Sr. Clinical Development Engineer, Endoluminal

Company Description

At Intuitive, we are united behind our mission: 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.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world 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 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 advance the world of minimally invasive care.

Job Description

Primary Function of Position:

This Sr. Clinical Development Engineer, Endoluminal (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

Qualifications

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 wi