Intuitive Surgical Careers

Clinical Development Engineer

Sunnyvale, California
Engineering


Job Description

Job: Engineering
Primary Location: United States-California-Santa Clara County-Sunnyvale
Schedule: Full-time

Description

Company Description:

Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.


Primary Function of Position:


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
Design History
  • 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)
Other
  • 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
Qualifications

Skill/Job Requirements:

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


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