Staff Clinical Development Engineer Surgical Applications
Intuitive

Sunnyvale, California

Posted in Manufacturing and Production
about 1 month ago


This job has expired.

Job Info


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. 

Building the bridge between clinical and technical to shape future surgical technologies

Clinical Development Engineers hold a unique position within product and procedure development at Intuitive Surgical; enabling the safe, effective, and reliable use of surgical robotic platforms and their components.

With your passion for patient care, your analytical background, and your understanding of surgical needs, you work to make the ‘art’ of surgery objective. We are looking for someone with the ability to keenly observe the surgical environment, quickly absorb relevant information, and diligently execute iterative assessments and design validations to drive procedure development. Efficient and effective communication skills are required to weave between working with the technology and those that both use and design it. 

Interdisciplinary responsibilities include:

  • Investigating potential new Da Vinci surgical procedures through market research and Key Opinion Leader interviews
  • Collaborating with cross-functional partners, including Marketing, Clinical Affairs, Regulatory Affairs, Quality, and Project Management to add additional on-label Da Vinci surgical procedures
  • Creating “clinical procedure packages” to facilitate the training and marketing of Da Vinci surgical procedures, including comprehensive procedure guides and instructional surgical videos
  • Conducting formative evaluations of products and procedures within the development pipe-line
  • Creating data-driven clinical product requirements and clinical risk analysis documents, and then performing summative validations of those risks and requirements
  • Attending case observations and facilitating first human use studies
  • Communicating across all parts of the organization: training, research, design, manufacturing, quality, marketing, sales, and regulatory

Job Description

Primary Function of Position:

The Staff Clinical Development Engineer (CDE), Surgical Applications uses their in-depth knowledge of the Da Vinci Surgical System and surgical workflows to work with clinicians and cross-functional partners to develop safe and highly effective procedures.  The Staff CDE is responsible for and validating new surgical procedures and establishing data-driven clinical requirements to ensure a high-quality patient outcome and for conveying the clinical value throughout the organization.  This Staff CDE will also create internal- and customer-facing clinical procedure materials to communicate the best practices for performing Da Vinci surgical procedures.

Roles and Responsibilities:

This position has responsibility and authority for the following:

New Procedure 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
  • Drive the strategic plan for SP procedure development, working with internal and external stakeholders
  • Collaborating closely with cross-functional partners and subject matter experts (SMEs) to define clinical performance goals and potential risks for new Da Vinci surgical procedures
  • Assessing and documenting clinical risks, and advising engineering regarding risks and mitigations
  • Working with cross-functional partners and internal and external SMEs to identify the clinical value, development needs, and potential market opportunity of new Da Vinci surgical procedures in relation to conventional minimally-invasive and open procedures
  • Evaluating new product opportunities that would enhance the procedure pipeline
  • Collaborating with the new product development APD teams to evaluate future potential products and where they might be applicable in the new procedure roadmap
  • Creation of clinical procedure materials such as procedure guides, set-up cards, and clinical videos to enable training and marketing to both internal and external customers.  Leveraging the knowledge of internal and external SMEs to ensure these materials communicate Da Vinci product and surgical procedure best practices
  • Collaborating with other organizations within the company as needed: regulatory, design engineering, human factors, training, quality, manufacturing, marketing and sales

Clinical Laboratory & Field Work

  • Conducting pre-clinical validations of procedures both internally and with external key opinion leaders
  • Conducting formal validation testing for new procedures to ensure clinical safety and efficacy
  • Supporting clinical evaluations of new procedures at key customer sites
  • Identifying potential product enhancements & new procedure or 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 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

Skill/Job Requirements:

To adequately perform the responsibilities of this position the individual must have:

  1. Minimum of B.S. in Mechanical Engineering, Biomedical Engineering or similar, advanced degree preferred
  2. Minimum of 12 years of related experience with a University degree; or 8 years of experience and a Master’s degree; or a PhD with 5 years of experience.
  3. Experience working with surgeons in an operating room environment
  4. Fluent in surgical terminology and sound knowledge of anatomy and surgical technique
  5. Excellent mechanical aptitude, and intuition for spatial relations, including the ability to understand complex mechanical products
  6. Excellent analytical capability and practical skills to develop and test a thesis and draw succinct conclusions
  7. Excellent teamwork skills with proven ability to cultivate collaboration across multiple disciplines to ensure timely project success
  8. Effective communication skills (verbal, written, presentation) and experience conveying complex ideas to others
  9. Proven success recognizing critical issues and driving them to closure by taking coordinated action
  10. Experience mentoring individuals in junior positions on teams and leading by example
  11. Self-starter needing minimal supervision
  12. Self-confident and able to react quickly under pressure
  13. Ability to travel up to 50% 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.

#911   

 

Shift : Shift 1 - Day

Travel : Yes, 50 % of the Time

Travel Requirements: Yes, 50 % of the Time Shift: Shift 1 - Day


This job has expired.

More Manufacturing and Production jobs


MAHLE Engine Components USA, Inc.
Russellville, Arkansas
Posted 8 minutes ago

MAHLE Engine Components USA, Inc.
Russellville, Arkansas
Posted 8 minutes ago

MAHLE Engine Components USA, Inc.
Russellville, Arkansas
Posted 8 minutes ago
View Manufacturing and Production jobs »

Job Alerts

Provide an email, zip code for jobs, and/or job category to subscribe to job alerts. Learn more now.