Staff Catheter Engineer
Summary
Designs and develops disposable balloon catheter systems for medical devices, using SolidWorks and medical-device engineering practices.
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.
What You Will Do
- 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 SolidWorks 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.
What You Will Need
Required Qualifications
- 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 SolidWorks.
- Experience applying Design Controls within FDA and ISO requirements.
Preferred Qualifications
- 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