Biomedical Engineer
- Manage and oversee medical device recall programs and safety alert systems, ensuring compliance with patient safety goals, Safe Medical Device Act (SMDA), and The Joint Commission (TJC) standards.
- Conduct medical device hazard investigations, evaluate risk, and implement corrective actions across VHA facilities.
- Develop and maintain policies, procedures, and documentation to support patient safety initiatives, incident investigations, and safety compliance reporting.
- Collaborate with field-based HTM personnel, clinical staff, and executive leadership to communicate safety guidance, escalate critical risks, and ensure timely resolution of safety issues.
- Support biomedical equipment management programs to ensure alignment with healthcare standards, federal regulations, and regulatory agency requirements.
- Provide expertise on computer-based medical systems, networking protocols, and medical device cybersecurity, ensuring that safety practices incorporate technology and security considerations.
- Maintain awareness of emerging medical device technologies and regulatory changes that could impact patient safety and biomedical equipment operations.
- Assist in preparing reports, briefings, and recommendations for program leadership regarding patient safety initiatives, recalls, and hazard investigations.
- Contribute to the development of training materials and educational resources to enhance patient safety practices across HTM programs.
- Bachelor’s degree or higher in Engineering or related field.
- Minimum of 5 years of experience in biomedical engineering, clinical engineering, or healthcare technology management with a focus on patient safety.
- Demonstrated competency in managing medical device recall programs, safety alerts, and hazard investigations.
- Strong ability to communicate and collaborate with technical, clinical, and administrative staff at multiple levels.
- Knowledge of computer-based medical systems, networking protocols, and cybersecurity as applied to medical technology.
- Experience conducting medical equipment management programs compliant with healthcare standards, federal regulations, and regulatory agency requirements.
- Understanding of regulatory requirements, including FDA, SMDA, TJC, ISO, and other relevant standards.
- Experience within VA or federal healthcare environments.
- Certification as a Clinical Engineer (CCE)
- Prior involvement in telehealth or networked medical device programs.
- Familiarity with HTM program office processes, VISN operations, and field HTM program assessments.
- VA facilities, Phronetik facilities, with optional remote work; travel to VA sites may be required.
- Must comply with federal regulations and VA policies.
- Standard office and clinical environment
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