Senior Clinical Development Engineer - Advanced Energy

Intuitive•Sunnyvale, CA

About The Position

The Senior Clinical Development Engineer (CDE) applies in-depth knowledge of the surgical environment and medical technology to define, develop, and validate the clinical function of new products for Intuitive’s multi-port robotic platforms. The role works with engineers, clinicians, and internal and external stakeholders to establish and validate data-driven clinical requirements focused on high-quality patient outcomes. The CDE contributes actively to concept design and new product development by assessing and communicating clinical risks, providing design guidance, inventing concepts, and executing clinical strategy. The position also supports technology development through clinical studies, pre-clinical testing, regulatory documentation, and evaluation of new products at customer sites. The role requires hands-on lab work and experience working with surgeons in an operating room environment. The position may require travel up to 50% of the time, both domestically and internationally. Intuitive and/or its customers may require current proof of vaccination against certain diseases, including COVID-19. Compensation is based on the level at which the position is filled and the candidate’s qualifications; target compensation ranges are referenced in the posting but no amounts are provided.

Requirements

Bachelor of Science degree or higher in Mechanical Engineering, Biomedical Engineering, or a similar discipline.
At least 8 years of medical device industry experience with a bachelor’s degree, 6 years with a master’s degree, or 3 years with a PhD.
Proven experience supporting a medical product from design through launch.
Excellent mechanical aptitude and spatial reasoning, including the ability to understand complex mechanical products.
Experience working with surgeons in an operating room environment.
Fluent in surgical terminology, with sound knowledge of anatomy and surgical technique.
Ability to travel up to 50% of the time, domestically and internationally.

Nice To Haves

Advanced degree preferred.
Experience with on-site clinical trial support.
Excellent analytical capability and practical skills to develop test methods and draw conclusions.
Strong teamwork skills and demonstrated ability to foster collaboration across disciplines.
Effective verbal, written, and presentation communication skills.
Demonstrated ability to recognize critical issues and drive them to closure through coordinated action.
Self-starter who needs minimal supervision.
Composed and able to react quickly under pressure.
Passion for hands-on lab-based work, including ex-vivo, in-vivo, and in-vitro modes.

Responsibilities

Apply in-depth knowledge of the operating room environment and da Vinci Surgical Systems, and develop expertise in the clinical application of Intuitive products.
Define and assess the clinical performance of new products, providing a clinical perspective to product development.
Collaborate with marketing partners and clinicians to identify and understand clinical needs.
Use analytical approaches to identify product enhancements and new product ideas.
Participate in new product development teams, including design reviews, and provide design guidance to engineering teams.
Assess and document clinical risks and identify appropriate mitigations.
Execute clinical studies supporting technology development, regulatory strategies, and reimbursement strategies.
Conduct pre-clinical testing to validate the safety and efficacy of new products.
Support regulatory documentation and submissions.
Provide subject matter expertise for user manual and training documentation development.
Support clinical evaluation of new products at key customer sites.
Maintain current knowledge of clinical applications of Intuitive products.
Keep Intuitive’s vision and values at the forefront of decision-making.
Perform other duties as required to support the company’s strategy and goals.