Catheter Process Engineer

Catheter Process Engineer at CardioFocus AG in Switzerland. Focuses on developing and optimizing catheter manufacturing processes, transferring R&D designs to production, and ensuring scalability and validation.

This position is responsible for advancing the manufacturing and assembly workflows for cardiac catheters. The engineer will bridge the gap between research and production by translating R&D concepts into scalable, validated processes. Key activities include designing components, conducting experiments, and ensuring manufacturability.

Responsibilities

• Create and refine manufacturing and assembly workflows for catheters.
• Transition design and assembly procedures from the R&D department to the manufacturing floor.
• Apply design for manufacture (DFM) principles to ensure scalability.
• Plan and carry out process validation activities.
• Design and build components and sub-systems for intricate cardiac catheters.
• Conduct Design of Experiments (DOE) to optimize processes.
• Write and implement test methods, protocols, and reports.
• Perform statistical analysis on data using standard industry methods.
• Generate 3D models and technical drawings.
• Build prototypes and fixtures.
• Collaborate with vendors to source components, sub-assemblies, and services for catheter development.

Requirements

• Proven experience in developing complex endoscopic, vascular, or cardiac catheter systems.
• Deep understanding of catheter manufacturing techniques, including UV bonding, solvent bonding, reflow, extrusion, injection molding, machining, additive manufacturing, swaging, and tipping.
• Experience working with typical catheter materials such as polymers (Pebax, nylon, PTFE, FEP, PEEK) and metals (Nitinol, steel).
• Proficiency in 3D CAD modeling using SolidWorks.
• Strong written and verbal communication skills, with the ability to produce clear reports, specifications, and proposals, and effectively collaborate with cross-functional teams (R&D, MFG, Quality, Clinical, Marketing).
• Working knowledge of medical device regulatory requirements.
• Understanding of statistics for design applications and process controls, including data distribution types, tests of means, tests of variance, Ppk, and Cpk.
• Shop/fabrication skills, including familiarity with hand tools, drill press, and bandsaw. Familiarity with lathe and mill is a plus.

Nice to have

• Exposure to the development of radio frequency ablation systems or electroporation systems is a plus.
• Familiarity with lathe and mill is a plus.