg Group; Carrick-on-Shannon; On-site; EUR 70,000 - 100,000; Full time

Job summary

Freudenberg Group is seeking a senior engineering professional to lead the design and development of complex medical devices from concept to design freeze. You will solve high-level engineering challenges, act as the SME for catheter systems and biomaterials, and guide technical standards.

The role requires delivering IQ/OQ/PQ verification and validation, managing cross-functional projects, and mentoring junior engineers.

Qualifications

• Third-level qualification in Engineering or Science; Mechanical or Biomedical preferred.

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

Interpersonal skills

Communication skills

Team collaboration

Education

Bachelor’s degree in Science, Technology, Engineering, or related discipline

Tools

Solid Edge

Job description

Freudenberg Group is seeking a senior engineering professional to lead the design and development of complex medical devices from concept to design freeze. You will solve high-level engineering challenges, act as the SME for catheter systems and biomaterials, and guide technical standards.

The role requires delivering IQ/OQ/PQ verification and validation, managing cross-functional projects, and mentoring junior engineers.