Sr. Clinical Development Engineer, Endoluminal

Primary Function of Position:

This Sr. Clinical Development Engineer (CDE) position reports to the Manager of Clinical Development Engineering on the Ion Endoluminal platform. In this position, a Sr. CDE utilizes their in-depth clinical, technical and design control knowledge to collaborate with physicians and design engineering to discover, define, develop, and validate new product solutions for flexible robotic catheter platforms. Their primary focus is to understand user needs, establish clinical and engineering requirements, consider clinical risks, and identify solutions to guide product development of significant scope and complexity. They also help explore robotic clinical applications for Intuitive products, as well as future opportunities to optimize product integration into the clinical setting.

Roles and Responsibilities:

This position has responsibilities that include:

• Clinical and Technical Knowledge
  • Apply in-depth knowledge of the clinical procedure and of medical technology to become an expert within the company on Intuitive’s products and clinical applications
  • Collaborate with physicians and key clinical users to understand clinical needs
  • Provide a clinical voice for design and evaluation of Intuitive’s products
  • Develop test models and test methods for clinically relevant product evaluations
  • Assess potential clinical risks and mitigations to drive appropriate product design
  • Apply in-depth technical understanding of the Intuitive products and adjunct medical device technology that includes mechanical, software, algorithms, and electronics aspects of the device
• Product leadership
  • Drive product discovery in collaboration with product management and product design teams by being the internal champion of clinical need
  • Lead early design investigation teams that are lean and efficient for product enhancements & new product ideas
  • Create best practices guidelines and white papers, and educate cross functional teams on clinical workflow
  • Support clinical study and/or product launch through training and case support
  • Lead post market investigation by conducting clinical risk assessment, clinical workflow investigation and pre-clinical testing for critical field issues
  • Drive stakeholder alignment frequently and solicit appropriate user feedback
  • Drive decision making and escalate key issues quickly
  • Keep the organization’s vision and values at the forefront of decision making and action
• Design Control Expertise
  • Drive early design decisions with sound understanding of design control, clinical risks, and evaluation strategy
  • Drive design validation testing strategy for new products, and get alignment on the strategy with key regulatory and engineering stakeholders
  • Support product launches and collect early field feedback in collaboration with product management
  • Closely collaborate with other organizations within the company, including design, marketing, regulatory, human factors, training, product management, and sales throughout product development and testing

Skill/Job Requirements:

• B.S. in Mechanical Engineering, Biomedical Engineering, or similar, advanced degree preferred
• Minimum of 6 years of relevant experience in medical device industry required
• Ability to understand complex robotic products
• Experience collaborating with physicians and collecting feedback on clinical use of the product
• Experience working in cross-functional teams and proven ability to cultivate collaboration across multiple disciplines (marketing, regulatory, quality, product design, engineering, human factors) to ensure project success
• Experienced in driving complex medical devices from concept to market
• Experience performing clinical risk analysis and developing design validation strategy, protocol creation and testing
• Experience leading hands-on product evaluation testing in a pre-clinical lab setting
• Fluent in medical terminology and sound knowledge of anatomy
• Self-starter needing minimal supervision
• Self-confident and able to react quickly under pressure
• Ability to adapt priorities in a fast paced, dynamic, product development team
• Excellent verbal and written communications skills required including presentation of technical content
• Ability to travel up to 25% of the time, internationally and domestic

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal 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.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. 

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

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.