Clinical Development Engineer - Advanced Energy

Intuitive•Sunnyvale, CA

About The Position

The Clinical Development Engineer (CDE) applies in-depth knowledge of the surgical environment and medical technology to work with engineers, clinicians, and internal and external stakeholders to define, develop, and validate the clinical function of new products for Intuitive’s multi-port and single-port surgical robotic platforms. The role focuses on establishing and validating data-driven clinical requirements to support high-quality patient outcomes. The CDE contributes to concept design by assessing and communicating clinical risks, providing design guidance, inventing new concepts, and executing clinical strategy. The CDE serves as a clinical expert on Intuitive products and their use, contributes to product development and clinical performance assessment, and supports new technologies through clinical studies, pre-clinical testing, regulatory documentation, and evaluation at customer sites. The position may require domestic and international travel up to 50% of the time.

Requirements

At least 5 years of medical device industry experience with a bachelor’s degree; 3 years with a master’s degree; or a Ph.D. with no experience requirement.
At least a Bachelor of Science degree in Mechanical Engineering, Biomedical Engineering, or a similar field.
Excellent mechanical aptitude and spatial-relation intuition, including the ability to understand complex mechanical products.
Interest in hands-on, lab-based work, including ex-vivo, in-vivo, and in-vitro models.
Excellent analytical capability and practical skills to develop test methods and draw conclusions.

Nice To Haves

An advanced degree.
Excellent teamwork skills and a demonstrated ability to foster collaboration across disciplines.
Effective verbal, written, and presentation communication skills.
Demonstrated success recognizing critical issues and driving them to resolution through coordinated action.
Ability to work independently with minimal supervision.
Composure and ability to react quickly under pressure.
Experience working with surgeons in an operating room environment.
Experience providing on-site clinical trial support.
Fluency in surgical terminology and sound knowledge of anatomy and surgical technique.

Responsibilities

Apply in-depth knowledge of the operating room environment and da Vinci Surgical Systems to become an expert on the clinical application of Intuitive’s products.
Provide a clinical perspective in product development by defining and assessing the clinical performance of new products.
Collaborate with marketing partners and clinicians to identify and understand clinical needs.
Use analytical approaches to identify potential product enhancements and new product ideas.
Participate in new product development teams, contribute to design reviews, and provide design guidance to engineering teams.
Assess and document clinical risks and identify appropriate mitigations.
Execute clinical studies to support technology development for regulatory 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 manuals and training documentation.
Support clinical evaluation of new products at key customer sites.
Maintain current knowledge of clinical applications of Intuitive’s products.
Keep Intuitive’s vision and values at the forefront of decision-making.
Perform other duties as required to support company strategy and goals.