Staff CDE

Intuitive Surgical-posted 3 months ago

Full-time • Senior

Sunnyvale, CA

5,001-10,000 employees

Miscellaneous Manufacturing

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This Staff Clinical Development Engineer (CDE) position reports to the Clinical Development Engineering Director on the Ion Endoluminal platform. In this position, a Staff 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.

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
Establish milestones and success criteria for early investigations
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
Create Best Practices guidelines, white papers and mentor junior members of the team through product discovery and development
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

Masters in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or similar
Minimum of 15 years of experience in medical device industry required
Minimum of 10 years of clinical development and design control experience
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
Willingness to mentor more junior team members
Excellent verbal and written communications skills required including presentation of technical content
Ability to travel up to 25% of the time, internationally and domestic

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