Senior Quality Engineer - Multiport Da Vinci

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: Senior Quality Engineer supports product development from concept through commercializationand will serve as the core team member for the cross-functional product developmentteam. Senior Quality Engineer will provide expertise and guidance to the team on design controland risk management, Software Development Life Cycle, and Design for Reliability andManufacturing. In addition, this position will play an effective role to ensure that the developedproducts meet quality standards consistent with Intuitive’ s quality processes, while meeting allexternal design control and regulatory requirements.Essential Job Duties (Specific responsibilities and tasks an individual would be expected toperform in the role. Additional job duties may be determined by functional managers.Proven contributor to the planning and execution of designcontrols, risk management, and designverification/validation for new productsParticipate and support the development of productdesign history file and ensure compliance to internalprocesses and external standards and regulations.Understand user needs and assure they are translated to the design, whileensuring compliance to usability and human factors standards and regulations.Partner with engineering to define design inputs, design outputs, and traceabilitymatrices.Contribute to the strategy and execution of risk-based design verification andvalidation.Participate and support the development of product risk management file, toanalyze and assess the product risks associated with user, design, process andsupplier. Ensure reliable and scalable designs to transferred to manufacturingReview design architectures, selections, requirements, and drawings from earlydesignCollaborate with manufacturing, purchasing, test engineering, and supplierengineering to facilitate transfer of scalable designs into production.Assist in supplier selection, qualification, certification, and performanceimprovement.Contribute to new product development Technical Reviews and Design Reviews. Support Regulatory Affairs with creating submissions and responding to submissionquestions. Support internal and external audits, including preparation and direct interaction withauditors.QualificationsRequired Skills and Experience Minimum 8+ years of working experience in Quality Engineering, minimum 4 years inelectromechanical systems and/or software design and developmentSolid understanding of design control and risk managementfrom early design and development throughcommercialization; Demonstrated experience withelectromechanical system from concept through launch isrequired. Experience with medical standards compliance, including ISO 13485, ISO 14971 andFDA Quality System Regulations with a focus on design controls and design optimization. Able to navigate quality system with minimal oversight on personal projects. Balanced risk decision making to drive product quality, gain consensus, and work throughtechnical challenges. Solves complex problem with minimal oversight. Able to articulate complex information to teams, including executive management.Required Education And Training Education: Minimum bachelor’s degree in STEM, electrical, mechanical, systemengineering, math, or physics.Additional 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 CFR743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who 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’s start 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 onbusiness 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 theCandidate’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.Base Salary Range Region 1:$150,100 - $215,900Base Salary Range Region 2: $127,600 - $183,500Shift: DayWorkplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.