Senior Clinical Development Engineer, Digital
On-siteSunnyvale, California, United States
Job Summary
Translate surgeon needs and clinical workflow insights into requirements, risk assessments, validation strategies, and product recommendations for Intuitive's digital, automated, and software-enabled robotic surgery products. Apply in-depth knowledge of the operating room environment and da Vinci Surgical Systems to represent surgeon needs, workflow fit, usability, and patient impact. Identify unmet clinical needs through surgeon engagement, OR observation, workflow analysis, and cross-functional collaboration. Partner with engineering, software, systems, data science, human factors, product, regulatory, and quality teams to define requirements, risks, mitigations, and validation strategies. Plan, execute, and document prototype, simulated-use, preclinical, workflow-based, and clinical performance evaluations. Analyze qualitative and quantitative data to develop clinical rationale and recommendations that guide product decisions and milestone readiness. Support design-control, risk management, regulatory, labeling, training, and customer-facing documentation as needed. Lead complex clinical development workstreams, mentor others, and influence cross-functional product direction. Maintain expertise in robotic surgery, digital surgery, automated surgical tasks, AI/ML-enabled technology, clinical applications, and emerging standards. Travel up to 25% of the time, internationally and domestically, including travel to customer sites, labs, preclinical facilities, conferences, and clinical evaluation locations.
Required Qualifications
- Minimum of 8 years of experience in medical device industry with a Bachelor's degree, 6 years experience with a Master's degree, or 3 years with a PhD degree
- Proven experience in supporting a medical product from design to launch
- Experience in regulated medical device product discovery and/or new product development
- Experience working with surgeons or clinical experts in OR, simulation, lab, or clinical evaluation settings
- Strong knowledge of surgical terminology, anatomy, technique, and minimally invasive or robotic surgical workflows
- Ability to translate clinical needs into user needs, use cases, requirements, clinical performance criteria, and validation plans
- Ability to work in operating room, simulation, lab, and preclinical environments as required
- Apply in-depth knowledge of the operating room environment and of the da Vinci Surgical Systems to become an expert within the company on the clinical application of Intuitive's products
- Serve as the clinical voice for digital, automated, and robotic surgery products, representing surgeon needs, workflow fit, usability, clinical performance, and patient impact
- Identify unmet clinical needs through surgeon engagement, OR observation, workflow analysis, competitive assessment, and cross-functional collaboration
- Partner with engineering, software, systems, data science, human factors, product, regulatory, and quality teams to define requirements, risks, mitigations, and validation strategies
- Plan, execute, and document prototype, simulated-use, preclinical, workflow-based, and clinical performance evaluations
- Analyze qualitative and quantitative data to develop clinical rationale and recommendations that guide product decisions and milestone readiness
- Support design-control, risk management, regulatory, labeling, training, and customer-facing documentation as needed
- Maintain expertise in robotic surgery, digital surgery, automated surgical tasks, AI/ML-enabled technology, clinical applications, and emerging standards
- Lead complex clinical development workstreams, mentor others, and influence cross-functional product direction
- Keep Intuitive's vision and values at the forefront of decision making
- Ability to travel up to 25% of the time, internationally and domestically, including travel to customer sites, labs, preclinical facilities, conferences, and clinical evaluation locations
- Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19
Desired Qualifications
- Experience with digital surgery, robotic automation, AI/ML-enabled tools, computer vision, navigation, image guidance, or software as a medical device
- Familiarity with design controls, ISO 14971, usability engineering, human factors, clinical validation, and evidence strategies
- Experience with digital interfaces, workflow-integrated software, data-driven product development, annotation workflows, model evaluation, or clinical data review
- Strong systems thinking, analytical skills, data interpretation, test method development, and evidence-based decision-making
- Excellent communication, collaboration, prioritization, escalation, and cross-functional leadership skills in ambiguous technical and clinical environments
- Proven success recognizing critical issues and driving them to closure by taking coordinated action
- Self-starter needing minimal supervision
- Self-confident and able to react quickly under pressure
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.