FDA Development of a General Surgery Devices Database and Analysis to Identify Key Technological Attributes and Trends
To submit your application, scroll to the bottom of this opportunity and click APPLY.
A complete application consists of:
- An application
- Transcripts – Click here for detailed information about acceptable transcripts
- A current resume/CV, including academic history, employment history, relevant experiences, and publication list
- One educational or professional recommendation
All documents must be in English or include an official English translation.
If you have questions, send an email to ORISE.FDA.CDRH@orau.org. Please include the reference code for this opportunity in your email.
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*Applications will be reviewed on a rolling-basis.
FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), located in Silver Spring, Maryland.
Oak Ridge Institute for Science and Education (ORISE) Research Participation Programs at the U.S. Food and Drug Administration are educational training programs designed to provide students and recent graduates, opportunities to participate in project-specific research and developmental at the Center for Devices and Radiological Health (CDRH). The mission of CDRH is to protect and promote public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH provides consumers, patients, caregivers, and providers with understandable and accessible science-based information about products. CDRH facilitates 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.
Research Project: You will collaborate with review staff to develop a database of robotic surgical device technologies across the Office of Product Evaluation and Quality (OPEQ). This project will help categorizing key technological attributes defining various classes of robotic devices, the timing for when key technologies have been introduced, and trends in the dissemination of technologies across different categories of robotic surgical devices.
Learning Objectives: Under the guidance of a mentor, you will:
- Learn how to identify the key technological attributes that define and differentiate various robotic surgical devices.
- Develop an understanding of regulatory pathways, including 510(k), De Novo, and Premarket Approval (PMA), and how technological characteristics may influence pathway selection for robotic surgical device submissions.
- Gain familiarity with different generations of robotic surgical technologies, including teleoperated systems, automated functions, and artificial intelligence-enabled technologies.
- Learn how FDA internal data systems, submission databases, and review processes are used in the evaluation of robotic surgical devices.
Mentor: The mentor for this opportunity is Gabrielle Clark-Patterson, PhD, General Engineer, Office of Surgical and Infection Control Devices (Gabrielle.Clark-Patterson@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.
Anticipated Appointment Start Date: 2026. Start date is flexible and will depend on a variety of factors.
Appointment Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.
Level of Participation: The appointment is full time.
Participant Stipend: The participant will receive a monthly stipend commensurate with educational level and experience.
Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
The qualified candidate should be currently pursuing or have received a bachelor's, master's, or doctoral degree in the one of the relevant fields.
I am a U.S. Citizen, or I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)
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