Senior Research & Development 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

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). 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.

VistaMed Ltd. Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications. Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.