Staff Catheter Engineer

Work Flexibility: Onsite

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

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.