Leidos Baltimore , MD 21203
The Civil Health Operation is seeking a mid-level Systems Engineer to support a program for the FDA in Baltimore, MD.
The Systems for Inspections, Recalls, Compliance Enforcement (SIRCE) and Imports program supports the Food and Drug Administration (FDA) Office of Regulatory Affairs' (ORA) critical work to safeguard the foods, drugs, devices, biologics, and veterinary products that the Agency regulates. These systems continue to evolve to meet emerging business needs and to support new mandates and initiatives. It is important to analyze and implement advances in technologies that will improve efficiency and performance leading to greater user satisfaction and reducing the cost of operations and maintenance (O&M). Effort is underway to develop state of the art applications that can be used on various platforms and to retire some of the legacy systems with modern and efficient applications.
Specific roles & responsibilities for the Systems Engineer position include but not limited to the following:
Work with FDA business owner in understanding the business needs and communicating to a wide range of stakeholders
Analyze, develop and present requirements based on FDA business and project needs
Collaborate with developers, DBAs and testers and drive software development team in ensuring requirements are implemented correctly and meet customers' expectations
Ability to identify, evaluate and demonstrate solutions to complex system problems
Actively participate/lead in the discovery/validation/verification process throughout the development life cycle
Actively engage/lead in process improvement initiatives
Bachelors degree from an accredited college in a related discipline, or equivalent experience/combined education, with 6-8 years or more of professional experience; or 6 years of professional experience with a related Masters degree. Considered an emerging expert, authority in discipline.
Proven experience working in complex projects gathering user requirements and converting them into user story and acceptance criteria requirements
Working knowledge with workflow analysis and process modeling
Demonstrated understanding of full software development life cycle and FDA's EPLC process
Hands on experience with requirements management tool
Proven experience with supporting highly critical customer missions
Demonstrated good understanding of engineering fields
Excellent technical writing, verbal and written communication skills, including experience working directly with customers to discuss their requirements and objectives
Experience with JIRA, HP ALM, Powerpoint, VISIO, SQL Developer
FDA domain knowledge
Familiar with Agile development methodology
US Citizen or US Person (Green Card Holder) with the ability to obtain a Public Trust Clearance is required.
Leidos is a global science and technology solutions leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company's diverse employees support vital missions for government and commercial customers. 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. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an equal opportunity employer/disability/vet.