Ansible Government Solutions · 2 days ago
Biomedical Engineer / Clinical Engineer (Patient Safety Expertise)
Ansible Government Solutions is seeking an experienced Biomedical Engineer/Clinical Engineer specializing in patient safety to manage medical device recall and alert programs. The role involves conducting incident investigations and developing preventive strategies across VHA's medical centers while ensuring compliance with patient safety goals and regulatory requirements.
ConsultingService IndustrySmall and Medium Businesses
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
Qualification
Required
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
Sit, stand, walk, lift, squat, bend, twist, and reach above shoulders during the work shift
Lift up to 50 lbs from floor to waist
Lift up to 20 lbs
Carry up to 40 lbs a reasonable distance
Push/pull with 30 lbs of force
Preferred
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