Patient Safety Expertise Biomedical Engineer / Clinical Engineer

Goldbelt, Inc.•De Leon Springs, FL

1d•Remote

About The Position

This position supports a comprehensive Healthcare Technology Management (HTM) program with a primary focus on medical device safety, regulatory compliance, and incident prevention. The role provides technical expertise in medical equipment performance, device-related risk mitigation, and the management of recalls, safety alerts, and hazard investigations. The position is primarily remote with some travel involved, up to 30 short-duration trips per year. The Veterans Health Administration (VHA) National Healthcare Technology Management (HTM) Program Office is headquartered at the VA Boston Healthcare System campus in Bedford, Massachusetts, with additional major centralized program offices and strategic support located in Washington, D.C., and Severna Park, Maryland. This position is contingent upon the successful award of a contract currently under bid.

Requirements

Demonstrated skill in communicating and working collaboratively with key stakeholders, including technical and professional staff at various levels of a healthcare organization.
Knowledge of concepts related to computer based medical systems, networking protocols, and information security as it applies to medical technology.
Competency in conducting a medical equipment management program that is compliant with applicable healthcare standards and regulatory agencies.
Ability to manage a recall and safety alert program for medical devices, including medical device hazard investigations, to assure compliance with patient safety goals, SMDA, and TJC requirements.
Understanding of regulatory agencies’ requirements, industry regulatory requirements and International Standard Organization standards.
Bachelor’s degree or higher (or CCE certification)
Minimum 5+ years of experience and demonstrated competency to manage a recall and safety alert program for medical devices, including medical device hazard investigations, to assure compliance with patient safety goals, SMDA, and TJC requirements.
Shall meet at least one of the following basic qualifications: Experience within a medical center and Healthcare Technology Management (HTM)/ Biomedical Engineering department OR Experience working in or with the Veterans Health Administration (VHA) OR Understanding of VISN, VA medical center, and HTM/Biomedical Engineering department operations
Requires to have a strong healthcare/HTM background, and VHA experience

Responsibilities

Manage and maintain a compliant medical device recall and safety alert program, ensuring timely investigation, documentation, and resolution in alignment with SMDA, TJC, and patient-safety requirements.
Conduct medical device hazard investigations and support incident reviews, providing technical analysis and recommendations to prevent recurrence and improve system-wide safety.
Support the medical equipment management program by ensuring adherence to regulatory, accreditation, and industry standards, including ISO and applicable healthcare requirements.
Provide technical expertise on computer-based medical systems, device networking, interoperability, and information security considerations.
Collaborate with clinical staff, HTM teams, and leadership to address medical device issues, improve safety processes, and strengthen organizational compliance.