Clinical Development Engineer - Advanced Energy

Intuitive•Sunnyvale, CA

4d•$132,000 - $223,500•Onsite

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 other stakeholders in defining, developing, and validating the clinical function of 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, developing new concepts, and executing clinical strategy. The position involves providing clinical input throughout product development, identifying clinical needs and product opportunities, guiding design teams, assessing and mitigating risk, and conducting clinical studies and pre-clinical testing. The CDE also supports regulatory documentation, user manuals and training materials, and clinical evaluation of products at customer sites. The role requires up to 50% domestic and international travel. The position is described as a day-shift, set-schedule role that will be onsite weekly, with the percentage of onsite work determined by the leader.

Requirements

At least 5 years of medical device industry experience with a bachelor’s degree, 3 years with a master’s degree, or a PhD with no experience required.
At least a Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or a similar field.
Excellent mechanical aptitude and spatial intuition, including the ability to understand complex mechanical products.
Passion for 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.
Ability to travel up to 50% of the time, domestically and internationally.

Nice To Haves

An advanced degree.
Excellent teamwork skills and a proven ability to cultivate collaboration across multiple disciplines.
Effective verbal, written, and presentation communication skills.
Proven success recognizing critical issues and driving them to closure through coordinated action.
Ability to work as a self-starter 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 a company expert on the clinical application of Intuitive products.
Provide clinical input to 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 actively 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 and 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 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 overall strategy and goals.