Senior Catheter Engineer — Design, Testing & Manufacturing

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

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