Clinical Development Engineer

Intuitive Surgical•Sunnyvale, CA

44d

About The Position

The Clinical Development Engineer (CDE) 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.

Requirements

Minimum of 5 years of experience in medical device industry with a Bachelor's degree, 3 years experience with a Master's degree, or a PhD degree without experience
Experience working with surgeons in an operating room environment
Fluent in surgical terminology and sound knowledge of anatomy and surgical technique
Excellent mechanical aptitude and intuition for spatial relations, including the ability to understand complex mechanical products
Excellent analytical capability and practical skills to develop test methods and draw conclusions
Excellent teamwork skills with proven ability to cultivate collaboration across multiple disciplines
Effective communication skills (verbal, written, presentation)
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
Minimum of Bachelor of Science degree in Mechanical Engineering, Biomedical Engineering, or similar; advanced degree preferred
Ability to travel up to 25% of the time, internationally and domestic
For positions related to development of the optical/vision system, the ability to have near and far visual acuity (clarity between 12 inches and 20 feet with or without corrective lenses), stereoscopy, and the ability to see all colors is required.

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