[Hiring] Vision Scientist @Tunnell Government Services

Role Description

Tunnell has a contract opportunity available supporting the Division of Ophthalmic Devices (DOD) within the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration. A Vision Scientist is needed to conduct scientific and regulatory reviews to evaluate the safety and effectiveness of new ophthalmic devices. This is a remote position.

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
• Planning and coordinating post-market compliance and enforcement efforts related to medical devices

Duties of the Vision Scientist may include but are not limited to:

• Reviewing total product life-cycle actions (premarket, compliance, and post-market surveillance) related to ophthalmic devices.
• Applying technical expertise to determine the adequacy of methodology, protocols, and data concerning bench, animal, and/or clinical testing.
• Providing recommendations of submission clearance, approval, disapproval, or request for additional information.
• Preparing comprehensive memos supporting recommendations and appropriate correspondence to applicants.
• Assisting with developing, modifying, and evaluating guidelines concerning data required in medical device actions.
• Presenting reviews, conclusions, opinions, and recommendations to appropriate scientific review panels.
• Enhancing professional career development by collaborating with other scientists and keeping abreast of current events and findings.

Qualifications

• Solid background in basic and/or clinical visual psychophysics, visual optics, and optical instrumentation.
• Background and experience in optics, optical design software, and manufacturing optical test equipment.
• Research experience with human participants, including clinical trial design and management.
• Experience in the manufacture, quality control, and validation/verification testing of ophthalmic optical devices.
• Expertise in critically reviewing scientific documents and skill in clearly communicating review results.
• Background in the following technical areas is highly desirable:
  • Visual Neuroscience
  • Neuroanatomy and neurophysiology of the retina and visual pathways
  • Visual electrophysiology (clinical and basic)
  • Functional imaging of visual pathways
  • Optics of the eye
  • Sources of retinal scattered light and its effects on retinal image quality
  • Retinal image quality as a function of eccentricity
  • Optics of photoreceptors
  • Light hazard analysis and mechanisms of light damage to the eye
• Low Vision expertise in clinical psychophysical & optical testing.

Requirements

• Doctoral level degree (e.g., Ph.D., M.D., D.O.) in a relevant field is preferred; however, a M.S. in Life Sciences/Engineering discipline combined with extensive experience with ophthalmic devices may also be acceptable.
• Minimum of 10 years’ experience in fields directly relevant to the Vision Scientist position.
• Experience authoring and evaluating responses to and from Regulatory Agencies is desired.
• Demonstrated capability of proficient written and oral communication.
• This position is 100% telework.
• Must be a US Citizen or full Green card holder.

Benefits

• Tunnell strives to hire and retain the most qualified talent.
• We believe that having employees with different backgrounds and capabilities contributes to the success of our business.
• All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.