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
