Jobs in the Digital Health Center of Excellence
Seeking Software Engineers, Data Scientists, Clinicians
At the FDA, we are building a dynamic Digital Health Center of Excellence team whose mission is to protect and advance public health by helping to speed innovations that provide our nation with safe and effective digital health technologies. We are seeking candidates for multiple positions with a variety of expertise in delivering digital health technologies.
The FDA seeks software engineers, artificial intelligence and machine learning engineers, security researchers, user interface and user experience designers, and product managers to be a part of the Division of Digital Health.
The FDA is a great place to work. The FDA offers great employee benefits, and we promote healthy work/life balance with flexible scheduling and telework as well as many on-campus amenities including a childcare center, a free fitness facility with a variety of classes, and more. The FDA's location in Montgomery County, Maryland, near Washington, DC, offers great public schools, public transportation, and a wealth of cultural and recreational choices.
Current Openings
How to Apply
Before applying, please download and read the full job description for more information on conditions of employment, selection and hiring requirements, and instructions on how to apply.
As a Digital Health Advisor, you will primarily serve as an expert who understands what it takes to develop, deliver, and maintain high quality digital health technologies during the FDA's review and evaluation of digital health technologies. Partnering with internal subject matter experts and external business and technology leaders, your goal is to stay current on technological advances, health benefits and risks, best practices, and help in development of the FDA's digital health policies and ongoing regulatory clarity.
Responsibilities
Specific responsibilities include, but are not limited to:
- Participate in the review and evaluation of first-of-a-kind digital health technologies and participate in precedent-setting research.
- Identify opportunities in creating preconditions and incentives informing digital health policy proposals, meeting the FDA's mission to protect and promote public health while supporting technological advances.
- Provide advice, consultations, and training to internal and external experts on current state of digital health technologies, policies, and functionalities.
- Assist with identifying and evaluating technology solutions that will enhance internal processes for FDA's Center for Devices and Radiological Health.
What is the FDA looking for in candidates?
- Comfortable in a fast-paced, customer-oriented, and flexible environment.
- A bias toward action and a proven track record of delivering projects and products.
- Have excellent communication skills to engage an organization of multiple specialties.
- Ability to actively seek out multiple opinions yet make independent decisions and influence positive outcomes.
- Have practical experience and technical expertise focusing on one or more areas of digital health, including:
- Mobile medical apps, medical device interoperability, and health care cybersecurity.
- Digital therapeutics, machine learning, artificial intelligence, and novel digital health technology.
- Digital health product development, software as a medical device.
- Big data and advanced analytics, cloud storage, and computing and wireless communication.
Position information
- Location: Silver Spring, Maryland (White Oak Campus)
- Salary: Salary is commensurate with education and experience
- Telework Eligible: Yes, as determined by supervisor
- Conditions of Employment: United States Citizenship is required
Data Science is revolutionizing the development of digital diagnostics and therapeutics, and advancements in the field promise to improve medical device regulation and oversight as well.
The FDA is excited about these advances and the convergence of medical devices with connectivity and consumer technology and has established the Digital Health Program to develop innovative approaches to regulating these technologies. Data Scientists in the Digital Health Center of Excellence help the FDA evaluate digital health medical devices and develop decision support tools and data pipelines to improve the evaluation of digital health medical devices.
As a Data Scientist, you will report to the Assistant Director for Emerging Digital Health Technology Assessment and Strategy in CDRH's Digital Health Center of Excellence (DHCoE), and will be responsible for planning, leading, and coordinating all data science related activities for the DHCoE.
Responsibilities
Specific responsibilities include, but are not limited to:
- Serve as a subject matter expert and provide administrative and technical oversight on the integration of in-depth data science knowledge into data analytic and visualization tools that will be utilized to support Office and Center leadership in making evidenced-based regulatory decisions concerning digital health devices, encompassing the entire product lifecycle.
- Provide expert guidance and share recommendations, with Team, Division, and Office leadership, on cloud-based solutions and custom software to support regulatory technology integration needs.
- Engage and educate the Digital Health Division and Office leadership on data as an integral enterprise asset within the current ecosystem and the importance of proper data governance, management, and stewardship.
- Advises the Assistant Director, Division Director, and Office leadership on the utilization of new and emerging technologies associated with artificial intelligence and machine learning in the analysis of digital health medical device data to detect early signals, trends, and other critical information that may not be visible upon routine inspection.
- Identify risks and encourage continuous improvements in data management through technological innovation and operational improvement.
- Analyzes data sets to determine their quality and informational content and cleanses them to maintain their use in regulatory analysis and decision-making.
- Forge mutually beneficial formal partnerships with medical device manufacturers, suppliers, carriers, foreign agencies, professional scientific organizations, health care community, patient advocacy groups, academia, and other federal, state, and local stakeholders.
- Apply expert knowledge of development, support, and analysis of data systems, including evaluating their effectiveness and determining appropriate enhancements to support the duties and responsibilities of the position.
- Keep abreast of evolving and state of the art regulatory policies and procedures and data/information science, data tools, and best practices.
- Drive the effort to reduce industry's administrative burden, continuously streamline technology, supporting product development, and facilitating innovation, without compromising the regulatory review process.
- Draft recommendations, most of which will be technical in nature, to describe data science activities, analysis, results, and conclusions to assist in supporting and advancing digital health medical device regulation.
What is the FDA looking for in candidates?
To qualify for this position, you must demonstrate in your resume the necessary qualifying experience, which includes the following:
- Leading large-scale enterprise data and information technology projects and programs.
- Solution focused Data Scientist with expertise in data management, reporting technologies, and knowledge of emerging technologies, such as databases, predictive analytics, and data visualization.
- Knowledge of development, support, and analysis of data systems, including evaluating their effectiveness and determining appropriate enhancement to support the duties and responsibilities of the position.
- Ability to analyze and interpret regulatory policy and guidance to share expertise and advise leadership on highly complex and precedent setting public health matters.
- Have wide-ranging technical expertise in medical device infrastructure development and implementation, business analytics, and modeling.
- Ability to effectively communicate through memoranda, position papers, and presentations to senior leaders and other clinical, engineering, technical, and scientific experts.
- Experience in developing, documenting, and promoting the components of data governance and analysis best practices.
Desirable Education:
- Applicants with degrees in computer science, computer engineering, cybersecurity, engineering, mathematics, or related field.
- Prior experience in a scientific, regulatory, or medical device manufacturing setting.
- Ability to work collaboratively with a diverse cadre of colleagues and stakeholders in a continuous quality improvement ecosystem.
Position information
- Location: Silver Spring, Maryland (White Oak Campus)
- Salary: Salary starts at $122,530.00 and is commensurate with education and experience.
- Telework Eligible: Yes, as determined by supervisor
- Conditions of Employment: United States Citizenship is required
Questions?
If you have any questions, email us at [email protected].