FDA Cardiovascular Devices Research Fellowship

Overview

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available within the Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA), located at Silver Spring, Maryland.

Research Project: The FDA’s CDRH Cardiovascular Program conducts regulatory science research to ensure safe and effective cardiovascular devices like stents, pacemakers, and heart valves that have benefited millions of patients. The program addresses critical gaps including lack of credible preclinical blood damage assessment methods, overreliance on clinical data for device performance evaluation, durability issues in implants, and insufficient tools for predicting clinical outcomes. To fill these gaps, the program develops in vitro, in vivo, and computational models for comprehensive device evaluation. Research focuses on four areas: hemocompatibility testing for blood damage, hemodynamics assessment under simulated conditions, device durability evaluation, and electrophysiology methods for cardiac device safety.

Learning Objectives: Under the guidance of an FDA mentor, you will learn:?

Design and fabrication of samples and fixtures in CAD (e.g., SolidWorks)
Development of computational models and conduct simulations (e.g., ANSYS, Abaqus)
How to perform bench testing or characterization methodologies (e.g., mechanical, blood damage)
Programming (e.g., Python, g-code)
Data analysis
Statistical analyses
How to create reports
Mentor: The mentor for this opportunity is Prasanna Hariharan (Prasanna.Hariharan@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.

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.

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency.  This agreement covers such topics as the following:

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 an associate’s, bachelor’s, master’s, or doctoral degree in the one of the relevant fields. Degree must have been received within the past 60 months.