Staff, Document Specialist & Business Systems Analyst - Engineering Group

Intuitive•Sunnyvale, CA
•$55 - $94•Hybrid

About The Position

The Staff, Document Specialist & Business Systems Analyst leads documentation governance, engineering change management, and product data lifecycle activities supporting the Engineering group. The role provides documentation and change-order support for creating, revising, and releasing engineering documents, drawings, software artifacts, and Bills of Materials (BOMs) using ALM, PDM, MRP, and PLM systems. It ensures documentation integrity, compliance, traceability, and effective product data governance. The role also leads process, data, and business systems initiatives, especially the evaluation, selection, and implementation of PLM 2.0, as well as broader Engineering process improvement. Responsibilities span business systems analysis, document control, process design, and change management to improve product lifecycle processes, data quality, compliance, documentation governance, and cross-system traceability across Engineering and downstream stakeholders. This is an Engineering Business Systems role, not an IT solution position. As a Staff-level position, it independently leads complex cross-functional initiatives, influences senior stakeholders, contributes to company objectives, and mentors others. The role is based in Sunnyvale, California, with a set schedule of four onsite days and one remote day per week. Travel may be required on an as-needed basis, at 10%.

Requirements

  • Bachelor’s degree in Engineering, Information Systems, Computer Science, Business Systems, or a related technical discipline.
  • At least 15 years of related experience, or 12 or more years with a Master’s degree, in engineering, manufacturing, business systems, or regulated product development environments.
  • Strong expertise in engineering document control, change management, product data governance, BOM management, traceability, and compliance.
  • Experience with PLM platforms such as Oracle Agile, Oracle Cloud PLM, Windchill, Teamcenter, Enovia, or similar, and related business systems including ALM, CAD/PDM, ERP, or MES.
  • Proven experience leading PLM implementations, migrations, process redesign, platform consolidations, or major system enhancements.
  • Strong business systems analysis skills, including requirements management, process mapping, fit-gap analysis, testing, and deployment support.
  • Working knowledge of FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO 13485, electronic records, documentation controls, and audit-ready quality systems.
  • Strong understanding of Manufacturing Engineering, product development processes, CAD/PDM-controlled design data, Supply Chain, and Planning functions.
  • Demonstrated ability to lead cross-functional initiatives, influence senior stakeholders, solve complex business problems, and operate independently.
  • Excellent communication, facilitation, coaching, prioritization, and influence-without-authority skills.

Nice To Haves

  • Master’s degree.
  • Medical device experience; aerospace or other highly regulated manufacturing experience is also considered.
  • Experience with SAP S/4HANA, SAP ME, SAP MDG, Fiori, MES, ERP integrations, or enterprise business system transformations.
  • Experience with Polarion, ALM, CAD/PDM, SolidWorks, Windchill, or platforms supporting requirements, design, manufacturing, quality, and V&V data.
  • Knowledge of digital thread, structured data reuse, master data governance, product data management, configuration control, and enterprise data standards.
  • Experience with analytics and reporting solutions such as Tableau, Power BI, Snowflake, SAP BO/BOXI, or similar platforms.
  • Experience facilitating workshops, Kaizens, solution evaluations, change impact assessments, and user adoption activities.

Responsibilities

  • Create, revise, release, and maintain engineering documents, drawings, software artifacts, BOMs, and engineering changes (ECO/ECR) in ALM, PDM, MRP, and PLM systems, ensuring compliance, traceability, and documentation integrity.
  • Lead PLM 2.0 evaluation, selection, implementation, and adoption, including requirements management, future-state process design, fit-gap analysis, testing, deployment, and business readiness.
  • Establish and maintain governance for product data, BOMs, master data, metadata, configuration control, and cross-system traceability across PLM, ERP, MES, QMS, and related platforms.
  • Translate business needs into scalable processes, system requirements, reporting solutions, and implementation roadmaps that improve efficiency, compliance, and data quality.
  • Lead cross-functional initiatives from concept through implementation, including planning, resource coordination, risk management, change management, training, cutover activities, and post-go-live stabilization.
  • Partner with Engineering, Manufacturing, Quality, Regulatory, Supply Chain, Service, IT, and global stakeholders to align priorities, resolve complex issues, and drive execution.
  • Coach users and team members on document control, change management, PLM processes, business systems best practices, and compliance requirements.
  • Prioritize work and drive outcomes with limited supervision; escalate risks and strategic decisions as appropriate.

Benefits

  • Market-competitive compensation packages, including base pay, incentives, benefits, and equity.
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