Interventional Design and Development Engineer

Purpose
Responsible for designing, developing, optimizing, and transferring interventional medical devices—including catheter and guidewire technologies—from concept through commercialization in a regulated environment. This role includes client-facing development, hands-on prototyping, and full lifecycle engineering support.

Essential Functions &  Responsibilities
·        Design and develop medical devices (catheters, guidewires, electromechanical systems) from concept through commercialization.

·        Generate concepts, perform modeling and prototyping, and evaluate designs against performance, regulatory, and manufacturing requirements.

·        Develop and optimize manufacturing and assembly processes including reflow, bonding, extrusion, tipping, and precision assembly.

·        Manage product development projects, including timelines, budgets, deliverables, project plans and proposals.

·        Execute design of experiments (DOE), verification, validation, and feasibility studies.

·        Conduct risk analysis including FMEA and support design reviews.

·        Develop and maintain technical documentation including DHF, drawings, BOMs, protocols, and reports.

·        Collaborate with suppliers, consultants, and cross-functional internal teams.

·        Interface with clients to communicate project status and technical solutions.

·        Support prototype fabrication, testing, troubleshooting, and continuous improvement activities.