Biomedical Engineer Clinical Engineer (Patient Safety Expertise)
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Job Location:
Washington, AR - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Overview
Ansible Government Solutions LLC (Ansible) is seekingan 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 VHAs 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.
Ansibleis 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:
- Bachelors 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
- 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 Masters 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.
Required Experience:
Senior IC
Key Skills
- Design Controls
- Calibration
- FDA Regulations
- LabView
- Physiology Knowledge
- Military Experience
- Minitab
- Research Experience
- Medical Imaging
- Research & Development
- Plastics Injection Molding
- Optics
About Company
Encouraged to Matter Ansible solves complex challenges in the fields of national security, healthcare, and government. What We Do Enhancing unique Government missions with technical, operations, business, and administrative expertise. Advancing care through clinical staffing, emer ... View more
