Staff Catheter Engineer

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

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Job summary

Stryker in Waltham, MA is seeking a Staff Catheter Engineer to contribute across the full product development lifecycle, from concept generation and prototype development through verification, validation, and manufacturing transfer.

This hands-on role requires collaboration across functions to deliver safe, effective, manufacturable disposable balloon catheter systems, meeting clinical, regulatory, and manufacturability requirements.

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.

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.
• Support risk management, design reviews, supplier qualification activities, manufacturing transfer, and regulatory submissions through technical documentation and engineering analysis.

Education

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

Tools

SolidWorks

Job description

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.

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

• 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

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.