Systems Specialist - PTC Windchill / Change Manager-Hybrid

ELYON International; Bothell (WA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Paid sick leave

Medical/Dental

401(k) Retirement Plan

Employer Paid Life Insurance

Employer Paid Short Term Disability

Optional Life Insurance

Job summary

ELYON International is seeking a Windchill PLM Administrator in Bothell, WA to manage roles, permissions, and security in a regulated environment. You will maintain Windchill objects and containers, ensure data integrity, and support DHF/DMR across projects.

The ideal candidate has 3–5 years of Windchill experience, strong knowledge of design control and change management, and collaborates with Program Management, Engineering, and QA to drive audits, CAPA, and continuous improvement.

Qualifications

• Bachelor's degree (or equivalent) in a related field such as Engineering, Information Systems, or PM.
• 3–5 years of Windchill PLM administration in a regulated environment.
• Strong understanding of design control, document control, and engineering change management.
• Proficiency with Microsoft Office tools.

Responsibilities

• Administer Windchill PLM: manage roles, permissions, and security.
• Maintain Windchill objects: MLOs, CR/CN, PNs, documents, CAD objects, BOMs.
• Maintain Windchill containers: Products, Libraries, Projects.
• Support DHF and DMR creation, maintenance, and audit readiness.
• Ensure documents follow templates with metadata and version control.
• Support audits with traceability reports and CAPA actions.
• Coordinate across multiple offices; collaborate with PMO, Eng, QA.
• Assist in system enhancements, upgrades, validation, and quality processes.

Skills

Windchill administration

Design control

Document control

Change management

Audit readiness

Regulated environment

Data integrity

Cross-functional collaboration

Attention to detail

MS Office

Education

Bachelor's degree in a related field

Tools

Windchill configuration

SAP integration

CAD integrations

Job description

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.