System Specialist

We are looking for an experienced Systems Specialist – PTC Windchill / Change Management to support Product Lifecycle Management (PLM) operations in a highly regulated environment. The ideal candidate will have hands-on experience administering PTC Windchill, managing engineering change processes, document control, and supporting quality and compliance initiatives within cross-functional teams.

Key Responsibilities:

• Administer and maintain PTC Windchill PLM in a regulated environment.
• Manage user roles, permissions, security, and access controls.
• Support engineering change management, including Change Requests (CR), Change Notices (CN), Problem Reports, and controlled documentation.
• Maintain product structures, parts, CAD objects, and PLM containers.
• Support Design History File (DHF) and Device Master Record (DMR) management, ensuring complete traceability and compliance.
• Ensure controlled documents follow approved templates, metadata requirements, version control, and release procedures.
• Assist with internal and external audits by providing PLM documentation, traceability reports, and CAPA support.
• Collaborate with Engineering, Quality, Project Management, and other cross-functional teams.
• Support Windchill system enhancements, upgrades, validation, and continuous process improvement initiatives.
• Facilitate communication between centralized PMO and distributed project teams.

Required Qualifications:

• Bachelor's degree in Engineering, Information Systems, Project Management, Computer Science, IT, or a related field.
• 3–5 years of experience supporting or administering PTC Windchill PLM in a regulated industry.
• Strong knowledge of:
• Design Control
• Engineering Change Management (ECN/ECO)
• Document Control
• Configuration Management
• Experience with Microsoft Office Suite.
• Excellent communication, coordination, and organizational skills.

Preferred Qualifications:

• Experience in the Medical Device, Life Sciences, or other regulated industries.
• Knowledge of DHF, DMR, and Master List Objects (MLOs).
• Experience with Windchill workflows, lifecycle management, and system configuration.
• Familiarity with SAP/ERP integrations and CAD integrations.
• Experience supporting audits, regulatory inspections, and compliance activities.