Staff Quality Engineer - New Product Development

Job description

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  Leads initiatives that change how quality is executed across multiples BUs or sites  Establishes standards, frameworks, or methodologies adopted beyond local teams  Serves as escalation owner for high impact product quality & compliance risks  Leadership of critical product, process investigations and audits.  Indentification, execution and advise on strategic quality projects with company wide impact.  Ownership of quality investigations for complaints and non-conformances.  Author, review, and approve QA documentation, protocols  Leadership of critical CAPAs  Serves 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). Provides industry expertise.  Advise cross-functional teams on quality requirements.  Indentification and ownership of continuous improvement projects.  Design Control and Risk Management Stewardship: Planning and execution of design controls, risk management, and design verification/validation for new products o Advocate product design history file and ensure compliance with internal processes and external standards and regulations. o Understand user needs and assure they are translated to the design, while ensuring compliance with usability and human factors standards and regulations. o Partner with engineering to define design inputs, design outputs, and traceability matrices. o Contribute to the strategy and execution of risk-based design verification and validation. o Accountable for overall risk management file: participate and support the development of product risk management file, to analyze and assess the product risks associated with user, design, process and supplier.  Support design controls activities associated with new product development. Advocate and ensure the transfer of reliable and scalable designs to manufacturing o Review and provide feedback on design architecture, selections, requirements, and drawings from early design. o 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 BU or enterprise level  Outcomes are adopted and sustained beyond the business unit  Develops other Senior QEs into future Staff level leaders  Influences senior leadership decisions through data, judgment, and presence  Acts as a role model for quality culture and leadership behaviors Required Experience and Education  Minimum 12 years of experience in QE/QA and bachelor’s degree in engineering or relevant discipline, or 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, 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 (<25 lbs) and PPE for production or regulated areas. Due 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 Notices U.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 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 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. 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.