Clinical Engineer

SUMMARY

Reports to Director of Medical Engineering and is responsible for capital equipment evaluation, selection, planning and installation, integration, interconnectivity of medical devices and systems. Plans and organizes Brown University Health system-wide Medical Equipment Management Plan to ensure patient safety and safe and quality operations of medical devices and meet regulatory agencies requirements.

Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another.

• Instill Trust and Value Differences
• Patient and Community Focus and Collaborate

• Designs and develops processes and methodologies to evaluate state-of-the-art capital equipment. Coordinates the selection, acquisition and installation of new Patient care technology systems.
• Interacts with outside vendors, regulatory agencies and personnel of various levels within and outside of Brown University Health system to provide consultation on performance, technical specifications, clinical applications, evolving compatibility and safety of Medical Devices and systems.
• Develops, standardizes and implements system-wide Medical Equipment Management Plan to ensure safe and quality performance of medical equipment, and meeting the Environment of Care Committee requirements at each Brown University Health affiliate.
• Participates in organizational failure modes and effects analysis as requested in compliance with TJC requirement. Performs technical testing of equipment performance and participates in root cause analysis on equipment failure and incidents in compliance with Safe Medical Device Act (SMDA).
• Continually reviews Medical device systems and components to determine which are technologically obsolete or otherwise no longer adequately supportable and prepare multi-year replacement plans and implements component and Medical device system upgrades in a timely manner.
• Coordinates with various stakeholders a process to standardize, prioritize, develop and implement plans to manage/mitigate risks associated with interconnected integrated Medical device systems by applying appropriate administrative, Physical and technical safeguards.
• Performs Failure Modes and Effectiveness Analysis (FMEA) on Medical devices and systems connected to IT networks to identify points of failure.
• Monitors and adopts industry Best Practices to insure integrity, availability and confidentiality of data maintained and transmitted across interconnected and integrated Medical devices and systems.
• Educates various project stakeholders on implications associated with the proliferation of interconnected and integrated medical device systems and technologies.
• Provides technical oversight and consultation to Medical Engineering and other Clinical/Non-Clinical Staff as required in clinical device systems implementation and integration projects.
• Develops equipment performance improvement standards and corrective action measures to ensure compliance with regulatory standards related to medical devices.
• Ensures that system wide Medical Equipment Maintenance policies, procedures and required records are in compliance with safety codes set out by regulatory agencies such as Food and Drug Administration (FDA), Department of Public Health (DPH), National Fire Protection Association (NFPA), National Electrical Code (NEC), The Joint Commission and manufacturers' requirements.
• Maintains the integrity of FDA Approval for interconnected integrated medical systems including Medical Device Data Systems (MDDS).
• Responsible for the standardization of the Medical Engineering department performance standards, procedures and protocols, maintenance procedures and system-wide problem solving and communication.
• Coordinates the internal and external medical device product recalls and alerts to ensure safe environment for patients, staff and visitors that are part of all Medical Engineering departments system-wide.
• Investigates equipment incidents related to Medical/legal issues and works closely…