FDA Development of a General Surgery Devices Database and Analysis to Identify Key Technological Attributes and Trends

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 28,000 - 39,000; Full time

Job summary

Oak Ridge Institute for Science and Education (ORISE) offers a research participation opportunity with the U.S. FDA, located in Silver Spring, Maryland.

The fellowship focuses on developing a database of robotic surgical device technologies and understanding regulatory pathways, with mentorship and project-based learning in a regulatory science environment. The appointment starts in 2026, is full-time for one year and may be renewed.

Qualifications

• Currently pursuing or have received a bachelor's, master's, or doctoral degree in one of the relevant fields.

Responsibilities

• Collaborate with review staff to develop a database of robotic surgical device technologies across the FDA/CDRH Office of Product Evaluation and Quality (OPEQ).
• Learn regulatory pathways (510(k), De Novo, PMA) and how device characteristics influence pathway selection for submissions.
• Gain familiarity with FDA internal data systems, submission databases, and review processes.

Education

Bachelor's/Master's/Doctoral degree

Job description

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CDRH-2026-0024

All documents must be in English or include an official English translation.

If you have questions, send an email to [e-mail]. Please include the reference code for this opportunity in your email.

Application Deadline

10/29/2027 3:00:00 PM Eastern Time Zone

Description

• 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

• 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 ([e-mail]). 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.

FDA Ethics Requirements

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.

Education

• Non-employee nature of the ORISE appointment;
• Prohibition on ORISE Fellows performing inherently governmental functions;
• Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
• The fact that research materials and laboratory notebooks are the property of the FDA;
• ORISE fellow’s obligation to protect and not to further disclose or use non-public information.

Qualifications

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.

Point of Contact

Ashley

Eligibility Requirements

• Degree: Bachelor's Degree, Master's Degree, or Doctoral Degree.
• Discipline(s):
  • Engineering
    • Aerospace and Aeronautical
    • Agricultural Engineering
    • Architectural Engineering
    • Bioengineering and Biomedical Engineering
    • Biological/Biosystems Engineering
    • Chemical Engineering
    • Civil Engineering
    • Communications Engineering
    • Computer and Systems Engineering
    • Electrical and Electronic Engineering (including Cybersecurity)
    • Energy
    • Engineering (General)
    • Engineering Physics
    • Engineering Sciences
    • Environmental Engineering
    • Geophysical Engineering
    • Industrial Engineering
    • Materials Science Engineering
    • Mechanical Engineering
    • Mechatronics, Robotics, and Automation Engineering
    • Metallurgical Engineering
    • Mining and Minerals Engineering
    • Naval Architecture and Marine Engineering
    • Nuclear Engineering
    • Ocean Engineering
    • Petroleum Engineering
    • Polymer Engineering
    • Radiation Protection
    • Systems Engineering (including Human Systems)
  • Life Health and Medical Sciences
    • Physics
• Affirmation

  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.)

  I have read the FDA Ethics Requirements.