Sr. Clinical Development Engineer, Endoluminal

Intuitive Surgical•Santa Clara, CA

43d

About The Position

This Sr. Clinical Development Engineer, Endoluminal (CDE) position reports to the Sr. Manager of Clinical Development Engineering on the Ion Endoluminal platform. In this position, a Sr. CDE utilizes their in-depth clinical, technical and design control knowledge to collaborate with physicians and design engineering to discover, define, develop, and validate new product solutions for flexible robotic catheter platforms. Their primary focus is to understand user needs, establish clinical and engineering requirements, consider clinical risks and identify solutions to guide product development. They also help explore robotic clinical applications for Intuitive products, as well as future opportunities to optimize product integration into the clinical setting.

Requirements

B.S. in Mechanical Engineering, Biomedical Engineering or similar, advanced degree preferred
Minimum of 6 years of relevant experience in medical device industry required
Ability to understand complex robotic products
Experience collaborating with physicians and collecting feedback on clinical use of the product
Experience working in cross-functional teams and proven ability to cultivate collaboration across multiple disciplines (marketing, regulatory, quality, product design, engineering, human factors) to insure project success
Experienced in driving complex medical devices from concept to market
Experience developing design validation strategy, protocol creation and testing
Experience leading hands-on product evaluation testing in a pre-clinical lab setting
Fluent in medical terminology and sound knowledge of anatomy
Self-starter needing minimal supervision
Self-confident and able to react quickly under pressure
Excellent verbal and written communications skills required including presentation of technical content
Ability to travel up to 25% of the time, internationally and domestic

Responsibilities

Apply in-depth knowledge of the clinical procedure and of medical technology in order to become an expert within the company on Intuitive's products and clinical applications
Collaborate with physicians and key clinical users to understand the clinical need
Provide a clinical voice for design and evaluation of Intuitive's products
Assess potential clinical risks and mitigations to drive appropriate product design
In-depth technical understanding of the Intuitive products and adjunct medical device technology that includes mechanical, software, algorithms, electronics aspects of the device
Drive product discovery in collaboration with product management and product design teams by being the internal champion of clinical need
Lead early design investigation teams that are lean and efficient for product enhancements & new product ideas
Lead post market investigation by conducting clinical risk assessment, clinical workflow investigation and pre-clinical testing for critical field issues.
Drive stakeholder alignment frequently and solicit appropriate user feedback.
Drive decision making and escalate key issues quickly
Keep the organization's vision and values at the forefront of decision making and action.
Drive early design decisions with sound understanding of design control, clinical risks and evaluation strategy
Drive design validation testing strategy for new products and get alignment on the strategy with key regulatory and engineering stakeholders
Support product launches and collect early field feedback in collaboration with product management
Closely collaborate with other organizations within the company, including design, marketing, regulatory, human factors, training, product management, and sales throughout product development and testing