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Sr Clinical Development Engineer

Company: Intuitive Surgical
Location: Sunnyvale
Posted on: May 3, 2021

Job Description:

At Intuitive, 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. Our mission is our guiding force; our culture is the DNA that makes us unique. As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare's complex challenges. We believe a great idea can come from anywhere"inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse 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 strive to 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 help to advance the world of minimally invasive care.Primary Function of Position:The Senior Clinical Development Engineer (CDE) uses their in-depth knowledge of the da Vinci Surgical System to work with design engineers and clinicians to define, develop, and validate the clinical function of new products within our multi-port and single-port surgical robotic system platforms. The CDE is responsible for establishing and validating data-driven clinical requirements to ensure a high-quality patient outcome and for conveying the clinical value throughout the organization.Roles andResponsibilities:This position has responsibility and authority for the following:New Product Development:Applying in-depth knowledge of the operating room environment and of the da Vinci Surgical Systems to become an expert on the clinical application of Intuitive's productsWorking with clinical sales representatives, surgeons, and marketing to identify clinical needs and complementary devices in the marketplaceCollaborating closely with product management and product development teams to define clinical performance goals and potential risks for new productsCollaborating with research teams to help with quick design iteration and assessment of productsAssessing and documenting clinical risks, and advising engineering regarding risks and mitigationsCollaborating with other organizations within the company as needed: design engineering, regulatory, human factors, training, quality, manufacturing, marketing, and salesClinical Laboratory & Field Work:Conducting pre-clinical validations and design iteration assessments of products both internally and with external key opinion leadersConducting formal validation testing for new products, product updates and modifications to existing designs, to ensure the clinical safety and efficacy of the productSupport clinical evaluation of new or enhanced products at key customer sitesIdentify potential product enhancements & new product ideas by applying an analytical approach to understanding the clinical needs of surgeonsDesign History:Clinical Risk Analysis Product Requirement DocumentsClinical Design Validation/Chronic Animal Study/Histopathology Protocols & Reports510K / regulatory submission content User manual and training documentation Other:Keeps the organization's vision and values at the forefront of decision making and actionPerforms other duties as required to support the company's overall strategy and goalsSkill/Job Requirements:Minimum M.Sc. Degree in Mechanical Engineering, Biomedical Engineering or similarMinimum of 6 years of experience in medical device industry requiredExperience working with surgeons in an operating room environmentFluent in surgical terminology and sound knowledge of anatomy and surgical techniqueExcellent mechanical aptitude, and intuition for spatial relations, including the ability to understand complex mechanical productsExcellent teamwork skills with proven ability to cultivate collaboration across multiple disciplines to ensure project successEffective communication skills (verbal, written, presentation)Proven success recognizing critical issues and driving them to closure by taking coordinated actionExperience mentoring individuals in junior positions on teams and leading by exampleSelf-starter needing minimal supervisionSelf-confident and able to react quickly under pressureAbility to travel up to 25% of the time, internationally and domesticIntuitive is an Equal Employment 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. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.SDL2017

Keywords: Intuitive Surgical, Sunnyvale , Sr Clinical Development Engineer, Other , Sunnyvale, California

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