PLM Change Manager

Job Responsibilities:

• Windchill PLM Administration (Regulated Environment): Manage user roles, permissions, and security to ensure proper data access and segregation of duties.
• Administer and maintain Windchill business objects, including:
  • Master List Objects (MLOs)
  • Change Requests (CR), Change Notices (CN), and Problem Reports
  • Controlled documents (design documents, specifications, procedures)
  • CAD-related objects
  • Parts (EBOM/MBOM structures)
• Maintain Windchill containers (Products, Libraries, Projects).
• Support creation, maintenance, and audit readiness of:
  • Design History File (DHF) within Windchill (ensuring completeness, traceability, and proper structure).
  • Device Master Record (DMR) by maintaining controlled product definitions, specifications, and released records.
• Ensure all controlled documents: Follow approved templates, include required metadata (classification, ownership, approvals), and are version-controlled and properly released.
• Support internal and external audits by: Providing traceability reports (MLO/DHF/DMR), demonstrating control over Windchill processes and data, and addressing audit findings and supporting corrective/preventive actions (CAPA) related to PLM processes.
• Multi-Office Coordination: Serve as part of a centralized PSO function supporting multiple geographic or functional offices.
• Collaborate with Program/Project Management, Engineering, Quality Assurance, and other relevant internal stakeholders.
• Support system enhancements, upgrades, and validation activities.
• Participate in continuous improvement initiatives for PLM processes and quality system integration.
• Facilitate communication between central PMO and local project teams.

Required Qualifications:

• Education: Bachelor''s degree (or equivalent experience) in Project Management, Engineering, Information Systems, or a related field.
• Experience: 3-5 years of experience administering or supporting Windchill PLM in a regulated environment. Experience supporting cross-functional teams in a quality-driven environment.
• Required Knowledge: Strong understanding of design control processes, document control systems, and engineering change management.
• Technical Skills: Proficiency with Microsoft Office tools.

Preferred Qualifications:

• Experience in the medical device or highly regulated industry.
• Experience supporting MLO/DHF/DMR structures in PLM systems.
• Knowledge of Windchill configuration, workflows, and lifecycle management.
• Experience with PLM-ERP integrations (e.g., SAP) and CAD integrations.
• Background in audit support and regulatory inspections.

Key Skills & Competencies:

• Windchill PLM administration in a regulated environment
• Design control and configuration management
• Data integrity and compliance (ALCOA+ principles)
• Document control and change management
• Audit readiness and regulatory support
• Strong attention to detail and data accuracy
• Strong organizational and coordination skills
• Cross-functional communication and stakeholder management
• Problem-solving and root cause analysis
• Process-oriented mindset with continuous improvement focus
• Process documentation and training delivery