Staff Engineer, Catheter Systems

Duties And Responsibilities

• Lead all phases of catheter system development: concept generation, prototyping, design iteration, design freeze, verification, and validation.
• Translate clinical and user needs into design requirements and specifications, and develop and maintain associated design documentation.
• Design and develop jigs, fixtures, and tooling to support R&D and small-scale manufacturing activities.
• Conduct hands-on bench and mechanical testing of catheter prototypes in anatomical models; interpret results and drive design improvements.
• Manage design timelines, track milestones and deliverables, and proactively identify and mitigate risks on the critical path.
• Establish and maintain efficient engineering development processes with accurate and comprehensive documentation.
• Manage partnerships with external contract design and manufacturing organizations.
• Develop a deep understanding of how the catheter delivery system interfaces and integrates with the evFiber neuromodulation lead, and design for seamless integration.
• Collaborate across engineering, science, and clinical teams to ensure system-level requirements are met and project milestones are achieved on schedule.
• Support design and development activities involving electrical connectors and electrolytic detachment mechanisms as needed.
• Identify and evaluate catheter component suppliers and contract manufacturers; leverage a solid understanding of the catheter manufacturing landscape to inform design-for-manufacturing decisions.

Qualifications

• Required Qualifications:
• Degree in Mechanical Engineering or a related engineering discipline.
• 7+ years of hands-on industry experience in catheter R&D, with experience in neurovascular device development.
• Demonstrated experience developing a novel catheter or endovascular device from scratch — including early-stage prototyping, iterative design, and design refinement.
• Strong working knowledge of catheter manufacturing processes and design-for-manufacturing principles; solid familiarity with the catheter component vendor landscape.
• Proficiency in SolidWorks and 3D CAD; ability to create detailed engineering drawings and models.
• Experience with 3D printing and rapid prototyping technologies (FDM/SLA), including design and fabrication of jigs and fixtures.
• Experience developing catheter systems with delivery or actuation mechanisms — such as stent delivery, embolic coil delivery, or similar.
• Ability to translate user needs into design requirements and perform basic risk assessment (failure modes and risk levels) for catheter devices.
• Strong organizational skills and attention to detail.
• Experience working in a startup environment; comfortable wearing multiple hats, challenging yourself, and stepping up as needed.
• Preferred Qualifications:
• Experience working on Class III implantable medical devices.
• Exposure to electrical systems adjacent to catheter development — such as electrolytic embolic coil detachment systems or active implantable medical devices.
• Experience with vascular access devices and technical knowledge of interventional and endovascular therapies.
• Experience managing contract manufacturers, suppliers, and external development partners.
• Experience with the full product development lifecycle from ideation through commercialization.