Senior Research & Development Engineer

Freudenberg Group; Carrick-on-Shannon; On-site; EUR 60,000 - 95,000; Full time

Job summary

Freudenberg Group in Ireland seeks an experienced design engineer to lead the development of complex medical devices from concept to design freeze, applying advanced materials knowledge and precision manufacturing.

You will act as SME for catheter systems and biomaterials, drive verification/validation per ISO 13485 and FDA rules, and mentor junior engineers while collaborating across functions.

Qualifications

• Engineering or science degree, preferably mechanical or biomedical.
• SolidEdge CAD experience preferred.
• 4+ years of relevant senior-level experience.

Responsibilities

• Lead design and development of complex medical devices from concept to design freeze.
• Solve high-level engineering challenges using advanced materials, precision manufacturing, and data-driven decisions.
• Act as SME in catheter systems, extrusion-based assemblies, and biomaterials.
• Develop and execute IQ/OQ/PQ verification & validation with ISO 13485 and FDA 21 CFR Part 820 compliance.
• Manage cross-functional technical projects balancing design, manufacturability, and regulatory requirements.
• Lead FMEA, risk analysis, and root-cause investigations.
• Provide technical mentoring and reviews for junior engineers.
• Drive innovation through emerging technologies, novel components, automation.
• Maintain DHFs, BOMs, drawings, test reports per QMS.
• Engage with customers to understand needs and lead design iterations.

Skills

CAD

Solid Edge

Cross-functional collaboration

Education

Bachelor's degree in Mechanical Engineering or Biomedical Engineering or related discipline

Job description

Working at Freudenberg: We will wow your world!

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

Qualifications:

• Third-level qualification in Engineering or Science, preferably Mechanical or Biomedical; minimum Bachelor’s degree in Science, Technology, Engineering, or a related discipline (Mechanical, Manufacturing, Automation, or equivalent).

• 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

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.