Sr. Clinical Development Engineer

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 Clinical Development Engineering Manager on the Ion Endoluminal platform. In this position, 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. This position will also allow exploration of future robotic clinical applications and solutions.Roles and Responsibilities:The responsibilities for this position include:Clinical and Technical knowledgeApply in-depth clinical knowledge and technical system understanding in defining and developing products based on clinical needsCollaborate with physicians and key clinical users on clinical procedure development and understanding product feedbackClearly define clinical need and requirements for productDevelop test models and test methods for clinically relevant product evaluations.Assess potential clinical risks and propose mitigations as an input to product designObserve cases and communicate assessment of robotic value and/or opportunitiesContribute expertise into clinical protocol design and strategyProduct LeadershipParticipate in early design investigation teams that are lean and efficient with a focus on product enhancements & new product ideas.Drive frequent stakeholder alignment 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 actionEducate cross functional team on clinical workflowSupport product launches and/or clinical trials and collect early field feedbackDesign ControlConduct clinical risk analysis for new products or updatesLead testing and clinical evaluations of new product featuresCollaborate with cross functional team members including regulatory, human factors, training, engineering and product management to determine design and development key inputsDrive design validation testing strategy for new products and get alignment on the strategy with key regulatory and engineering stakeholdersQualificationsSkill/Job Requirements:Masters or PhD in Mechanical Engineering, Controls Engineering, Biomedical Engineering or similarMinimum of 4 years of clinical development and design control experience including the MSExperienced in driving medical device products and features from concept to marketExperience collaborating with physicians and collecting feedback on clinical use of the productsExperience understanding clinical harms and performing clinical risk analysisFluent in medical terminology and sound knowledge of anatomyNice to haves: Experience 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 success. Experience developing design validation strategy, protocol creation and testingExperience leading hands-on product evaluation testing in a pre-clinical lab settingSelf-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 including presentation of technical contentTravel: Ability 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.This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law.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.SummaryType: Full-timeFunction: EngineeringExperience level: AssociateIndustry: Medical Device