Patient Safety Expertise Biomedical Engineer / Clinical Engineer

Goldbelt Apex LLC is a data-focused company dedicated to process and quality in healthcare technology. The Patient Safety Expertise Biomedical Engineer / Clinical Engineer supports a comprehensive Healthcare Technology Management program with a primary focus on medical device safety, regulatory compliance, and incident prevention.

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

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, Experience working in or with the Veterans Health Administration (VHA), Understanding of VISN, VA medical center, and HTM/Biomedical Engineering department operations
• Requires to have a strong healthcare/HTM background, and VHA experience
• This position requires some travel, estimated at up to 30 trips per year, typically short duration and spread across the team