Engineering Change Coordinator

hace 7 días

Tijuana BC, México Sunrise Medical A tiempo completo
y detalle de las actividades

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

Experiencia y requisitos

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.

Beneficios

  • Beneficios de acuerdo a la LFT
  • Seguro de gastos médicos
  • Transporte
  • Uniforme
  • Servicios medicos en planta
  • Comedor

Número de vacantes 1

Área Ingeniería

Contrato Permanente

Modalidad Presencial

Turno Diurno

Jornada Tiempo Completo

Horario

  • Turno Matutino

Estudios Carrera con título profesional

Inglés Hablado: Avanzado, Escrito: Avanzado

Disponibilidad p. viajar No

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