Staff Business Systems & Process Analyst

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Primary Function of the Position The Staff Process and Business Systems Analyst / Engineering Document Control Specialist supports engineering and manufacturing teams by managing and governing engineering documentation, product structures, and change control activities. The role ensures accurate creation, revision, release, and maintenance of documents, drawings, software artifacts, and Bills of Materials (BOMs) using enterprise ALM, PDM, PLM and ERP systems. This position also drives process improvements, data integrity, compliance, and effective implementation of business systems features while providing mentorship and cross-functional support. Roles and Responsibilities Provide end-to-end support for engineering documentation and change control activities, ensuring compliance, accuracy, and timely execution across engineering and supply chain organizations. Partner with engineering teams to assess documentation, BOM, and change order needs, define scope, prioritize work, and plan execution based on business and project priorities. Serve as a subject matter expert for engineering and manufacturing business systems, promoting consistent usage, data integrity, and alignment across documentation, CAD, and BOM structures. Maintain and govern controlled documents, templates, and records in accordance with quality system requirements and industry best practices. Identify gaps, inefficiencies, and compliance risks within documentation and change processes, and support continuous improvement initiatives to streamline workflows and reduce manual effort. Support engineering business systems enhancements and releases by contributing to requirements analysis, definition, validation, and user acceptance testing. Ensure alignment between CAD models, drawings, BOMs, and released documentation across enterprise platforms. Contribute to master data governance and standardization efforts to improve accuracy, consistency, and scalability of engineering data. Train and mentor engineering colleagues on documentation standards, change control practices, and effective use of ALM, PDM, MRP, and PLM tools. Collaborate effectively in a multi-team, fast-paced environment while managing multiple priorities and maintaining high attention to detail. Required Skills and Experience Documentation for Product Design, Product Verification/Validation, Manufacturing process, and Equipment design/qualification, Preventative Maintenance/Calibration documentation. Strong proficiency and working experience with Agile PLM or Oracle Cloud PLM systems. Experience with Polarion as ALM tool. Experience working in CAD and CAD PDM systems (e.g., SolidWorks, Windchill). Proficiency with Microsoft Office applications (Word, Excel, Outlook, Copilot) and Adobe Acrobat. Working knowledge of engineering documentation control, change management, and product data management concepts. Proven critical thinking, business process analysis, and solutioning skills. Experience working in a fast-paced, high‑transaction engineering or manufacturing environment. Strong ability to collaborate across multiple teams and disciplines. Excellent organizational, written, and verbal communication skills. Demonstrated ability to learn new concepts and systems quickly and manage multiple priorities effectively. Preferred Skills and Experience Understanding of medical device regulatory requirements and quality system expectations, including documentation, change records, and record traceability (FDA 21 CFR Part 820/11, ISO 13485). Experience supporting documentation or change order reviews within a Quality organization. Strong appreciation for training compliance and adherence to defined procedures when executing processes. Required Education and Training Minimum of 5 years of experience supporting documentation creation, revision, and release in an engineering environment within the medical device industry (electro‑mechanical and/or software). Minimum of an Associate Degree; Bachelor's degree preferred. 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.

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