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
Benefits:
Paid sick leave, Medical/Dental (optional), 401 (k) Retirement Plan (optional), Employer Paid Life Insurance, Employer Paid Short Term Disability, Optional Life Insurance.
