Would you or someone you know be excited by the challenge of serving as an influential change agent in the area digital health, while simultaneously making an impact on the health of the American public? The Food and Drug Administration (FDA), is conducting a search for applicants to fill Interdisciplinary Engineer positions in our Center for Devices and Radiological Health (CDRH). This is an excellent career opportunity to become part of the digital health team at FDA that is charged with coordinating digital health activities across CDRH. Applicants will be at the forefront and helping FDA enhance its bench strength in applying pragmatic, sensible and nimble oversight that allows innovators to create products that are safe and effective in digital health. This is a unique opportunity for talented individuals to bring industry experience and talent to FDA to protect and promote public health.
Successful candidates will be talented, innovative, out-of-the-box thinkers with industrial experience that are capable of providing technical expertise in one or more of the following digital health focus areas: software lifecycle management processes (premarket and post market), mobile medical apps, medical device interoperability, healthcare cybersecurity, wireless technologies, cloud-enabled software deployment, machine learning/artificial intelligence, big data, advanced analytics, digital health product development, and program management. Applicants must be able to support FDA work groups establishing digital health regulations, procedures, and programs having national or international impact. Candidates will also need to provide subject matter expertise and serve as CDRH resources in the application of existing digital health policies to promote innovation while balancing benefit and risk for digital health products.
Providing technical expertise in one or more of the following digital health focus areas: Software lifecycle management processes (premarket and post market), mobile medical apps, medical device interoperability, healthcare cybersecurity, wireless technologies, cloud-enabled software deployment, machine learning/artificial intelligence, big data, advanced analytics, digital health product development, and program management.
Participating as a subject matter expert, when necessary, in premarket and postmarket review of digital health products.
Identifying opportunities and risks for modifying CDRH's digital health approach to premarket review and postmarket surveillance of medical devices to promote timely, efficient scientific assessment and review of innovative products.
Managing all aspects of total product lifecycle (concept and development through maintenance and product retirement) for software and digital health products.
Advising other engineers or scientists concerning software-related medical device and digital health policy.
Analyzing and evaluating policies that impact digital health.
Identifying technology trends and evolving science that may influence digital health technologies, medical device development, evaluation, and regulatory policy.
Performing software engineering work on digital health products and medical device.
Developing and delivering training on new digital health technology regulations, procedures, and programs to key stakeholders.
This position will be located in Silver Spring, Maryland. The annual salary range is from $112,021 to $145,629.
FDA is an equal opportunity employer and we encourage applications from a diverse pool of high quality candidates. All applicants will receive consideration without regard to ethnicity, gender, national origin, age, religion, disability, or sexual orientation.
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The world renowned U.S. Food and Drug Administration (FDA), is a government agency that is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The Center for Devices and Radiological Health (CDRH), part of the U.S. Food... and Drug Administration (FDA), assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S. FDA is an equal opportunity employer and encourages applications from a diverse pool of high quality candidates. FDA offers its employees a wide array of benefits.