Engineering Change Coordinator

PRINCIPAL JOB DUTIES & RESPONSIBILITIES:

• Manage & continuously improve the Engineering Change Order (ECO) process across global engineering teams.
• Establish, facilitate, and manage a cross-functional Change Control Board (CCB) to review, prioritize, and approve engineering changes.
• Ensure change requests are properly evaluated for technical impact, manufacturability, quality, and regulatory compliance.
• Collaborate with engineering, manufacturing, supply chain, quality, and regulatory teams to ensure timely and coordinated implementation of approved changes.
• Ensure all affected documents, drawings, and Bills of Materials (BOMs) are accurately updated and released in the PLM system.
• Serve as the primary point of contact for status, progress, and communication regarding engineering changes
• Identify and eliminate process bottlenecks to increase change throughput and reduce average cycle time.
• Develop and maintain KPI dashboards that track ECO performance (e.g., cycle time, backlog size, right-first-time rate).
• Support and drive cross-functional continuous improvement initiatives aligned with Sunrise Medical’s operational excellence goals.
• Promote best practices in configuration management, traceability, and documentation integrity.
• Ensure engineering changes comply with ISO 13485, FDA 21 CFR Part 820, and MDR/IVDR requirements.
• Maintain alignment between design documentation, production configurations, and released products throughout the product lifecycle.
• Support audits and regulatory inspections as the subject-matter expert for change control processes
• ECO cycle time (initiation to implementation)
• ECO backlog size and aging
• Right-first-time ECO rate