PTC Windchill / Change Manager


Opusing One, LLC
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Job Details
Skills
- Change Request Management
- Medical Devices
- Lifecycle Management
- Design Controls
- Windchill
Summary
Job Title-Systems Specialist - PTC Windchill / Change Manager
Job Location-Hybrid-Bothell, WA 98021
Job Duration-6+ Months Contract
Pay Rate: $67 per hour
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
- Dice Id: 10226534
- Position Id: 9021370
- Posted 1 day ago
Company Info
Opusing is a 100% Minority-owned and diversity-certified firm, specializing in Digital Transformation and staffing services. We empower startups, businesses, and corporations to harness the potential of both Technology and Manpower, driving relentless growth and providing seamless workforce solutions. Our team, led by digital native professionals skilled in creative thinking, programming paradigms, and commercial acumen, is committed to one singular goal – the success of our clients.
Headquartered in Boston, USA, we are a rapidly expanding global workforce solutions company. Our core focus is on tailoring our services to address the unique needs of our clients, thereby significantly enhancing their businesses. We offer unparalleled staff augmentation, HR outsourcing, and IT and non-IT staffing services on a global scale.
Since our inception in 2007, we have remained a forward-thinking and trustworthy technology and staffing partner for renowned brands. We've had the privilege of collaborating with Fortune 2000 companies in North America, including the United States, Canada, India, and the UK. For Contract and Fulltime Professional services, Offshore Staffing, and SOW-based project work, we have consistently been the preferred go-to vendor for all our clients.


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