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.

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

• Bachelors 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).

• $107200 - $178600 USD Annual