American Council of Engineering Companies of Colorado

CDRH - OPEQ Total Product Life Cycle Fellowship Program

Introduction: The Center for Devices and Radiological Health (CDRH), as the scientific and regulatory component of the U.S. Food and Drug Administration (FDA) charged with facilitating and ensuring medical device innovation, safety, and effectiveness, and advancing regulatory science is now accepting applications for our Total Product Life Cycle (TPLC) Fellowship Program.  This exciting new Fellowship Program will be housed and administered by the Office of Product Evaluation and Quality (OPEQ or Office).  OPEQ is responsible for ensuring the comprehensive and quality end-to-end evaluation of medical devices and the consistent interpretation and application of regulatory policy and guidance.  This Office will offer the right public health minded candidates unique career enhancing opportunities to learn and be a part of the scientific and regulatory review processes of medical devices, both existing and those with novel and emerging technologies.  This Fellowship opportunity is open to recent graduates and scientific professionals who graduated within the last two (2) years.

Position Summary: CDRH is seeking qualified candidates to serve as Staff Fellows in our newly established TPLC Fellowship Program.  Over the course of two (2) years, you will receive expert training, guidance, and mentorship to assist you in developing the requisite knowledge and skills to become integral members of our medical device review teams.  Although, a Ph.D. is preferred, we are accepting applications from qualified baccalaureate and masters prepared May 2022 graduates and scientific professionals who graduated within the past two (2) years. Through guided rotational assignments in our device specific Offices, you will have the opportunity to apply your scientific, engineering, mathematical, and statistical education and experiences, while developing and advancing your technical, regulatory science, and medical device knowledge.

Educational Requirements:  Applicants must possess a Baccalaureate, Masters, Ph.D., Sc.D. or equivalent degree in Biology, Microbiology, Chemistry, General Engineering, Bioengineering and Biomedical Engineering, Chemical Engineering, Computer Engineering, Electrical Engineering, Electronics Engineering, Materials Engineering, Materials Science, Mechanical Engineering, Epidemiology, Mathematical Statistics, Statistics, Pharmacology, Physics, Toxicology or related health or scientific field/course of study.  Applicants who have completed part or all their education outside the U.S. must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.S. This evaluation must also be provided by midnight Eastern Time on the closing date of this vacancy announcement. For more information on Foreign Education verification, visit the U.S. Department of Education.  Another listing of services that can perform this evaluation is available at the National Association of Credential Evaluation Services (NACES) website.

Desirable Education, Experience, and Qualifications: Please document education, knowledge, skills, and abilities:

• D. or equivalent degrees from an accredited university in Biology, Chemistry, or Engineering is preferred.
• Demonstrated track record of academic excellence, professional experience, and commitment to public health.
• Excellent writing and oral communication skills.

How to Apply:  Submit an electronic resume or curriculum vitae, cover letter describing your interest in the Fellowship Program, and a copy of your unofficial transcripts all in one document (Adobe PDF) to CDRHRecruitment@fda.hhs.gov, with Job Reference code “2022-OPEQ-TPLC Fellowship” in the subject line. Applications will be accepted through June 24, 2022.

Additional Qualifications: To qualify as a Staff Fellow, you must: be a US Citizen, Permanent Resident, or Non-Citizen with residency status in the U.S., three (3) out of the last five (5) years; possess a doctoral-level degree from an accredited institution of higher learning, to include: Ph.D., M.D., D.V.M., D.D.S., D.M.D., Sc.D., or other research doctoral-degree widely recognized in U.S. academe as equivalent to a Ph.D. (In limited instances non-doctoral candidates, and/or candidates with less experience may be acceptable).

Conditions of Employment

• A probationary period may be required.
• This position is for a two (2) year appointment and will be filled through FDA’s Staff Fellowship Program
• A background and/or Security investigation
• Applicants who are U.S. Citizens and born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved
• This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For additional information, please visit the FDA Ethics and Integrity Office.

Salary: Starting salary ranges from $38,503.00 to $74,074.00, plus locality pay and is commensurate with education, experience, and candidate’s location.

Position Levels:  Staff Fellow positions for this Fellowship Program will be filled at the equivalent pay grades of the General Schedule (GS) 7 to 11.  For additional salary information, click here.

Location(s):  Candidate’s duty station location will be determined upon selection.  Telework/remote opportunities are available.     

Additional Announcement Information

COVID-19:  Due to COVID-19, the Agency is currently in an expanded telework posture. If selected, you may be expected to temporarily telework, even if your home is located outside the local commuting area. Once employees are permitted to return to the office, you will be expected to report to the duty station listed on this announcement within 45 days. At that time, you may be eligible to request to continue to telework one or more days a pay period depending upon the terms of the agency's telework policy. As required by Executive Order 14043, Federal executive branch employees are required to be fully vaccinated against COVID-19 regardless of the employee's duty location or work arrangement (e.g., telework, remote work, etc.), subject to such exceptions as required by law. If selected, you will be required to be vaccinated against COVID-19 and will receive instructions on how to provide documentation.

1. Security and Background Requirements: All candidates must meet applicable security requirements which include a background check and a minimum of 3 out of the past 5 years’ residency status in the US. If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant’s successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection, or appropriate disciplinary
2. Benefits: The Federal Government offers a comprehensive benefits Explore the major benefits offered to most Federal employees at https://www.usa.gov/benefits-for-federal-employees
3. Travel, transportation and relocation expenses will not be paid.

HHS/FDA is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.