Staff R&D Engineer - NuevoSono

About The Role

We are seeking a Staff R&D Engineer (Catheter & Mechanical Systems) to join our team and lead development of catheter systems and mechanical workstreams within the platform. This is a mechanical engineering-focused role with expanded ownership, centered on catheter development, hardware build, and iterative testing.

• Lead development of catheter systems, including shafts, hubs, and assemblies
• Own end-to-end workstreams, from concept through prototype, testing, and build
• Drive technical problem-solving and iterative development
• Support system integration and overall device performance
• Build and evaluate prototypes and system-level concepts
• Define and execute testing approaches, including verification activities
• Develop manufacturing processes for catheters, microelectronic integration, and mechanical assembly
• Maintain and guide engineering documentation and DHF quality
• Contribute to risk management activities (FMEA, hazard analysis)
• Partner with vendors and manufacturing teams on scaling and transfer to production

Qualifications

• Bachelor's or Master's degree in Mechanical Engineering or Biomedical Engineering with a strong mechanical engineering focus
• 8+ years of experience in medical device R&D
• Deep, hands-on catheter development experience, including direct involvement in catheter design, prototyping, and testing
• Strong background in mechanical and mechanism design, with hands-on experience developing and refining user-actuated systems and handheld device mechanisms
• Experience designing and developing mechanical systems, linkages, and actuation mechanisms, with a solid understanding of force transmission, tolerances, and material behavior
• Proven ability to own and drive complex work independently
• Strong system-level thinking, including integration of mechanical components within catheter-based or device systems
• Comfortable working in a fast-paced, start-up environment with evolving priorities
• Familiarity with FDA 21 CFR Part 820, ISO 13485, and ISO 14971