Clinical Development Engineer – Vision

At Intuitive, we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. Our mission is our guiding force; our culture is the DNA that makes us unique.  

As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare’s complex challenges. 

We believe a great idea can come from anywhere—inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and strive to achieve their highest potential.  

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s help to advance the world of minimally invasive care. 

“Championing clinical needs to shape innovation for world class patient care”

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 imaging 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. This role focuses on the imaging and visualization (vision) systems of the surgical robotic platforms.

Roles and Responsibilities:

This position has responsibility and authority for the following:

New Product Development: Vision:

  • 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 in the imaging space
  • Collaborating with research teams to help with quick design iteration and assessment of imaging 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: design engineering, 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
  • Clinical Risk Analysis
  • Clinical Design Validation/Chronic Animal Study/Histopathology Protocols & Reports
  • Early Feasibility Study / 510K / regulatory submission content
  • User manual and training documentation

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

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 relevant 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 understanding of imaging hardware or software, including the ability to understand complex imaging systems
  • 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)
  • Flexibility to adapt to fast-paced environment to meet business needs
  • 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 20% of the time, internationally and domestic

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.  

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. 

Shift : Shift 1 - Day

Travel : Yes, 25 % of the Time

Travel Requirements: Yes, 25 % of the Time Shift: Shift 1 - Day
Company
Intuitive
Posted
06/01/2021
Type
Full time
Location
Sunnyvale, CA, US