Medical Devices

Staff Fellow – Electrophysiology

Announcement Number: CDRH-OSEL-DBP-40

Position Title: Staff Fellow – Electrophysiology

Salary Range: $81,548 - $126,062 (depending upon education and experience)

Open Period: December 4, 2018 – January 4, 2019

Position Information: Full-Time – Excepted Service Time-Limited to 3 years. After completion of the first 3 years, the appointment can be extended in 3-year increments

Duty Location: Silver Spring, MD

Who May be Considered: US Citizens; Permanent Residents; and Non-Citizens. 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.

Job Summary: The Induced Pluripotent Stem Cell and Electrophysiology Laboratory, Division of Biomedical Physics in the FDA Center for Devices and Radiological Health, Office of Science and Engineering Laboratories is looking for a full-time scientist or biomedical engineer to join the group. The successful candidate will lead laboratory-based research to develop new tools for regulatory assessment of safety and efficacy of cardiac pacemakers, defibrillators, cardiac resynchronization therapy, cardiac ablation devices and other cardiac and neural electrophysiology devices using various biological models, including animal and human cellular and tissue models. In addition to a strong interest in providing scientific basis for regulatory decision made by the FDA, experience in one or more of the following areas is desired: cardiac or neural electrophysiology; cellular and tissue models; animal surgeries; induced pluripotent stem cells; microelectrode array recordings and data analysis; cardiac membrane potential recordings; electrophysiological instrumentation; fluorescent microscopy; microphysiological systems (organ-on-a-chip) use and fabrication; scientific computing with LabView, Python or similar; statistical data analysis with R, SAS or similar. Excellent writing skills are required. The position involves approximately 60% laboratory and computational research, and 40% policy or consulting support for reviews of new medical devices and analysis of device failures.

Educational Requirements: Applicants must possess a Ph.D. or equivalent degree in physics, biology, biophysics, chemistry, biomedical engineering or another relevant health science field. The applicant must be able to demonstrate mastery of principles and practices in laboratory research and safety testing. This will enable the staff fellow to serve as a technical authority in the scientific analysis of the safety and effectiveness of medical devices; provide an authoritative analysis of scientific data submitted to the Agency; and develop new and innovative approaches to scientific testing required for medical device reviews by FDA. Applicants who have completed part or all their education outside the US 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 US. 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.

Qualifications: Please document knowledge, skills, and abilities relevant to each area described below

  • A Ph.D. from an accredited university in biomedical engineering or a relevant health science field
  • At least three years of experience leading, planning, and conducting state-of-the-art laboratory research in one or more of the following fields: cardiac electrophysiology, neural electrophysiology, induced pluripotent stem cells, cellular and tissue models of human electrophysiology; animal surgeries; microphysiological systems (organ-on-a-chip) use and fabrication; scientific computing and statistical data analysis
  • Track record of independent work proven by publications in peer-reviewed journals
  • Demonstrated ability to participate in and contribute to multi-disciplinary teams and work groups to resolve difficult or controversial research questions.
  • Excellent scientific writing and communication skills.

How to Apply: To apply for this announcement, applicants should provide a complete application package to oselrecruitment@fda.hhs.gov that includes the following:

  • a cover letter with compensation requirements,
  • curriculum vitae,
  • two to three most relevant journal papers,
  • response, not to exceed one page total, to the five knowledge, skills, and abilities from the qualifications section and,
  • the names and contact information of three references.

Note: All supporting documents should include the announcement number.

Applications should be sent via email to oselrecruitment@fda.hhs.gov or mailed to the attention of Valerie McRae, FDA/CDRH/OSEL, 10903 New Hampshire Avenue, Building 62, Room 4206, Silver Spring, MD 20993-0002. Applications must be received by closing date to be considered. Electronic submission of application materials is encouraged. Applications sent via e-mail must be submitted as MS Word, or Adobe pdf documents.

Contact Valerie McRae for Questions: Valerie.McRae@fda.hhs.gov

  1. Security and Background Requirements: 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 action.

  2. Benefits: The Federal Government offers a comprehensive benefits package. Explore the major benefits offered to most Federal employees at https://www.usa.gov/benefits-for-federal-employees

Page Last Updated: 12/06/2018
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