Roles and responsibilities
Essential duties
Own the end-to-end CSL program, serving as the primary driver for planning, execution, delivery, and stakeholder alignment across RA, IT, Quality, Operations, suppliers, and logistics sites.
Lead Country-Specific Labeling requirements management, partnering with Regulatory Affairs (RA/RSAs) to interpret country regulatory assessments and convert them into clear, testable requirements.
Drive schema development with IT/engineering teams by defining requirements, acceptance criteria, traceability, and change impacts; ensure schemas are scalable and aligned to enterprise standards.
Lead integration delivery for labeling capabilities with SAP and warehouse management systems, coordinating dependencies, interface readiness, and cutover planning.
Coordinate with warehouse logistics teams and external partners to implement labeling workflows, including label printing/handling, verification steps, exception management, and training/readiness.
Facilitate label template design discussions to ensure templates work as expected across countries, products, printer constraints, and warehouse execution.
Manage workstreams related to supplier-printed labels, including specifications alignment, readiness tracking, issue triage, and operational deployment coordination.
Define and structure User Acceptance Testing (UAT) for labeling (test strategy, test cases, traceability, execution coordination, defect management, and sign-off).
Partner with Quality to manage labeling-related non-conformances (NCs) and CAPAs, supporting investigation coordination, corrective action execution, and effectiveness checks.
Establish and maintain program documentation (program plans, RAID logs, requirements traceability, SOP/work instructions impacts, release notes) and drive standardization of CSL delivery processes.
Drive continuous improvement initiatives to reduce labeling errors, shorten cycle times, improve audit readiness, and strengthen operational controls.
Education, experience, skills and training
Education and experience
Minimum of bachelor’s degree in engineering or a related field.
Minimum of 8+ years of experience working in labeling, hardware, system production, or test environment primarily in healthcare industry.
Technical skills
Lead technical, cross-functional programs end-to-end (requirements → build/config → testing → deployment) in a regulated and/or operationally complex environment.
Strong ability to translate regulatory labeling requirements into system requirements, schemas, templates, and warehouse-operational processes.
Demonstrated ability to coordinate across RA, IT/engineering, Quality, warehouse operations/logistics, suppliers, and external partners (3PLs).
Hands-on experience running UAT (planning, traceability, execution coordination, defect triage, and release readiness).
Experience building and maintaining enterprise program artifacts: requirements traceability, release governance, cutover plans, training/readiness, and stakeholder reporting.
Other skills and abilities
Able to learn and apply established procedures in a reliable and consistent manner.
Strong communication skills (written and verbal) with the ability to drive alignment, decisions, and execution across multiple stakeholders.
Ability to lead and deliver in a matrix environment.
Strong problem-solving skills and ability to be self-managed in a fast-paced environment utilizing agile/sprint methodologies.
Quick learner with ability to understand complex products and processes.
Ability to work in a team environment.
High level of attention to technical details and accuracy.
Ability to work independently and with minimal supervision
Ability to multitask, and handle tasks with competing priorities effectively
Proficient with MS Office applications
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.
Accommodation & Accessibility Notice
Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at HRHelpNow@intusurg.com.
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.
