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Manager Clinical Research Engineering

4 months ago

Sunnyvale, California, United States Intuitive Surgical Full time
Job Description

The Team

The Advanced Research team at Intuitive is a cross-functional team dedicated to the creation of innovative medical technologies and robotic systems. We develop transformational technologies in order to address the major pain points and unmet needs in healthcare. Our goal is to revolutionize the future of healthcare by developing platforms and technologies that empower providers and teams to deliver life-enhancing care.

Primary Function of the Position The Clinical Research Engineering Manager will guide and mentor a talented Clinical Engineering team responsible for development of a robotic platform in early concept. The person will foster relationships across functions and along with the team communicate the customer need, safety risks, and feature value for a specialty where Intuitive does not currently have a commercial presence. The person will be a key stakeholder in selecting the winning concepts that balance performance, program risk, and commercial viability. The person will have a track record of effectively working closely with hardware and software engineering teams, Regulatory, Clinical Affairs, Quality, and more to collaboratively develop the novel system.

Essential Job Duties

The person will:

  • Mentor an exceptional team of self-directed Clinical Engineers, encouraging an enthusiastic, exploratory, and innovative mindset in the team.
  • Encourage the long-term professional development of the team by coaching and providing feedback in an ongoing basis.
  • Establish sub-team priorities consistent with program goals. Facilitate priority alignment and track progress, adhering to budget and timelines.
  • Identify, isolate, and plan to resolve high-risk questions that stand between today and confidence that we can meet the customer needs and program targets. In other words, reduce risks until they become implementation tasks.
  • Bring a clinical voice to the design team by becoming an Intuitive resource on how procedures are currently done today, with an eye toward what they can become in the future.
  • Work with key subject matter experts, physicians, and other stakeholders to identify clinical goals and translate those needs for user-centric design concepts.
  • Be a key contributor in the design iteration process by developing and executing an experimental strategy to assess performance and safety of prototype designs.
  • Research, develop, and design novel pre-clinical models.
  • Develop novel procedures and workflows for novel robotic platform.
  • Develop research plans and performance metrics for the pre-clinical assessment of a novel robotic platform to validate the safety and effectiveness of proposed designs. Provide data-driven feedback to the design team.
  • Develop and execute a pre-clinical evaluation strategy in advance of human trials and for regulatory submissions.
  • Drive on-site execution of early feasibility, pilot, and pivotal clinical trials including user training and case support.
  • Keep the organization's vision, values, strategy, and goals at the forefront of decision-making and action