The Civil Health Operation is seeking a Senior Business Analyst/Systems Engineer to support a program for the FDA in Baltimore/Rockville, 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:
Provide overall leadership to the FDA Systems Engineer/Business Analyst team
Actively engage/lead in process improvement initiatives
- Lead FDA business owner in understanding the business needs and communicating to a wide range of stakeholders
- Lead analysis, development and presentation of 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
Bachelors degree from an accredited college in a related discipline, or equivalent experience/combined education, with 14 years or more of professional experience; or 12 years of professional experience with a related Masters degree. Considered an expert, authority in discipline.
- Proven experience working in complex projects gathering user requirements and converting them into user story and acceptance criteria requirements
- Proven experience 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.
External Referral Bonus:
Potential for Telework:
Clearance Level Required:
Scheduled Weekly Hours:
Business Systems Analysis