Systems Specialist - PTC Windchill / Change Manager-Hybrid

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.

ELYON International, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.