Staff Catheter Engineer

Stryker Group; Waltham (MA); On-site; USD 107,000 - 179,000; Full time

Job summary

Stryker Group in Waltham, MA is seeking a Staff Catheter Engineer to lead the design, development, and commercialization of disposable catheter technologies for intravascular lithotripsy. You will contribute across the full product lifecycle, from concept through validation and manufacturing transfer, working hands-on to deliver safe and manufacturable devices.

The role requires a mechanical/biomedical background, 4+ years in medical device development, catheter design experience, SolidWorks

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 and knowledge of design controls within FDA/ISO requirements.

Responsibilities

• 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.

Education

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or related engineering discipline

Tools

SolidWorks

Job description

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