Engineering Systems Coordinator

Champion Healthcare Solutions•Ocala, FL

just now•Onsite

About The Position

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.

Requirements

Proficiency in Microsoft Excel, Power Query and PowerBI including formulas, pivot tables, dashboards, queries, traceability matrices and engineering or operational data organization.
Experience managing ECN’s DCCs deviations workflow systems or engineering processes in a manufacturing or engineering environment preferred
Experience using document control, workflow, or engineering systems (Smartsheet, D365, PDM systems)
Ability to track engineering workflow status across multiple systems ensuring real time visibility, ownership and process accuracy.
Ability to track and report workflow aging status, KPIs and required actions to support timely closure of engineering processes.
Strong working knowledge of Microsoft Suite (Word, Outlook, PowerPoint) for documentation, communication, reporting and engineering workflow support.
Ability to design, manage, and optimize Smartsheet, Excel, PowerBi and SQL based trackers, automated workflows, and alerts.
Ability to create dashboards and data summaries in Excel, Smartsheet, Power BI for ECN aging, cycle time and departmental throughput.
Understanding how ECNs, DCCs, and deviations affect DHF, DMR and DHR records within the QMS.
Strong organizational and follow up skills to maintain continuous flow of ECNs through the QMS approval pipeline
Capability to identify ECN and overall process bottlenecks and recommend corrective actions or workflow improvements.
Ability to revise and maintain engineering procedures, workflows, SOPs, dashboards, and supporting work instructions as system and processes evolve.
Understanding of Product Data Management (PDM) systems or document management tools (e.g., Smartsheet, Windows Explorer).
Exceptional organizational skills with a proven ability to manage physical and electronic records.
Detail-oriented with the ability to review documents for accuracy and compliance (e.g., signatures, dates, traceability).
Strong collaboration and communication skills to work with engineering, quality, and manufacturing teams.
Ability to prioritize tasks and meet deadlines in a fast-paced environment.
Friendly, team-oriented attitude with a proactive approach to problem-solving and process improvem

Nice To Haves

Bachelor’s degree in computer science, Information systems, Engineering Technology Data Analytics or related technical field preferred.
0-3 years of experience in engineering operations, workflow system, document control, manufacturing support, data analytics, software automation, or related technical environments preferred.
Equivalent experience in engineering operation workflow systems document control manufacturing automation or process improvement may be considered.
Experience facilitating or supporting cross functional meetings, including preparing agendas, tracking action items, and coordinating follow up activities preferred.
Familiarity with FDA regulations (e.g., 21 CFR Part 820) and audit preparation is a plus.

Responsibilities

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 PowerBI 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 PowerBI.
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, testing document retrieval, and ensuring traceability of changes.
Use Microsoft Word to draft and update process documentation, memos, and reports related to ECNs, DCC, Work instructions or Standard operating procedures.
Partner with Document Control to ensure revisions are released correctly and obsolete documents are removed from production use.
Train new users on ECN, DCC, deviation, workflow, dashboard and engineering systems processes, including Smartsheet workflows, Power BI queries, routing rules and documentation expectations.
Support development and maintenance of engineering workflow automation solutions utilizing tools such as power automate, CRUD development, web apps or related technologies.
Assist in development and administration of engineering request intake systems, ticketing systems, workflow routing tools and process tracking solutions.
Support engineering related workflows item management BOM structures, reporting and data integrity activities within D365 and associated business systems
Identify repetitive administrative or engineering workflow tasks and recommend or implement automation and continuous improvement initiatives.