Sr. Clinical Development Engineer

A Sr. Clinical Development Engineer at Intuitive Surgical leads clinical and technical work on the Ion Endoluminal platform. The role reports to the Clinical Development Engineering Manager and leverages deep clinical, technical, and design control knowledge to collaborate with physicians and design engineering teams to discover, define, develop, and validate new product solutions for flexible robotic catheter platforms. The primary focus is to understand user needs, establish clinical and engineering requirements, evaluate clinical risks, and identify solutions to guide product development. The position also explores future robotic clinical applications and solutions.

Responsibilities

• Apply in-depth clinical knowledge and technical system understanding to define and develop products based on clinical needs
• Collaborate with physicians and key clinical users on clinical procedure development and gather product feedback
• Clearly define clinical needs and translate them into product requirements
• Develop test models and test methods for clinically relevant product evaluations
• Assess potential clinical risks and propose mitigations to inform product design
• Observe cases and communicate assessments of robotic value and opportunities
• Contribute clinical expertise to protocol design and strategy
• Participate in early design investigation teams focused on product enhancements and new product ideas
• Drive stakeholder alignment, solicit user feedback, and support decision making; escalate key issues promptly
• Educate cross-functional teams on clinical workflow
• Support product launches and clinical trials, collecting early field feedback
• Conduct clinical risk analyses for new products or updates
• Lead testing and clinical evaluations of new product features
• Collaborate with regulatory, human factors, training, engineering, and product management to determine design and development inputs
• Drive design validation testing strategy for new products and align the strategy with key regulatory and engineering stakeholders

Requirements

• Masters or PhD in Mechanical Engineering, Controls Engineering, Biomedical Engineering, or a related field

• Minimum of 4 years of clinical development and design control experience, including an MS

• Experience driving medical device products and features from concept to market

• Experience collaborating with physicians and collecting feedback on clinical use of products

• Experience understanding clinical harms and performing clinical risk analysis

• Fluent in medical terminology with solid knowledge of anatomy

• Nice to have

• Experience working in cross-functional teams and the ability to cultivate collaboration across disciplines (marketing, regulatory, quality, product design, engineering, human factors)

• Experience developing design validation strategies, protocols, and testing

• Experience leading hands-on product evaluation testing in a pre-clinical lab setting

• Self-starter with minimal supervision

• Confident under pressure with the ability to adapt priorities in a fast-paced product development environment

• Excellent verbal and written communications skills, including presenting technical content