About The Position

[FIRM] is seeking an experienced Biomedical Engineer/Clinical Engineer specializing in patient safety to manage medical device recall and alert programs, conduct incident investigations, and develop preventive strategies across VHA's 170+ medical centers. You will provide technical expertise for adverse events involving medical equipment, coordinate risk assessments, and communicate safety concerns to field programs and regulatory bodies to ensure compliance with patient safety goals, FDA SMDA, and TJC requirements.

Requirements

  • Bachelor's degree or higher in Engineering OR Certification as a Clinical Engineer (CCE) required
  • Ability to obtain Public Trust Clearance (Tier 1/NACI). U.S. Citizenship required
  • 5+ years of demonstrated competency managing recall and safety alert programs for medical devices
  • Experience with medical device hazard investigations and regulatory compliance (SMDA, TJC, patient safety goals)
  • Knowledge of computer-based medical systems, networking protocols, and medical equipment management programs

Nice To Haves

  • Experience within a medical center HTM/Biomedical Engineering department, OR experience working in or with the VHA, OR understanding of VISN, VA medical center, and HTM/BE operations
  • CCE certification, Master's degree in Biomedical/Clinical Engineering, or FDA MAUDE database experience

Responsibilities

  • Coordinate and conduct medical device patient safety incident investigations and develop enterprise-wide corrective actions
  • Manage medical device recall and alert programs including risk assessment, field coordination, and compliance tracking
  • Support and optimize enterprise recall management workflows to ensure consistent, system-wide execution
  • Provide technical analysis for adverse events involving medical equipment and prepare executive-level safety reports
  • Communicate safety concerns and mitigation strategies to field HTM programs, VA leadership, and industry partners
  • Interface with FDA, manufacturers, and regulatory bodies on safety matters and maintain recall tracking systems
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