Staff R&D Engineer (Catheter & Mechanical Systems) - NuevoSono

Staff R&D Engineer (Catheter & Mechanical Systems) – NuevoSono

Status: Full-time, Exempt

Location: Onsite, Santa Clara, CA

Reports to: Vice President R&D

About the Company

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.

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. You will take responsibility for larger portions of development and operate with a high degree of independence while working closely with technical leadership.

Key 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
  
  

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
• 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

What We’re Looking For

• 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

Eligibility

Candidates must be permanently authorized to work in the United States without the need for current or future visa sponsorship. We are currently unable to sponsor employment visas, or permanent residency (PERM) applications.

Location and Compensation

This is an onsite role based in Santa Clara, CA, and is open to candidates living within a reasonable commuting distance of our office. At this time, we are not considering applicants who would need to relocate, either within or outside of California. There is no relocation package available.

T45 Labs and our portfolio companies are committed to fair and equitable pay practices and may also consider additional compensation elements such as bonuses, equity, and benefits as part of the total rewards package.

Salary ranges are based on San Francisco Bay Area market data. Actual compensation offered may vary depending on factors such as experience, skills, qualifications, and abilities relevant to the role, as well as t