Staff Catheter Engineer

Staff Catheter Engineer

Waltham, MA

Join a team focused on the design, development, and commercialization of innovative disposable catheter technologies in the intravascular lithotripsy market. As a Staff Catheter Engineer, you will contribute across the full product development lifecycle, from concept generation and prototype development through verification, validation, and manufacturing transfer. This role combines hands-on engineering, technical problem-solving, and cross-functional collaboration to support the delivery of safe, effective, and manufacturable medical devices.

• Design and develop disposable balloon catheter systems and catheter platforms for new and existing applications.
• Create catheter concepts that meet clinical, functional, manufacturability, and regulatory requirements.
• Develop engineering drawings, specifications, and design documentation using Solid Works and established documentation practices.
• Select and evaluate catheter materials, including polymers, balloons, shafts, braids, coils, adhesives, and marker bands.
• Develop and optimize catheter manufacturing and assembly processes, including balloon bonding, thermal forming, lamination, tip forming, adhesive bonding, and laser processing.
• Plan, execute, and document verification and validation testing to confirm compliance with design requirements, applicable standards, and regulatory expectations.
• Investigate design and process issues, perform root cause analysis, and implement corrective actions to improve product performance, manufacturability, and reliability.
• Support risk management, design reviews, supplier qualification activities, manufacturing transfer, and regulatory submissions through technical documentation and engineering analysis.

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or a related engineering discipline.
• Minimum 4 years of experience in medical device product development.
• Experience designing catheter systems, including prototype development, assembly, or testing activities.
• Proficiency with Solid Works.
• Experience applying Design Controls within FDA and ISO requirements.

• Experience with balloon catheter technologies, balloon forming, or catheter manufacturing processes.
• Experience with extrusion, braiding, coiling, laser processing, or related catheter manufacturing methods.
• Experience working in ISO Class 7 or ISO Class 8 cleanroom environments.
• Training or experience in statistical analysis, Design of Experiments (DOE), Design Failure Mode and Effects Analysis (DFMEA), or Process Failure Mode and Effects Analysis (PFMEA).

• $107,200 - $178,600 USD Annual