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Solutions Architect (Information Technology Specialist)

The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.

The mission of Center for Devices and Radiological Health (CDRH or Center) is to protect and promote the public health by performing essential public health tasks by making sure that medical devices and radiological health products are safe for people in the United States. Within CDRH, the Office of Strategic Partnerships and Technology Innovation (OST) provides leadership for all scientific collaborative and emerging technology related activities at CDRH. The Division of Technology and Data Services (DTDS) within OST directs and oversees the Center's data, technology, and transformation services to ensure effective design, integration, and utilization of information systems, electronic data, and analytic capabilities to optimize regulatory business processes.

The Solutions Architect will report to the Assistant Director for Technology Services in the DTDS and will directly support the Center’s Digital Transformation Initiative. As such, the incumbent will be responsible for evaluating current business practices and understanding future business requirements, mapping new core business processes and elements to agreed upon technical requirements, and developing and implementing effective scalable software solutions to ensure an effective, efficient and seamless integration and transformation. In this critical role, the Solutions Architect will collaborate with key stakeholders to forge and implement a strategic vision to design and develop sustainable solutions to complex business and integration concerns with a rich variety of technologies and a mixture of agile and planned methods. This individual also serves as a technical lead on the IT initiatives and projects that involve the development, modernization, and enhancement or the operations and maintenance of the Center’s IT systems.

The Solution Architect will perform the following:
  • Serve as a technical authority on systems architecture principles and development methodologies (including Agile, Iterative, etc.).
  • Create, implement, and lead the process of integrating systems and utilizing software to meet the Centers complex business needs.
  • Provide expert guidance and offers recommendations to Office and Center leadership on highly complex architecture situations.
  • Apply in-depth functional and technical knowledge of Cloud-based solutions, commercial-off-the-shelf (COTS) software, and custom development (e.g., Java). 
  • Perform thorough analyses on applying technologies to needed enterprise capabilities and prepares recommendations for leadership outlining technical solution alternatives, including risks, benefits, business impact, and costs.  
  • Develop implementation and integration plans for IT project priorities and objectives in migrating from legacy IT systems to more efficient IT solutions that will positively impact the Center.
  • Lead and execute all technical activities throughout all phases of the system development lifecycle and ensures the integration of all systems components, e.g., procedures, databases, policies, software, and hardware.
  • Continuously assess the Center’s business needs and researches new and emerging technologies and innovative solutions to support updates and modifications to existing architecture in a changing environment.

To qualify for this position, you must demonstrate in your resume the necessary qualifying experience for this position, which is equivalent to the following:
  • Ability to install or support the installation of vendor software and tools in data centers.
  • Expertise in implementing Cloud-based solutions, including Software as a Service (SaaS), Platform as a Service (PaaS) and Infrastructure as a Service (IaaS)
  • Ability to lead and manage all technical activities in the development, implementation, operation, and maintenance of the Center’s IT systems, which includes multiple, interdependent technology and data projects.
  • A solution-focused professional, with expert project management and highly effective communication skills, who can successfully manage all aspect of solution development and share information in plain language with stakeholders, software vendors, solutions development teams, and contractors. 
  • Wide-ranging technical expertise in solution design and development with business modeling and logic integration 
  • Wealth of experience in business analytics, Big Data, IT infrastructure, DevOps, and cybersecurity

Desired Skill Set
  • Prior experience in a scientific, regulatory, and/or clinical setting is preferred.  
  • Ability to work collaboratively with a diverse cadre of customers and stakeholders in a continuous quality improvement environment.
  • Excellent oral and written communication skills.
  • Ability to manage projects and work effectively within teams.

How to Apply
Submit electronic resume or curriculum vitae and unofficial transcripts to with the subject line: OST, DTDS Solutions Architect. Applications must be received by March 16, 2021