Company DescriptionIt started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies-like the da Vinci surgical system and Ion-have transformed how care is delivered for millions of patients worldwide.We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful-because every improvement we make has the potential to change a life.If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.Job DescriptionPrimary Function of Position:This Sr. Clinical Development Engineer (CDE) position reports to the 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 of significant scope and complexity. 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 that include:Clinical and Technical KnowledgeApply in-depth knowledge of the clinical procedure and of medical technology to become an expert within the company on Intuitive's products and clinical applicationsCollaborate with physicians and key clinical users to understand clinical needsProvide a clinical voice for design and evaluation of Intuitive's productsDevelop test models and test methods for clinically relevant product evaluationsAssess potential clinical risks and mitigations to drive appropriate product designApply in-depth technical understanding of the Intuitive products and adjunct medical device technology that includes mechanical, software, algorithms, and electronics aspects of the deviceProduct leadershipDrive product discovery in collaboration with product management and product design teams by being the internal champion of clinical needLead early design investigation teams that are lean and efficient for product enhancements & new product ideasCreate best practices guidelines and white papers, and educate cross functional teams on clinical workflowSupport clinical study and/or product launch through training and case supportLead post market investigation by conducting clinical risk assessment, clinical workflow investigation and pre-clinical testing for critical field issuesDrive stakeholder alignment frequently and solicit appropriate user feedbackDrive decision making and escalate key issues quicklyKeep the organization's vision and values at the forefront of decision making and actionDesign Control ExpertiseDrive early design decisions with sound understanding of design control, clinical risks, and evaluation strategyDrive design validation testing strategy for new products, and get alignment on the strategy with key regulatory and engineering stakeholdersSupport product launches and collect early field feedback in collaboration with product managementClosely collaborate with other organizations within the company, including design, marketing, regulatory, human factors, training, product management, and sales throughout product development and testingQualificationsSkill/Job Requirements:B.S. in Mechanical Engineering, Biomedical Engineering, or similar, advanced degree preferredMinimum of 6 years of relevant experience in medical device industry requiredAbility to understand complex robotic productsExperience collaborating with physicians and collecting feedback on clinical use of the productExperience working in cross-functional teams and proven ability to cultivate collaboration across multiple disciplines (marketing, regulatory, quality, product design, engineering, human factors) to ensure project successExperienced in driving complex medical devices from concept to marketExperience performing clinical risk analysis and developing design validation strategy, protocol creation and testingExperience leading hands-on product evaluation testing in a pre-clinical lab settingFluent in medical terminology and sound knowledge of anatomySelf-starter needing minimal supervisionSelf-confident and able to react quickly under pressureAbility to adapt priorities in a fast paced, dynamic, product development teamExcellent verbal and written communications skills required including presentation of technical contentAbility to travel up to 25% of the time, internationally and domesticAdditional InformationDue to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.Intuitive is an Equal 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.Mandatory NoticesU.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee'sstart date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
Job Title
Sr. Clinical Development Engineer, Endoluminal