Research And Development Engineer

R&D Engineer – Catheter Medical Devices Relocation RequiredWe are supporting an established medical device organisation in the search for a Senior R&D Project Manager to lead the development of advanced catheter-based medical devices from concept through to commercialization.This is a senior technical and leadership position for someone with deep catheter development/manufacturing expertise who wants to take ownership of complex R&D programs and help drive new product innovation.The RoleYou will act as a key technical and project authority within R&D, leading multiple medical device development programs while working closely with Quality, Regulatory, Manufacturing and Commercial teams.Key responsibilities include:

• Lead catheter and medical device development from concept to commercialization
• Own complex R&D projects across timelines, budgets, resources and technical deliverables
• Drive design, material selection, prototyping, testing and validation activities
• Lead design reviews, FMEA, risk assessments and technical problem-solving
• Introduce new technologies, materials and manufacturing methodologies
• Translate customer and market requirements into technically viable products
• Partner with Quality and Regulatory teams on ISO 13485, FDA and EU MDR compliance
• Ensure robust design documentation, technical files and development records
• Lead cross-functional technical teams and mentor engineers
• Identify technical and project risks and drive mitigation strategiesRequirements
• Master’s degree in Biomedical Engineering, Mechanical Engineering or a related discipline
• 5+ years' experience within medical device engineering/R&D
• Strong experience in catheter development and/or catheter manufacturing
• Proven experience taking medical devices from concept through development and commercialization
• Strong knowledge of ISO 13485, FDA requirements and EU MDR
• Experience leading complex, cross-functional R&D projects
• Strong understanding of design controls, risk management, verification and validation
• Demonstrated experience mentoring and leading technical teams