The Government Health and Safety Operation is seeking a Product Lead 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 Product Lead 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
- Work with other product leads and teams to collaboratively identify dependencies, develop plans and mitigate risks
- Lead analysis, development and presentation of requirements, design approaches and implemented solutions
- Lead team of business analysts, developers, DBAs and testers in a scrum/agile environment and drive software development team in ensuring requirements are implemented correctly and solutions meet customers' expectations
- Ability to think critically and strategically to identify, evaluate and demonstrate solutions to complex system problems
- Actively lead the discovery/validation/verification process throughout the development life cycle
- Actively engage/lead in process improvement initiatives
Bachelor's degree from an accredited college in a related discipline, or equivalent experience/combined education, with 12 years or more of professional experience; or 8 years of professional experience with a related Master's degree. Considered an expert, authority in discipline.
- Proven experience working in large, complex projects and integrated product teams
- Experience leading development (DME) projects
- Working knowledge with workflow analysis and process modeling
- Demonstrated understanding of full software development life cycle
- Proven experience with EPLC
- Demonstrated understanding and experience with transforming an agile project
- Hands on experience with team leadership and execution
- Proven experience with supporting highly critical customer missions
- Demonstrated good understanding of engineering fields
Excellent verbal and written communication skills, including experience working directly with customers to discuss their requirements and objectives
Experience with JIRA, HP ALM, Powerpoint, VISIO
Experience leading application development teams using Java, Angular technology stack
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.