Sr Catheter Engineer

Key Responsibilities

• Drive the full lifecycle of medical device development, from innovative concept generation and prototyping to final process development and design transfer.
• Serve as the Subject Matter Expert for guidewire and catheter interventional processes, providing technical guidance on complex design challenges.
• Develop creative design concepts using 3D modeling (SolidWorks), drafting, and rapid prototyping to meet specific client needs.
• Design, optimize, and document manufacturing and assembly processes. Execute Design of Experiments (DOE), verification, validation, and process characterization.
• Build prototypes and perform bench testing to evaluate device performance and "manufacturability."
• Maintain high-quality engineering documentation, including DHF records, specifications, and verification protocols in compliance with FDA and ISO 13485 standards.
• Work closely with external clients to translate their vision into a functional, finished product, managing project records and time-and-materials efforts.
• Seamlessly transfer designs and processes from the R&D stage into full manufacturing environments.

Required Qualifications

• Experience: 5+ years (Senior level) of hands-on experience in catheter, guidewire, or minimally invasive medical device development.
• SME Expertise: Proven track record as a Subject Matter Expert in interventional processes and guidewire/catheter fabrication.
• Education: Bachelor’s or Master’s degree in Biomedical, Mechanical, Manufacturing, or Polymer Engineering.
• Technical Skills: Deep knowledge of fabrication techniques: catheter assembly, reflow, UV/solvent bonding, extrusion, tipping, grinding, and small-component assembly.
• Design-to-Manufacturing Mindset: Experience in a design-manufacturing environment where the goal is delivering a finished concept or product to a customer.
• Software: Proficiency with 3D CAD (SolidWorks).
• Regulatory: Working knowledge of FDA regulations, Design Control processes, and GMP.

Preferred Skills

• Materials Science: Experience with Pebax, Nylon, PTFE, FEP, PEEK, Nitinol, and Stainless Steel.
• Client Management: Experience in a "Design Services" or consulting-style engineering role.
• Mentorship: Ability to lead junior engineers and drive technical excellence across the team.
• Precision: Strong problem-solving skills with high attention to detail in a regulated environment.