Our retained client is actively developing world class interventional catheter based technology to dramatically improve the standard of cardiovascular patient care across the globe.

This organization continues to server as a global market leader in the interventional cardiology arena with a growing portfolio of best in class intravascular devices including catheters, sheaths, wires, dilators, left heart access devices, diagnostic hardware, as well as interventional radiology & neurology solutions.

We have been formally retained to help expand their R&D team and secure a new catheter design engineer to support multiple new next generation product innovation programs.

Take a look below and please reach out if this aligns!

Technical Skills and Experience

• Catheter design experience, including balloon, guide, delivery, or drainage catheters.
• Familiarity with medical device development and design control processes (e.g., per FDA 21 CFR Part 820 or ISO 13485).
• CAD software proficiency (e.g., SolidWorks, Creo, or AutoCAD).
• Material knowledge: Experience with thermoplastics, elastomers, and biocompatible materials like Pebax, PTFE, or polyurethanes.
• Understanding of extrusion, tipping, bonding, and thermal forming processes.
• Experience with prototyping, test method development, and root cause analysis.
• Finite Element Analysis (FEA) and/or computational fluid dynamics (CFD) skills are a plus.

Regulatory and Quality Knowledge

• Familiarity with regulatory standards: ISO 10993 (biocompatibility), ISO 10555 (catheters), and IEC 60601 (electrical safety, if applicable).
• Experience with risk analysis (FMEA, DFMEA, PFMEA).
• Understanding of design verification & validation, and working under a Design History File (DHF) framework.

Educational Requirements

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or a related field.