Staff Quality Engineer

It 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. Primary Function of Position This role drives enterprise‑level quality outcomes by leading strategic initiatives, shaping quality practices, and influencing decisions across business units. The Staff QE operates with broad autonomy and is recognized as a technical and leadership authority. Essential Job Duties Lead initiatives that change how quality is executed across multiple business units or sites Establish standards, frameworks, or methodologies adopted beyond local teams Serve as escalation owner for high‑impact product quality and compliance risks Lead critical product, process investigations and audits Identify, execute, and advise on strategic quality projects with company‑wide impact Own quality investigations for complaints and non‑conformances Author, review, and approve QA documentation and protocols Lead critical CAPAs Serve as subject matter expert in critical audits Analyze and interpret advanced quality data and KPI trends Mentor junior and senior engineers in technical expertise Ensure compliance with company and regulatory standards (GMP, ISO, FDA) Advise cross‑functional teams on quality requirements Identify and own continuous improvement projects Plan and execute design controls, risk management, and design verification/validation for new products Advocate product design history file and ensure compliance with internal processes and external standards and regulations Understand user needs and ensure they are translated to design while ensuring compliance with usability and human factors standards and regulations Partner with engineering to define design inputs, outputs, and traceability matrices Contribute to the strategy and execution of risk‑based design verification and validation Accountable for overall risk management file, analyzing and assessing product risks associated with user, design, process, and supplier Support design controls activities associated with new product development and transfer of reliable and scalable designs to manufacturing Review and provide feedback on design architecture, selections, requirements, and drawings from early design Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of scalable designs into production Breadth of Impact and Leadership Demonstrated impact at business unit or enterprise level Outcomes adopted and sustained beyond the business unit Develop other Senior QEs into future Staff‑level leaders Influence senior leadership decisions through data, judgment, and presence Act as a role model for quality culture and leadership behaviors Required Experience and Education Minimum 12 years of experience in QE/QA and a bachelor’s degree in engineering or a relevant discipline, or an equivalent combination of education and experience. Required Knowledge, Skills and Abilities Advanced understanding of quality principles and methodologies Advanced data analysis and data interpretation skills Expert ability to resolve quality issues Respected ability to foster a quality culture Expert communication and team collaboration skills, ability to influence stakeholders, executive presence Expertise with evolving quality standards, tools, and technologies Strong ability to mentor and teach junior engineers Physical Requirements Office, lab, production, and site travel as needed Frequent computer and inspection work Occasional lifting ( Additional Requirements Due to the nature of our business and the role, 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. Equal Employment Opportunity 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. Export Controls In accordance with U.S. Export Administration Regulations, 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. Applicants for such roles will be notified of any licensing or technology control plan requirements. #J-18808-Ljbffr