• 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.

Requirements Required Qualifications

• 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.

Preferred Qualifications

• 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.

Work Environment & Physical Demands

• 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

Equal Opportunity Employer Phronetik is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Note on Contingent Employment This position is contingent upon contract award. Candidates selected for this role will be expected to confirm their intent to join the company upon successful contract award.

Phronetik, as a small business government contractor, is unable to finalize employment until the contract is officially awarded. This ensures that all hiring aligns with federal requirements and contract needs.