Clinical Development Engineer

Intuitive•Sunnyvale, CA

30d

About The Position

Primary Function of Position: The Post Market Clinical Development Engineer uses their in-depth knowledge of the surgical environment and medical technology to investigate, understand, and address opportunities with products in the field work. The Post Market CDE also works with failure analysis/design engineers and clinicians to define, develop, and validate the clinical function of product improvements within our surgical robotic system platforms. They investigate and refine products including robotic systems, visualization platforms, instruments and accessories that ultimately improve the clinical outcome for patients. 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 B.S. in Mechanical Engineering, Biomedical Engineering, or similar, advanced degree preferred
Minimum of 5 years of experience in medical device industry with a B.S, 3 years experience with an M.S, or a PhD without experience
Experience working in Risk Management specifically in ISO 14971
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
Ability to travel up to 25% of the time, internationally and domestic

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
Work with regulatory surveillance, failure analysis engineering, clinical sales representatives, and surgeons, acting as a ‘detective’ to assess how use scenarios contribute to findings and address root cause
Partner with Medical Safety Officer to characterize potential health hazards and feed evaluations to field action decision team
Provide a clinical voice to product development by defining and assessing clinical performance of legacy products
Collaborate closely with product engineering to define and assess products against clinical performance goals for product improvements
Use an analytical approach to identify potential product enhancements
Take an active role in sustaining engineering 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
Write protocols and conduct formal validation testing for product updates and releases, and modifications to existing designs, in order to validate the clinical safety and efficacy of the product. Support FDA/regulatory documentation and applications
Provide subject matter expertise to user manual and training documentation development
Maintain current knowledge of clinical applications of Intuitive’s products
Collaborate with other organizations within the company as needed, including new product development, regulatory, quality, marketing, human factors, training, and sales
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