Desired start date: March 1, 2025

Location: San Carlos, California

We believe the future of the operating room lies in the hands of the empowered surgeon. They are bolstered with complete control, renewed confidence, and technology adaptable to any situation.

Our Maestro System delivers this empowerment, resulting in improved operating room efficiency and surgical care for patients - We are using tomorrow's technology to change surgery today.

Our blended French-American team is passionate about building this future. Together we are pushing the boundaries in a fast-paced yet focused and deliberate environment. We challenge ourselves often and celebrate our achievements. We believe that communication and planning are as important as execution.

🎉 The Role

Your Core Responsibilities

As a Senior Clinical Development Engineer, you will play a pivotal role in bridging the technical and clinical aspects of the development of the Maestro System, a robotic first assistant for laparoscopy. You will lead validation studies with end users, manage benchtop and cadaver labs to test early-stage designs, and ensure that clinical insights from the field directly influence product design and development.

• Direct and oversee clinical research and ensure the seamless integration of the Maestro System into clinical practice.
• Design and manage pragmatic usability studies, including the creation of study protocols, user recruitment, and report writing.
• Plan, oversee, and analyze data from internal cadaver labs and other research sources, to drive efficient decisions and achieve corporate goals.
• Lead the development of a use-related risk analyses based on clinical user interviews and usability studies, while ensuring regulatory compliance and appropriate risk mitigation.

Your Day-to-day Activities

In this highly cross-functional and leadership-driven role, you will collaborate extensively with product management, marketing, software, hardware, and quality teams to address users’ clinical needs and mitigate use risks. Your responsibilities will include:

• Lead clinical commercial launch activities, including on-site support
• Oversee the planning and execution of internal evaluations and wet labs to stress test prototypes, support regulatory activities, or facilitate sales processes.
• Establish and maintain strong relationships with surgeons, nurses, technicians, and other clinical stakeholders.
• Guide and execute on-system testing and development for software and hardware features, leveraging clinical insights to inform innovation.
• Provide strategic direction for accessory (drape, coupler) and system development, including creating labeling designs and detailed part drawings in tools like Adobe Illustrator, Microsoft Office, and SolidWorks.
• Lead the documentation of protocols, reports, and risk assessments, ensuring compliance and quality using tools like Jama and Enzyme.