The Clinical Development Engineer uses their in-depth knowledge of the surgical environment and medical technology to work with design engineers and clinicians to define, develop, and validate the clinical function of new products within our multi-port and single-port surgical robotic platforms. The primary focus of the CDE is to establish and validate data-driven clinical requirements to ensure a high-quality patient outcome.
Roles & Responsibilities:
- 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
- Provide a clinical voice to product development by defining and assessing clinical performance of new products
- Collaborate with marketing partners and clinicians to identify and understand clinical needs
- Use an analytical approach to identify potential product enhancements and new product ideas
- Take an active role in new product development teams, including contributing to design reviews, and providing design guidance to engineering design teams
- Assess and document clinical risks, and identify appropriate mitigations
- Conduct pre-clinical testing to validate the safety and efficacy of new products
- Support regulatory documentation and submissions
- Provide subject matter expertise to user manual and training documentation development
- 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 the company’s overall strategy and goals