Senior R&D Engineer Catheters (m/f/d)
Core
Technical lead for developing catheters and interventional devices from concept to manufacturing transfer, ensuring design-to-manufacture and regulatory compliance.
Role type
Senior R&D Engineer (Medical Devices)
Builds
Catheters, access devices, and complex delivery systems for medical use
Domain
Medical device manufacturing / Interventional devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Catheter design and materials, Design-to-manufacture (DfM), Design control and regulatory standards (ISO 13485, FDA 21 CFR Part 820), Risk management (FMEA), Design verification and simulated use testing, Statistical tools (DOE, tolerance stack-up, Minitab), Prototyping, Cross-functional team leadership
Preferred skills
Master's degree in biomedical/mechanical/plastics engineering, Patents or publications in catheter development, Experience with extrusion/thermoforming/laser processing
Technologies
PLM systems, Minitab, DOE tools
Responsibilities
Lead development projects from concept freeze to manufacturing transfer, Develop and build prototypes, Develop test methods for bench testing and validation, Ensure engineering documentation under design control, Mentor less experienced team members, Guide project structuring and team formation
Seniority
Senior, hands-on IC with mentorship