Manager, CE Quality & Regulatory Compliance

1100 Endeavor Health Clinical Operations; Skokie (IL); On-site; USD 81,000 - 126,000; Full time

Benefits offered by this job

Annual increases based on performance

Career pathways for professionalGrowth

Medical, dental, vision options

Tuition reimbursement

Free parking

Wellness program

HSA options

401(k) retirement match

Paid time off and holidays

Community involvement opportunities

Job summary

Endeavor Health is seeking a System-level owner of its Clinical Engineering quality and regulatory program across all nine hospitals. You will oversee the Medical Equipment Management Plan (MEMP), Joint Commission, CMS, and NFPA 99 readiness, the AEM program, recalls, hazard-alert, and cybersecurity programs, delivered through designated program leads.

Leads a team of Clinical Engineers and a CE Data Analyst.

Qualifications

• Bachelor's degree in clinical/biomedical engineering, healthcare administration, or a related field.
• 5+ years in HTM with regulatory/accreditation and recall-management experience; cybersecurity exposure.
• Strong CMMS fluency for compliance reporting and cross-functional coordination.

Responsibilities

• Maintain Joint Commission EC/EM, CMS COP, and NFPA 99 readiness.
• Lead mock surveys, tracers, and corrective actions; govern the AEM program and annual evaluation.
• Ensure 100% PM completion on high-risk and life-support devices.
• Own medical-device recall, hazard-alert, and cybersecurity programs with designated leads.
• Oversee system MEMP updates and audit readiness.
• Lead CE team; set priorities, develop staff, manage performance, and HR responsibilities.
• Define regulatory KPIs and reporting infrastructure.

Skills

Regulatory compliance

Leadership

Cybersecurity awareness

Cross-functional collaboration

Recall management

Education

Bachelors in clinical/biomedical engineering

Tools

CMMS

MDS2 documentation

Job description

Position Highlights

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.

Application Deadline: 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

Job Summary

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.

What you will do

• 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…

What you will need

• 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 MDS2/Medical device cybersecurity documentation

Benefits (For full time or part time positions)

• Opportunity for annual increases based on performance


• Career Pathways to Promote Professional Growth and Development


• Various Medical, Dental, Pet and Vision options


• Tuition Reimbursement


• Free Parking


• Wellness Program


• Savings Plan Health Savings Account Options


• Retirement Options with Company Match


• Paid Time Off and Holiday Pay


• Community Involvement Opportunities

About Endeavor Health

Endeavor Health is a fully integrated healthcare delivery system committed to providing access to quality, vibrant, community-connected care, serving an area of more than 4.2 million residents across six northeast Illinois counties. Our more than 25,000 team members and more than 6,000 physicians aim to deliver transformative patient experiences and expert care close to home across more than 300 ambulatory locations and eight acute care hospitals – Edward (Naperville), Elmhurst, Evanston, Glenbrook (Glenview), Highland Park, Northwest Community (Arlington Heights) Skokie and Swedish (Chicago) – all recognized as Magnet hospitals for nursing excellence.

For more information, visit www.endeavorhealth.org.

When you work for Endeavor Health, you will be part of an organization that encourages its employees to achieve career goals and maximize their professional potential. Please explore our website (www.endeavorhealth.org) to better understand how Endeavor Health delivers on its mission to “help everyone in our communities be their best”. Endeavor Health is committed to working with and providing reasonable accommodation to individuals with disabilities. Please refer to the main career page for more information. At Endeavor Health, we are united by a shared commitment to working together to create a culture of connection and belonging—each of us bringing different skills and experiences as we deliver safe, seamless, and personal care. Every person, every time. We are committed to fostering an environment where all team members can be their best, learn, and pursue excellence together.

EOE: Race/Color/Sex/Sexual Orientation/ Gender Identity/Religion/National Origin/Disability/Vets, VEVRRA Federal Contractor.