Intuitive
Senior Clinical Development Engineer Digital Products
Intuitive, Orlando, Florida, us, 32885
Job Description
Primary Function of the PositionThe Senior Digital Clinical Development Engineer (CDE) uses their in-depth knowledge of the surgical environment and medical technology to work with design engineers and clinicians to define, develop, and validate the clinical function of new digital products within our multi-port and single-port surgical robotic platforms. The primary focus of the CDE is to establish and validate data-driven clinical and user-facing requirements to ensure a high-quality patient outcome.Essential Job DutiesApply in-depth knowledge of the operating room environment and of the da Vinci Surgical Systems to become an expert within the company on the clinical application of Intuitive’s productsProvide a clinical voice to product development by defining and assessing clinical performance of new productsCollaborate with marketing partners and clinicians to identify and understand clinical needsUse an analytical approach to identify potential product enhancements and new product ideasTake an active role in new product development teams, including contributing to design reviews, and providing design guidance to engineering design teamsAssess and document clinical risks, and identify appropriate mitigationsConduct pre-clinical testing to validate the safety and efficacy of new productsSupport regulatory documentation and submissionsProvide subject matter expertise to user manual and training documentation developmentSupport clinical evaluation of new products at key customer sitesMaintain current knowledge of clinical applications of Intuitive’s productsKeep Intuitive’s vision and values at the forefront of decision makingPerform other duties as required to support the company’s overall strategy and goalsAssist in the preparation of regulatory submissions, such as 510(k)s or IDEs, ensuring compliance with relevant regulatory requirements.
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Primary Function of the PositionThe Senior Digital Clinical Development Engineer (CDE) uses their in-depth knowledge of the surgical environment and medical technology to work with design engineers and clinicians to define, develop, and validate the clinical function of new digital products within our multi-port and single-port surgical robotic platforms. The primary focus of the CDE is to establish and validate data-driven clinical and user-facing requirements to ensure a high-quality patient outcome.Essential Job DutiesApply in-depth knowledge of the operating room environment and of the da Vinci Surgical Systems to become an expert within the company on the clinical application of Intuitive’s productsProvide a clinical voice to product development by defining and assessing clinical performance of new productsCollaborate with marketing partners and clinicians to identify and understand clinical needsUse an analytical approach to identify potential product enhancements and new product ideasTake an active role in new product development teams, including contributing to design reviews, and providing design guidance to engineering design teamsAssess and document clinical risks, and identify appropriate mitigationsConduct pre-clinical testing to validate the safety and efficacy of new productsSupport regulatory documentation and submissionsProvide subject matter expertise to user manual and training documentation developmentSupport clinical evaluation of new products at key customer sitesMaintain current knowledge of clinical applications of Intuitive’s productsKeep Intuitive’s vision and values at the forefront of decision makingPerform other duties as required to support the company’s overall strategy and goalsAssist in the preparation of regulatory submissions, such as 510(k)s or IDEs, ensuring compliance with relevant regulatory requirements.
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