Systems Specialist - PTC Windchill / Change Manager

Integrated Resources, Inc

Bothell, WA

Apply

JOB DETAILS

SKILLS

CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Change Management, Communication Skills, Configuration Management, Continuous Improvement, Control Systems, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Processing, Data Quality, Detail Oriented, Document Change Management, Document Control, Document Management, ERP (Enterprise Resource Planning), Engineering Change Management, External Audit, Information Technology & Information Systems, Internal Audit, Medical Equipment, Metadata, Microsoft Office, Organizational Skills, Problem Solving Skills, Process Improvement, Product Lifecycle Management, Project Engineering, Project/Program Management, Quality Assurance, Regulations, Reporting Skills, Root Cause Analysis, SAP, SAP BusinessObjects, System Integration (SI), Systems Administration/Management, Systems Engineering, Traceability, Windchill PLM Software

LOCATION

Bothell, WA

POSTED

1 day ago

hybrid
Job Title: 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

About the Company

Integrated Resources, Inc

Resume Resources

Free Resume Templates Free Resume Builder