Research And Development Engineer

Seeking a hands-on R&D Engineer to support the development of catheter-based medical devices from early concept through manufacturing transfer and commercialization. This role is heavily focused on catheter design, prototyping, process development, and technical problem solving in a fast-paced product development environment. The ideal candidate brings deep, practical experience working with catheter systems and thrives in a build-test-iterate setting rather than purely CAD-driven design work.

Responsibilities

• Lead and execute catheter product development activities from concept through design transfer and commercialization


• Build, assemble, and evaluate catheter prototypes to assess feasibility, performance, and manufacturability


• Develop and optimize catheter fabrication processes (e.g., extrusion, reflow, bonding, tipping, braiding integration)


• Translate clinical and user needs into product requirements, test methods, and development plans


• Design and implement test methods, fixtures, and characterization studies to support verification and validation


• Partner cross-functionally with Manufacturing, Quality, Regulatory, and suppliers to ensure smooth scale-up and transfer


• Troubleshoot technical and process issues using hands-on root cause analysis and data-driven approaches


• Generate technical documentation to support V&V, risk management, and design transfer activities


• Interface with physicians and key stakeholders to inform product development decisions


• Support continuous improvement of catheter designs and manufacturing processes

Qualifications

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, or related)


• 2-5+ years of hands-on catheter development experience required


• Demonstrated experience supporting products from early R&D through manufacturing transfer


• Strong practical knowledge of catheter materials and processes (e.g., extrusion, lamination, bonding, reflow, tipping)


• Proven ability to build and test prototypes in a lab environment


• Experience developing test methods and working within medical device design controls


• Working familiarity with SolidWorks and standard lab equipment


• Strong problem-solving mindset with the ability to work cross-functionally in a fast-paced environment


• Excellent communication and documentation skills

Nice to Have

• Experience with Class II or Class III catheter-based devices


• Background in process development or manufacturing scale-up


• Experience working directly with physicians or in clinical settings


• Knowledge of statistical analysis and DOE