Manager, CE Quality & Regulatory Compliance

Hourly Pay Range: $59.05 - $91.53 - The hourly pay rate offered is determined by a candidate's expertise and years of experience, among other factors.

Final date to receive applications:
To be considered, please apply by the end of day on Wednesday, November 11th.

Position:
Manager, Clinical Engineering Quality & Regulatory Compliance

Multiple Locations Available:
Skokie, Corporate – Systemwide Coverage

Full Time/Part Time:
Full time

Hours:

Days;
Regular hours of operation

System-level owner of Endeavor Health's Clinical Engineering quality and regulatory program across all nine hospitals. Accountable for the Medical Equipment Management Plan (MEMP); continuous Joint Commission, CMS, and NFPA 99 readiness; the Alternative Equipment Maintenance (AEM) program; medical-device recall; hazard-alert; and cybersecurity programs, delivered through designated Clinical Engineer program leads. Leads a team of Clinical Engineers and the CE Data Analyst.

Partners with Information Security, Supply Chain, and clinical leadership to keep the medical-device fleet safe, compliant, and survey-ready.

• Maintain continuous Joint Commission EC/EM, CMS Conditions of Participation, and NFPA 99 readiness;
• lead mock surveys, tracers, real-survey response, and PFI remediation Govern the Alternative Equipment Maintenance (AEM) program — inclusion criteria, risk scoring, exclusion of high-risk and life-support equipment, and the annual AEM evaluation;
• ensure 100% PM completion on high-risk and life-support devices
• Own the medical-device recall and hazard-alert program (FDA, ECRI, manufacturer) — direct the designated Clinical Engineer lead who executes intake, affected-asset identification via the CMMS, clinical notification, dispositioning, and closure documentation
• Own the medical-device cybersecurity program — accountable for CE's response to security incidents on connected devices, directing the designated Clinical Engineer lead and coordinating containment and remediation with Information Security; oversee vulnerability and patch tracking and MDS2 review at procurement
• Own and annually update the system Medical Equipment Management Plan (MEMP); ensure each site's program conforms and is audit-ready
• Lead the Clinical Engineers and CE Data Analyst — set program priorities, develop staff, manage performance, and integrate their work across the quality, regulatory, CMMS, and analytics programs; perform full HR responsibilities for the team
• Define regulatory KPIs and their targets — PM completion by risk class, overdue work orders, life-support compliance, recall closure, patch status; the CE Data Analyst builds and maintain the reporting infrastructure…

• Education:
  
  Required:
  
  Bachelor's degree in clinical/biomedical engineering, healthcare administration, or a related field.
• Experience:
  
  Required:
  
  5+ years in HTM with demonstrated regulatory/accreditation and recall-management experience; working exposure to medical-device cybersecurity (incident response, vulnerability and patch management). 2+ years leading staff or programs.
• Unique or Preferred
  
  Skills:
  
  Knowledge:
  Deep working knowledge of TJC, CMS Conditions of Participation, NFPA 99, and AEM frameworks; familiarity with medical-device cybersecurity standards (FDA pre/postmarket guidance, IEC 80001, MDS2).
  
  Skills:
  
  Strong CMMS fluency for compliance reporting; excellent written communication; cross-functional coordination across Accreditation, Safety/EOC, Information Security, and clinical teams. Abilities:
  Able to maintain continuous survey readiness; able to translate regulatory and cybersecurity requirements into actionable program controls and KPIs. Technical: CMMS compliance reporting AEM risk scoring models…