Research Scientist/Engineer 4

Primary Function of Position:

This Sr. Clinical Development Engineer (CDE) position reports to the Sr. 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.  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 include:

• Clinical and Technical Knowledge

  • Apply in-depth knowledge of the clinical procedure and of medical technology in order to become an expert within the company on Intuitive’s products and clinical applications

  • Collaborate with physicians and key clinical users to understand the clinical need

  • Provide a clinical voice for design and evaluation of Intuitive’s products

  • Assess potential clinical risks and mitigations to drive appropriate product design

  • In-depth technical understanding of the Intuitive products and adjunct medical device technology that includes mechanical, software, algorithms, 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

  • 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