Staff, Document Specialist & Business Systems Analyst - Engineering Group
Core
Lead PLM 2.0 evaluation, implementation, and global asset/tool management to improve product lifecycle processes, documentation governance, and cross-system traceability in regulated manufacturing.
Role type
Staff Business Systems Analyst & Document Control Specialist
Builds
Future-state PLM processes, global asset lifecycle strategies, and controlled documentation systems for Engineering and downstream operations.
Domain
Medical device manufacturing / Regulated engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
PLM platform evaluation and implementation, engineering document control, change management, requirements management, process design, fit-gap analysis, BOM governance, stakeholder influence, cross-functional project leadership, regulatory compliance knowledge (FDA 21 CFR, ISO 13485)
Preferred skills
SAP S4/ME/MDG, MES/ERP integration, digital thread enablement, master data governance, analytics reporting (Tableau, Power BI), Kaizen facilitation
Technologies
Oracle Agile, Oracle Cloud PLM, Windchill, Teamcenter, Enovia, SAP S4, Polarion, Snowflake, Tableau, Power BI
Responsibilities
Lead PLM platform evaluation, selection, and deployment; design future-state processes and manage requirements; govern engineering documents, ECO/ECR processes, and traceability; support global asset and tool lifecycle management; drive cross-functional initiatives from concept to completion; coordinate testing, training, and change management; mentor document specialists and analysts on standards and compliance.
Seniority
Staff, independent contributor with strategic influence and mentorship
