Sr. Clinical Development Engineer

Sr. Clinical Development EngineerMoon Surgical Jobs BoardDesired start date: March 1, 2025Location: San Carlos, CaliforniaMoon Team Photos 2.jpg

The Role:Your Core ResponsibilitiesAs 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 ActivitiesIn 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.
• Mentor junior engineers and support their professional development while fostering a culture of innovation and collaboration.How You'll Fit InThis role reports to the Clinical Development Engineering Manager and partners closely with Product, Marketing, and Quality leadership. You will be a key driver of cross-functional collaboration and external engagement, ensuring that products exceed user expectations and adapt seamlessly to the clinical environment. Your expertise will influence strategic decisions and product roadmaps while ensuring robust alignment with clinical requirements.

Qualifications, Skills & Attributes: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.

Compensation, Benefits & Other Details:Sound like a fit We would be excited to hear from you! APPLY HERE.pngThis role Sr. Clinical Development Engineer will be a core team member of a small, , cross-functional For example, supporting clinical trial activities, visiting hospitals, supporting and engaging in all elements of product development - from ideation to commercial support. This helps to ensure candidates understand the unique requirements of Moon Surgical and are both comfortable and qualified.

• English fluency
• Education: BS in biomedical engineering, mechanical engineering, or equivalent
• Experience: Internship or research experience involving animal study, first-in-human, or other clinical support experience in medical devices
• Clinical knowledge: Strong understanding of clinical research principles, regulations, guidelines. Experience in the field of surgery and/or minimally invasive surgery a plus.
• Travel: A minimum of 1 week of travel per month for the first 6 months
• Communication skills: Excellent technical writing and presenting skills
• Technical skills: Understands the medical device development process, engineering principles of materials and mechanical design
• Regulatory knowledge: Strong understanding of regulatory pathways for medical devices in the US and EU to ensure that clinical and usability activities comply with regulations
• Credentialing: Previous credentialing with US hospital systems for shadowing, proctoring, other clinical support preferredJob Description Template /Add a New Job DescriptionJob Descriptions
• 25 Days of Paid Vacation
• 10 Paid Holidays
• 401k with matching
• Competitive Vision, Dental, and Health benefits
• Regular national and international travel required