Description

The Division of Ophthalmic Devices (DOD) at the Food and Drug Administration seeks to hire a vision scientist and an optical engineer/scientist reviewer to evaluate the safety and effectiveness of new ophthalmic devices. 

DOD serves as the primary source for scientific and medical expertise on ophthalmic medical devices with regard to safety and effectiveness. The Division carries out scientific and end-to-end medical device review evaluation, including, coordinating and making premarket review determinations, as well as, planning and coordinating post market compliance and enforcement efforts related to medical devices. The incumbent serves as a Reviewer within the Center for Devices and Radiological Health (CDHR) Office of Health Technology 1, to conduct scientific and regulatory reviews.

DUTIES:

Duties of a scientific reviewer may include but are not limited to:

• With guidance and direction from senior scientist and engineers, the reviewer will review total product life-cycle actions (premarket, compliance, and post-market surveillance) related to ophthalmic devices. Actions may include 510(k)s, PMAs, De Novos, IDEs, pre-submissions, submission issue requests, 513(g)s, recalls and complaint submissions. Reviewer will apply his/her technical expertise to determine the adequacy of methodology, protocols and data concerning bench, animal and/or clinical testing and will, as needed, obtain appropriate consultation reviews of methodology, protocols and data that are outside the scope of the reviewer’s expertise. Based on a collective evaluation of the submission, the reviewer will provide a recommendation of submission clearance, approval, disapproval, request additional information or provide scientific and/or regulatory feedback to applicants. For each submission, the reviewer will prepare a comprehensive memo supporting the recommendation and, when required, prepare the appropriate correspondence to the applicant.
• Assist with the developing, modifying, and evaluating guidelines concerning data required in medical device actions to be submitted to the Agency. In this capacity, the reviewer participates as a member of a team of experts to develop agency or center-wide guidelines applicable to the regulation of relevant medical devices.
• Present reviews, conclusions, opinions, and recommendations to appropriate scientific review panels on PMAs, petitions for reclassification, etc. These presentations will include key issues pertaining to the safety and effectiveness of the medical device(s), outlines of deficiencies, and recommendations for approval or non-approval of the device or the submission.
• Enhance professional career development by collaborating with other scientists to better understand medical device problems. Keep abreast of current events and findings and changes in medical device law and regulations through review of scientific and legislative literature, personal contact with relevant authorities, and by attending scientific meetings.
• Reports directly to the appropriate Division Assistant Director, and performs other duties as assigned.

QUALIFICATIONS – VISION SCIENTIST

The candidate should have a solid background in basic and/or clinical visual psychophysics, visual optics, and optical instrumentation as evidenced by a record of independent, peer-reviewed published research.

A highly qualified candidate will have research experience with human participants including clinical trial design and management, especially clinical research involving ophthalmic devices (e.g., surgical lasers, imaging devices, diagnostic visual tests, ocular implants).  Expertise in critically reviewing scientific documents and skill in clearly communicating review results are essential.  Background in the following technical area(s) is highly desirable:

• Visual Neuroscience
• Neuroanatomy and neurophysiology of the retina and visual pathways
• Visual electrophysiology, both clinical (ERG, VEP, etc.) and basic (single & multi-cell recording, retinal/LGN/cortical circuitry, electrical stimulation of visual pathways)
• Functional imaging of visual pathways (e.g., functional MRI, opto-genetics, fluorescence)
• Optics of the eye
• Sources of retinal scattered light and its effects on retinal image quality in fovea and periphery
• Retinal image quality (resolution and contrast) as a function of eccentricity
• Optics of photoreceptors
• Light hazard analysis, and mechanisms of light damage to the eye.
• Low Vision
• Clinical psychophysical & optical testing
• contrast sensitivity,
• low contrast acuity,
• mesopic acuity,
• perimetry,
• color vision testing,
• stereopsis, binocular vision
• pupillometry,
• aberrometry
• accommodation testing
• light & dark adaptation
• psychophysical methodology

QUALIFICATIONS – OPTICAL ENGINEER/SCIENTIST

The candidate should have a solid background in optics, optical design software and manufacturing optical test equipment as evidenced by education and relevant work history.

A highly qualified candidate will have experience in the manufacture, quality control, validation/ verification testing of ophthalmic optical devices (e.g., intraocular lenses and contact lenses). Expertise in critically reviewing scientific test reports and skill in clearly communicating review results are essential. 

You must be a U.S. Citizen or permanent resident to be considered. 

This may be a remote position.

If you have any interest in this position, please provide a cover letter and curriculum vitae to CDRH-JOBS-Ophthalmic@fda.hhs.gov.

FDA/Center for Devices and Radiological Health

Office of Product Evaluation and Quality

Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices

Visit us @

https://www.fda.gov/about-fda/cdrh-offices/office-product-evaluation-and-quality

FDA IS AN EQUAL OPPORTUNITY EMPLOYER AND HAS A SMOKE FREE ENVIRONMENT.

TO QUALIFY FOR EMPLOYMENT, ALL APPLICANTS MUST MEET ALL CIVIL SERVICE OR COMMISSIONED CORPS REQUIREMENTS INCLUDING U.S. CITIZENSHIP.