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 within the Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA), Office of Science and Engineering Laboratories (OSEL), located at 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: This project will offer the opportunity to analyze extractable and leachable chemicals from materials used in medical devices. This will include method development and validation for extraction, sample analysis using GC-MS and LC-MS, development of criteria for compound identification and quantification of substances contained in polymeric and other materials to support CDRH’s regulatory mission.

Learning Objectives: Under the guidance of a mentor, you will gain experience E&L data processing with focus on compound identification framework. You will also gain understanding of regulatory science and medical device biocompatibility review processes.

Mentor: The mentor for this opportunity is Samanthi Wickramasekara (samanthi.wickramasekara@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date: November 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.

The qualified candidate should be currently pursuing or have a doctoral degree in the one of the relevant fields. Degree must have been received within the past five years, or be currently pursuing.

Preferred skills:

• Hands-on experience in following techniques including but not limited to: sample preparation techniques (e.g., solid phase extraction, liquid-liquid extraction), liquid chromatography mass spectrometry (LC-MS), and gas chromatography mass spectrometry (GC-MS).
• Proven track record of handling mass spectrometers/ mass spectrometric data including both low resolution and high resolution/ accurate mass instruments.
• Using different mass spectral database platforms for compound identification and data interpretation tools (vendor specific and open source)
• Experience with computational software such as Python, R, MATLAB, Java, C++ etc.
• Experience in quantification of small molecules and polymers
• Experience in data analysis software packages, database generation and statistical evaluation
• An understanding of extractables studies and non-targeted analysis.
• Demonstration of a track record of independent research.
• Demonstrated ability to participate in multi-disciplinary teams and groups to resolve difficult or controversial research questions.
• Excellent scientific writing and communication skills.

• Degree: Doctoral Degree received within the last 60 months or currently pursuing.
• Discipline(s):
  • Chemistry and Materials Sciences (12 )
  • Computer, Information, and Data Sciences (5 )
  • Engineering (29 )
  • Life Health and Medical Sciences (51 )

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.) 
and
I have read the FDA Ethics Requirements.