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
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