The primary responsibility of this position is to support Logistics Management Institute's customer, the United States Army Medical Materiel Development Activity, through advanced development and fielding of military medical equipment, as well as participating in programs which oversee modernization, lifecycle maintenance, and implementation. This position supports the Fort Detrick, MD location (Contractor office within 10 miles of Fort Detrick).
Support Evaluation of Biomedical Equipment
Analyze medical equipment using maintenance data, usage and life cycle data, and military standards.
Provide input through written reports, evaluations, and recommendations with respect to the standard of care at fixed facility hospitals.
Ensure biomedical equipment is in compliance with applicable regulatory requirements (i.e., FDA, ISO, MIL-STD).
Create and evaluate Systems Requirements Documents for purchase criteria within each Request for Offer (RFO) package.
Evaluate RFO packages and conduct down selections for equipment purchases through the Defense Logistics Agency.
Assist and provide methodology for safety testing, repair, and maintenance of biomedical equipment.
Support PMO operations
Participate and actively engage in Integrated Product Teams and Working Groups, and as a chartered member, provide expert advice.
Conduct market analysis to include available products and industries, and understand product market survivability and viability as a crucial component of force-wide fielding.
Review test plans, and results and reports from clinical studies and other testing, to include the review of the final study reports at the end of each phase of a clinical study, and/or lab results from testing facilities.
Assist Product Managers with review of regular Program Objective Memorandum cycles, spend plans, cost estimates, and other cost analysis requirements.
Monitor, track and report on program cost, schedule, and performance.
Write sustainment plans comprised of integrated product support elements for equipment's lifecycle
Bachelor's Degree preferred
Public Trust Clearance; Desired: Secret Clearance
Seven (7) or more total years of experience with biomedical equipment test and repair
Experience managing Integrated Product Teams and other stakeholder engagements, including technical discussions
Experience preparing and delivering documents ranging from technical reviews to acquisition documentation.
Desired: Experience with medical product development, DoD Testing & Evaluation requirements, and regulatory approval processes
Logistics Management Institute