eNSpect Test Engineer

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Baltimore MD US

Public Trust

Job Description:

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.

Primary Responsibilities
– Work with FDA business owner in understanding the business needs and determining appropriate test scenarios to support demonstrating the capability
– Develop test cases and document exceptions based on FDA business and project needs and specific program requirements
– Collaborate with developers and business analysis in ensuring requirements are implemented correctly and meet customers’ expectations
– Ability to identify solution and evaluate solution to complex system problems with mentoring and coaching from more senior team leaders
– Actively participate/lead in the discovery/validation/verification process throughout the development life cycle
– Actively engage/lead in process improvement initiatives

Basic Qualifications
– Basic knowledge with process modeling or data analytics
– Demonstrated understanding of full software development life cycle
– Willingness to learn new techniques such as, 508 testing requirements, regression testing, ability to learn quickly
– Demonstrated good understanding of engineering or math fields
– Excellent verbal and written communication skills, including experience working directly with team members to discuss requirements and objectives
BA/BS degree in CS, IT, Math or related field
– Ability to obtain and maintain a Public Trust security clearance
– US citizen or permanent resident

Preferred Qualifications
• Prior experience with HP ALM and JIRA
• Academic Experience in developing Job Flow, Business Process and Functional Flow diagrams
• Experience with the FDA customer or related customer experience (in a Health systems technology area)

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