The PLM Analyst is responsible for supporting, configuring, and optimizing the Oracle Fusion Cloud PLM within a regulated medical device environment. This role ensures seamless integration between Oracle Fusion Cloud PLM, SAP S/4HANA, NiceLabel, and Cornerstone, while maintaining compliance with FDA, ISO 13485, and internal Quality Management System (QMS) requirements.
The PLM Analyst partners closely with R&D, Quality, Regulatory, Manufacturing, Supply Chain, and IT to manage product data, engineering changes, documentation, and system integrations across the product lifecycle.
Essential Duties and Responsibilities
- Serve as the primary administrator and subject-matter expert for Oracle Fusion Cloud PLM.
- Configure workflows, attributes, user roles, permissions, and lifecycle states.
- Maintain product structures, BOMs, specifications, drawings, and metadata.
- Support system upgrades, enhancements, and quarterly Fusion Cloud releases.
- Manage and support ECO, MCO, CR, Deviations, and other change workflows.
- Ensure accurate routing, approvals, and traceability of changes.
- Maintain DHF, DMR, and technical documentation within PLM.
- Support New Product Introduction (NPI/NPD) and sustaining engineering activities.
- Support QMS processes managed within PLM or integrated systems.
- Support Computer System Validation (CSV) activities (IQ/OQ/PQ, evidence, traceability).
- Participate in internal and external audits related to Fusion PLM and IT systems.
- Support and monitor Oracle Fusion Cloud PLM integrations with other systems.
- Coordinate issue resolution with SAP, middleware, and integration teams.
- Validate data consistency across systems.
- Provide Tier 2/3 support for Oracle Fusion Cloud PLM users.
- Create and maintain SOPs, work instructions, and training materials.
- Train users on Oracle Fusion PLM workflows, best practices, and compliance requirements.
- Support access management and role design in coordination with IT Security.
- Identify opportunities to streamline PLM and QMS processes.
- Partner with business stakeholders to gather, analyze, and document business requirements.
- Translate business needs into Oracle Fusion Cloud PLM requirements.