- Word Processing
- Anatomy Knowledge
- FDA Regulations
- Communication Skills
- Physiology Knowledge
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 Lifespan system-wide Medical Equipment Management Plan to ensure patient safety and safe and quality operations of medical devices and meet regulatory agencies requirements.
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 Lifespan 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 Lifespan 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 with Risk Management and the Legal Department within the hospital.
Manage and Plan the Wireless Radio Frequency spectrum in the hospital environment to reduce the risk of Electro Magnetic Interference (EMI) and ensure safe performance of the Wireless Medical devices.
Manages the computerized medical equipment management system. Maintains a very detailed and current inventory of networked and integrated medical systems including catalogue of services features and interconnections. Streamlines the equipment database to ensure it is up to date from a regulatory standards point of view.
Works with the Medical Equipment Management database vendor to improve user interfaces resolve programming issues create custom interfaces (forms reports etc.) to improve database functionality and reflect the changes in staff/departmental processes.
Participates in performance improvement initiatives and demonstrates the use of Engineering principles and analytical concepts for quality improvement in daily operations
Trains/Mentors Clinical Non-Clinical and Medical Engineering staff in the safe and effective performance and service of complex Medical devices and systems.
Other information:BASIC KNOWLEDGE:
A Masters Degree in Biomedical Engineering with Clinical Engineering concentration (track) or a Masters Degree in Biomedical Engineering and 2 years of prior work experience as a Clinical Engineer in a healthcare setting.
Experience in a healthcare environment or as gained through a hospital based internship program as needed for the degrees noted above.
If qualifying based on prior work experience knowledge of medical device systems and technologies used in a healthcare environment which includes principles of operation major features device networking methods for testing and evaluating each technology available in the market. This includes a required knowledge of human physiology and anatomy which relates to understanding the engineering principles in the application of clinical devices and technologies in complex medical devices which may include and are not limited to Diagnostic and Therapeutic radiology equipment automated lab equipment central patient monitoring systems anesthesia machines surgical lasers microscopes video systems and integration is required.
Knowledge of codes and standards of FDA Joint Commission and other regulatory organizations governing the technology management in a health care environment.
Knowledge of database programming languages including Microsoft SQL and Access; XML HTML and VB. Must be proficient in personal computer applications including word processing and spreadsheets as well as technical drawing software including Microsoft Project and Visio.
Strong communication and team building skills with leadership qualities.
Proven ability to work collaboratively within a multidisciplinary consulting team environment as this position will lead interdisciplinary teams and manage complex projects.
WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS:
Exposed to normal patient care environment with frequent standing and walking.
Lifespan is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race color religion sex national origin age ethnicity sexual orientation ancestry genetics gender identity or expression disability protected veteran or marital status. Lifespan is a VEVRAA Federal Contractor.
Location: Rhode Island Hospital USA: RI: Providence
Work Type: Full Time