Biomedical Engineer / Clinical Engineer (Patient Safety Expertise)

Overview Ansible Government Solutions, LLC (Ansible) 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. Ansible is a Service-Disabled Veteran-Owned Small Business (SDVOSB) providing Federal customers with solutions in many arenas. Our customers face wide-ranging challenges in the fields of national security, health care, and information technology. To address these challenges, we employ intelligent and committed staff who take care of our customers' success as if it is their own.

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

Qualifications:

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

Preferred Qualifications:

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 All candidates must be able to: 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 All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.