Clinical Development Engineer at Intuitive Surgical, Inc.
Posted in Health Care 30+ days ago.
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Location: Sunnyvale, California
Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.
“Building the bridge between clinical and technical to shape future surgical technologies”
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: Roles and Responsibilities:
The Clinical Development Engineer (CDE) uses their in-depth knowledge of the da Vinci® Surgical System to work with design engineers and clinicians to develop safe and highly effective products for our multi-port surgical robotic system platforms. The CDE is responsible for establishing and validating data-driven clinical requirements to ensure a high quality patient outcome and for conveying the clinical value throughout the organization.
Roles and Responsibilities:
This position has responsibility and authority for the following:
New Product Development:
• Applying in-depth knowledge of the operating room environment and of the da Vinci® Surgical System to become an expert on the clinical application of Intuitive’s products
• Collaborating closely with product management and product development teams to define clinical performance goals and potential risks for new products
• Collaborating with research teams to help with quick design iteration and assessment of products
• Assessing and documenting clinical risks, and advising engineering regarding risks and mitigations
• Work with clinical sales representatives, surgeons, and marketing to identify clinical needs and complementary devices in the marketplace
• Collaborate with other organizations within the company as needed: regulatory, human factors, training, quality, manufacturing, marketing and sales
Clinical Laboratory & Field Work:
• Conducting pre-clinical validations and design iteration assessments of products both internally and with external key opinion leaders
• Conducting formal validation testing for new products, product updates and modifications to existing designs, to ensure the clinical safety and efficacy of the product
• Support clinical evaluation of new or enhanced products at key customer sites
• Identify potential product enhancements & new product ideas by applying an analytical approach to understanding the clinical needs of surgeons
• Product Requirement Documents (owning clinical requirements)
• Clinical Risk Analysis (owner)
• Clinical Design Validation/Chronic Animal Study/Histopathology Protocols & Reports (owner)
• 510K/regulatory submission content (subject matter expert)
• User manual and training documentation (subject matter expert)
• Keeps the organization’s vision and values at the forefront of decision making and action
• Performs other duties as required to support the company's overall strategy and goals
To adequately perform the responsibilities of this position the individual must have:
• Minimum of B.S. in Mechanical Engineering, Biomedical Engineering or similar
• Minimum of 3 years of experience in medical device industry
• 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 insure timely project success
• 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 40% of the time, internationally and domestic
We are an AA/EEO/Veterans/Disabled employer.