Staff R&D Engineer (Catheter & Mechanical Systems) - NuevoSono
About The Position
NuevoSono, a T45 Labs portfolio company, is developing a next-generation intravascular ultrasound (IVUS) platform designed to simplify workflows, improve image quality, and deliver clinically meaningful insights at the point of care. We operate in a fast-paced start-up environment where engineers take ownership and move quickly from concept to working hardware. 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. You will take responsibility for larger portions of development and operate with a high degree of independence while working closely with technical leadership.
Requirements
- 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
- Experience building, troubleshooting, and iterating on physical hardware
- Comfortable working in a fast-paced, start-up environment with evolving priorities
- Familiarity with FDA 21 CFR Part 820, ISO 13485, and ISO 14971
- Expert proficiency in Solidworks
- Candidates must be permanently authorized to work in the United States without the need for current or future visa sponsorship.
Nice To Haves
- A highly independent engineer who still builds and tests
- Someone who can take ownership of complex work and run with it
- Strong balance of technical judgment and hands-on execution
- Comfortable partnering closely with technical leadership in a fast-paced start-up environment
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
