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US Food and Drug Administration

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FDA Development of a Queryable Technological Parameter Library for Energy-Based Surgical Devices Indexed by Indications for Use (IFU) U.S. Food and Drug Administration (FDA) in United States

Degree Level

PhD

Field of study

Computer Science

Funding

Monthly stipend commensurate with educational level and experience; appointment initially for one year and may be renewed upon recommendation of FDA, contingent on availability of funds.

Deadline

Nov 15, 2026

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Country

United States

University

US Food and Drug Administration

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Keywords

Computer Science
Biomedical Engineering
Electrical Engineering
Medical Science
Regulatory Science
Physics

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About this position

This research opportunity is based within the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration, where the participant will contribute to regulatory science work supporting the review of medical devices in the United States. The project centers on energy-based surgical devices (EBSDs) and the development of a centralized, queryable library of device parameters indexed by indications for use.

The participant will systematically identify, extract, and organize key treatment parameters such as power output, exposure time, and frequency, together with technical parameters including wavelength, impedance, and beam profile. These data will be mapped to clinical indications and assembled into a resource that helps reviewers surface benchmarks, compare device specifications against cleared predicates, and identify gaps in submitted information.

The work involves comprehensive review of FDA marketing authorizations, applicable consensus standards, and relevant clinical literature, with the goal of populating a workspace that supports more efficient and consistent regulatory review. The project also explores use of AI-enabled and regulatory informatics platforms, including ELSA, Python Vibe Coding, and the CDRH-CARS System, to curate and query technical and clinical evidence.

More broadly, the project is intended to support development of FDA guidance documents and reviewer resources by consolidating performance testing information and parameter criteria for specific device types.

Funding details

Monthly stipend commensurate with educational level and experience; appointment initially for one year and may be renewed upon recommendation of FDA, contingent on availability of funds.

What's required

The qualified candidate should be currently pursuing or have received a bachelor's, master's, or doctoral degree in a relevant field. Applicants must submit an application, transcripts, a current resume/CV including academic history, employment history, relevant experiences, and publication list, and one educational or professional recommendation. All documents must be in English or include an official English translation. The opportunity is open to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals; non-U.S. citizens must meet acceptable immigration status requirements. Proof of health insurance is required, and completion of a successful background investigation by the Office of Personnel Management is required for onboarding at FDA, with the additional residency condition that OPM can complete a background investigation only for individuals who have resided in the U.S. for a total of three of the past five years.

How to apply

Apply through the Zintellect opportunity page and scroll to the bottom of the posting to click APPLY. Prepare an application, transcripts, a current resume/CV, and one recommendation, all in English or with official English translations. If you have questions, email [email protected] and include the reference code FDA-CDRH-2026-0028.

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