About this role
Primary Function of Position:
The Business Systems and Change Analyst is responsible for processing change orders and successfully implementing system and processes improvements in the Document Control department. The position represents Document Control department in projects and collaborates with cross-functional departments, ensuring Compliance with Intuitive Document Control Standards and Regulatory requirements. Work closely with the senior Business and Systems Process Analysts to draft and review requirements, test scripts and execute PLM system and process updates. This position reports directly to the Senior Manager, Document Control.
Essential Job Duties
Execute improvement activities for the PLM system (Agile) and Document Control ProcessesRepresent Document Control during requirements definition phase of projectsParticipate in planning sessions for approved projects to provide input to requirementsParticipate in multiple project teams. Work with business owners to ensure the team understands users’ business activities and that the acceptance criteria are defined.Participate in daily stand-ups, resolve conflict, and escalate as requiredCreate test scripts related to PLM and Document Control projects. Execute User Acceptance testing.Work with Computer System Validation (CSV) groups in Regulatory and IT to ensure project compliance with regulatory and Intuitive CSV policies and proceduresIdentify and resolve project issues and manage project dependencies within the Document Control environment to keep the critical path on track.Update impacted procedures and ensure all required documentation is updated and released at the time of project implementationSupport and Contribute to the Agile Training Forum. Provide input to slide content related to processes and PLM system questions.Review, assess and implement approval matrix requests. Provide support in approval matrix improvements.Review and assess Document Control tickets to understand issue details and requirements. Resolve the complex Document Control tickets.Become embedded in the process – spend a portion of time processing ECOs and responding to internal customer issuesSupport the Senior System and Business Analyst on assigned tasks and projectsProcess a daily quota of change orders to support the businessProcess complex change orders accurately and timely using the electronic documentation system, based on professional concepts and company objectives.Audit documentation changes for accuracy, completeness, and compliance with language, procedural, and regulatory requirements.Ensure changes are in a closed loop with all discrepancies addressed before release, where analysis of situations or data requires knowledge of regulatory and change control principles.Provide clear verbal and written communication to internal customers, including guidance to originators on correcting issues or discrepancies.Promptly respond to questions and issues raised by Originators and ApproversRaise issues applicable to the Document Control team and offer detailed solutions and alternatives with justification for actions.Maintain data integrity within Agile form fields and update item forms within Agile to accommodate changes within company processes and requirementsHave in-depth Agile system and change control processes knowledge in order to troubleshoot issues as needed and know when to escalate them to ITUnderstand how Agile links to other systems within and outside Intuitive. Provide support on Agile integration-related requests.Update Document and Change Control procedures as neededRequired Skills and Experience
Experience in a Regulatory/Quality organization in a medical device companyExperience with and knowledge of both the functional and technical aspects of a PLM system, Agile preferredknowledge of Change Control principles for Document Control and IT systemsExperience working on process and system improvement projectsWorking knowledge of Microsoft Office products (MS Word, MS Excel, MS Visio)Strong critical and analytical thinking and problem-solving skillsStrong attention to detail.Planning and organizing adaptability; ability to react to project adjustments & alterations promptly and efficientlyExperience working with 5+ person cross-functional project teamsAbility to be both “hands on” and to work in a team-oriented, collaborative environmentAbility to work in a high stress, ever changing environmentAbility to communicate clearly and effectively to both business stakeholders and technical team members (e.g. IT)Self-starter, able to work with minimal supervision#LI-Hybrid
Required Education and Training
University degree with a minimum of 6-10 years of equivalent work experience.Quality System Regulations and ISO requirements TrainingProject Management TrainingQuality Systems Validation TrainingWorking Conditions (As applicable - This role requires sedentary and repetitive working conditions, some overtime required. 15% travel)
Preferred Skills and Experience
PLM System technical and functionality
Project Management
Medical Devices
Intuitive is an Equal Employment 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.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
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.
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.