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Engineering Change Coordinator
hace 5 horas
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 Education: Advanced spoken and written English Bachelor’s degree in Engineering, Engineering Technology, or related technical field required. Experience: 3–7 years of experience in an engineering operation, configuration management, or document control role within a regulated manufacturing environment Experience managing or coordinating engineering change processes within a Product Lifecycle Management (PLM) system (e.g., Windchill, Agile, Arena, or Team center). Demonstrated success in improving change management processes or implementing control board governance. Skills & Competencies: Strong organizational and prioritization skills; able to manage multiple concurrent requests. Excellent cross-functional communication and facilitation skills. Data-driven mindset with proficiency in Excel, Power BI, or similar tools for KPI reporting. Understanding of mechanical and electro-mechanical product documentation, BOM structures, and configuration management principles. Familiarity with ISO 13485, FDA QSR, or EU MDR quality systems and documentation practices preferred. #J-18808-Ljbffr