General Dynamics Information Technology – Federal Civilian Division is looking for Product Management Support to join our team to support the United States Army Medical Material Development Activity (USAMMDA). This position is based in Ft. Detrick – Frederick, Maryland. The Biomedical System Engineer provides expertise to support of the following tasks in the assigned product in support of the Warfighter Health, Performance and Evacuation (WHPE) Product Management Organization (PMO).
In this role, the ideal candidate would:
Conduct market research on the latest medical devices and technology available or in development within the DoD and commercial industry.
Conduct systems analysis to include data captured and transmitted, data capture methods, FDA certification and compliance, integration potential and method, production feasibility/capability, and operational suitability.
Develop acquisition/product support documentation and strategies for assigned medical devices and equipment.
Support/sustain a medical device Engineering Change Management (ECM) process in order to guide the development and management of requirements-driven medical devices through the entire agile engineering life cycle for assigned medical devices and equipment.
Develop and manage a test program that is consistent and aligns with the Program-wide Test and Evaluation Master Plan (TEMP) for assigned medical devices and equipment.
Compile and document plans, processes, test objectives, test results, and other documentation as required for assigned medical devices and equipment.
Coordinate with required external program offices and commercial vendors, to include but not limited to, Telemedicine Advanced Technology Research Center (TATRC), Medical Communications for Combat Casualty Care (MC4), Combat Casualty Research Program (CCCRP), US Army Institute of Surgical Research (USAISR) and Defense Health Information Management System (DHIMS) to coordinate the development and integration of different medical devices and equipment.
Participate in external engineering design and requirements generation processes with the Army Medical Department Center and School (AMEDD C&S), Health Readiness Center of Excellence (HRCoE), Capability Development Integration Directorate (CDID), and Joint Program Committees (JPC) 1-6 for assigned medical devices and equipment, as required.
Conduct internal design project requirements analysis for assigned medical devices and equipment to derive lower level requirements and system specifications with traceability from system specifications, through lower-level requirements, to the end user requirements represented in published requirements documents.
Provide direct support of uniformed soldiers during test, evaluation, training exercises and warfighter assessments. This includes all levels of review and oversight of assigned medical devices and equipment on the ground and air platforms.
Rapidly learn the DoD Acquisition processes to support the DoD Acquisition Lifecycle and develop required engineering acquisition documents for multiple medical devices in development at the product management office.
Bachelors of Science degree in Biomedical or Systems Engineering, or the equivalent combination of education, professional training, or work experience.
2+ years of related experience. At least 1 years' experience as a product manager or product life cycle management.
Excellent oral and written communications skills required.
Moderate Travel is required (10-25%) throughout CONUS and potentially OCONUS.
Must be a U.S. citizen
Must be NACI(T1) clearable
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.