Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 193965
Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position:
The Senior Clinical Development Engineer (CDE) uses their in-depth knowledge of medical technologies to work with design engineers and clinicians to define, develop, and validate the clinical function of new products within robotic platforms. They help develop or refine products including robotic systems, visualization platforms, instruments and accessories that ultimately improve the clinical outcome for patients. Their primary focus is to establish clinical requirements and risks and validate that the products address them. They also help integrate Intuitive’s products into robotic clinical applications, as well as monitor the clinical needs and opportunities in the market.
Roles and Responsibilities:
This position has responsibility and authority for the following:
New Product Development:
• Apply in-depth knowledge of the operating room environment and of medical technology in order to become an expert within the company on the clinical application of Intuitive’s products• Work with physicians to identify clinical needs and complementary devices in the marketplace• Identify potential product enhancements & new product ideas by applying an analytical approach to understanding the clinical needs• Collaborate closely with product management and product development to define and validate clinical performance goals for new products• Assess and document clinical risks, and advise engineering regarding risks and mitigations• Take an active role in new product development teams, including contributing to team meetings and design reviews, and providing design guidance to engineering design teams• Conduct assessments of the clinical performance of prototype designs, working with the internal cross-functional team and with external key opinion leaders• Write protocols and conduct formal validation testing for new products, 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• Work with product management and product marketing to conduct product-specific “focus group” meetings with key customers at scientific conferences and in house• Support and sometimes manage clinical evaluation of new or enhanced products at key customer sites• Maintain up-to-date knowledge of clinical applications of Intuitive’s products and to transfer product knowledge to that group as part of product and procedure launch activities• Provide a clinical voice and evaluation to continuing engineering projects of Intuitive’s products• Collaborate with other organizations within the company as needed, including regulatory, human factors, training, and sales• Keep the organization’s vision and values at the forefront of decision making and action• Perform other duties as required to support the company's overall strategy and goals
Qualifications• Product Requirement Documents (owning clinical requirements)• Clinical Risk Analysis (owner)• Clinical Design Validation Protocols & Reports (owner)• 510K/regulatory submission content (subject matter expert)• User manual and training documentation (subject matter expert)
To adequately perform the responsibilities of this position the individual must have:
We are an AA/EEO/Veterans/Disabled employer.• Minimum of B.S. in Mechanical Engineering, Biomedical Engineering or similar• Minimum of 5 years of experience in medical device industry required• 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 and test a thesis and draw succinct conclusions• Excellent teamwork skills with proven ability to cultivate collaboration across multiple disciplines to ensure timely project success• 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• Excellent verbal and written communications skills required including presentation of technical content• Ability to travel up to 25% of the time, internationally and domestic
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.