Systems Specialist - PTC Windchill / 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