Engineering Systems Coordinator - ECN & DCC Ops

Job title:

Engineering Systems Coordinator

Location:

Ocala, Florida

Terms:

Full time

Salary/rate:
Negotiable

Requirements:
See responsibilities section

From the very beginning, Champion has been 100% focused on medical seating. We pride ourselves in being at the forefront of the industry to provide our customers with innovative, clinically effective solutions that improve performance for both patients and caregivers. We continue to set the standard for medical seating, and partner with healthcare organizations to support the industry’s transformation into an all-inclusive, human‑centric experience.

We are seeking a technically minded and process oriented Engineering Systems Coordinator to join our team at Champion Healthcare Solutions, a leader in the design and production of Class 1 medical devices. This role supports engineering operations through administration, optimization, and automation of Engineering Change Notice (ECN), Documents Change Control (DCC), deviation, Product Data Management (PDM), D365, and engineering workflow systems.

The ideal candidate will combine strong organizational skills with technical aptitude to improve engineering process visibility, traceability, and efficiency within a regulated medical device environment. This position will support engineering through workflow coordination, dashboard/report development, automation initiatives, data management and PDM administration. The role does not create product designs or CAD models but plays a critical role in maintaining engineering operational infrastructure and supporting continuous improvement initiatives across engineering systems and processes.

• Manage the end‑to‑end ECN process, including creation, review, tracking, implementation monitoring and closure of ECNs for medical recliner designs, ensuring compliance with applicable quality system requirements and 21 CFR Part 820 where applicable.
• Track and monitor the status of every ECN, visibility of each change’s stage, owner, and required actions.
• Track and report deviation status, aging, and closure requirements, ensuring deviations do not exceed approved timelines.
• Ensure ECN and deviation changes are fully implemented in the Device History Record (DHR) and production documentation before closure.
• Assign due dates and priorities to ECNs and deviations, escalating overdue items to leadership when required.
• Lead weekly ECN review meetings, provide status updates, identify bottlenecks, and align departments on required actions.
• Administration of engineering workflow routing logic.
• Maintain and update Smartsheet, Kanban board, and engineering workflow systems so that ECN progress, aging and department ownership are clearly visualized.
• Ensure ECNs flow smoothly through all required departments, proactively following up with owners to prevent delays or stagnant approvals or implementation gaps.
• Ownership of Power
  
  BI engineering Dashboards.
• Publish weekly ECN dashboards and reports summarizing cycle time, backlog, process health, and critical issues requiring leadership attention using tools such as Excel, Smartsheets or Power
  
  BI.
• Coordinate Document Change Control (DCC) processes, ensuring all design and manufacturing documentation (e.g., DHF, DMR) is updated to reflect ECN changes.
• Process and document deviation paperwork, ensuring deviations are properly recorded, justified, and linked to corrective actions or ECNs.
• Maintain an organized ECN log and traceability matrix using Microsoft Excel, Smartsheet, Power BI or other management software linking ECNs to affected Design History File (DHF) and Device Master Record (DMR) components.
• Create and manage a DHF index to catalog design documents, ensuring quick retrieval for FDA audits (physical and electronic records in PDM or Windows Explorer).
• Review ECN and deviation documentation for completeness, including descriptions, impact assessments, verification/validation results, and approvals.
• Collaborate with engineering and quality teams to ensure ECNs and deviations are implemented in production and reflected in Device History Records (DHRs).
• Support audit preparation by organizing physical and electronic records,…