Clinical Engineer

SUMMARY

Assists department director with all aspects of program management, including work history data analysis, staffing allocation, budget control, equipment acquisition planning, installation and testing, outside vendor management, development of policies and procedures, and provision of Healthcare Technology Management services. Ensure all program components support accreditation and other state and local codes related to electrical and mechanical equipment safety. Perform rounds on clinical units to verify proper equipment use and operation. Develop and monitor compliance with equipment preventive maintenance schedules. This role is pivotal in ensuring the highest standards of quality, safety, and regulatory adherence related to medical devices and equipment used within our healthcare facility. The successful candidate will collaborate with cross-functional teams to oversee quality management systems, maintain regulatory compliance, and optimize processes to enhance patient care and safety.

BENEFITS
UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100% coverage for preventive healthcare-no copay
• Paid Time Off, available day one
• Retirement Programs through the Teacher Retirement System of Texas (TRS)
• Paid Parental Leave Benefit
• Wellness programs
• Tuition Reimbursement
• Public Service Loan Forgiveness (PSLF) Qualified Employer

EXPERIENCE AND EDUCATION

Required

• Education
  Bachelor’s Degree in Biomedical Engineering, Electrical Engineering, or a related field
• Experience
  3 years of hospital experience in Healthcare Technology Management, Clinical or Biomedical Engineering
• Licenses and Certifications
  Certified Clinical Engineer (CCE) 2 Years or
  (CHTM) CERT HLTHCR TECHNOLOGY MANAGER 2 Years and
  (DRIVERS) DRIVERS LICENSE – Must have valid State of Texas Driver’s License Upon Hire

Preferred

• Education
  Master’s Degree or equivalent experience preferred

JOB DUTIES

• Develop, implement, and oversee quality management systems (QMS) for medical devices and equipment, ensuring compliance with regulatory standards such as FDA regulations, AAMI, ISO, and other relevant guidelines.
• Conduct audits and inspections to assess compliance with regulatory requirements, identifying areas for improvement and implementing corrective actions as needed.
• Collaborate with various departments to establish and maintain standard operating procedures (SOPs) related to the procurement, usage, maintenance, and disposal of medical equipment.
• Provide guidance and support in the selection, evaluation, and validation of new medical devices, ensuring they meet quality and regulatory standards.
• Lead or participate in risk management activities related to medical devices, including hazard analysis, risk assessments, and mitigation strategies.
• Serve as a subject matter expert on quality and regulatory matters, providing training and guidance to hospital staff to ensure understanding and adherence to standards and procedures.
• Maintain up-to-date knowledge of changes in regulations and standards affecting medical devices, and implement necessary changes to ensure ongoing compliance.
• Collaborate with research teams to ensure that research projects involving medical devices comply with regulatory requirements and ethical standards.
• Actively participate in AAMI standards development.
• Performs other duties as assigned.

SECURITY AND EEO STATEMENT

Security
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.

EEO
UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.