Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us.

General Engineer/Biomedical Engineer SME Position Description

FDA CDRH Office of Regulatory Programs (ORP) Device Determinations and Custom Devices Lifecycle Team

The FDA Center for Devices and Radiological Health (CDRH), Office of Regulatory Programs (ORP), seeks an experienced General Engineer or Biomedical Engineer Subject Matter Expert (SME) to provide scientific, engineering, regulatory science, and technical support for the evaluation of medical devices. This position supports the Device Determinations and Custom Devices Lifecycle Team, which is responsible for managing key regulatory pathways and activities, including 510(k) notifications, De Novo classification requests, 513(g) Requests for Information, official device determinations, and the Custom Device Exemption Program.

Duties and Responsibilities

The Contractor shall provide engineering, scientific, and regulatory expertise in support of medical device review and lifecycle management activities. Specific responsibilities include:

Perform technical and regulatory reviews of medical devices, applying general and biomedical engineering principles to assess device design, intended use, technological characteristics, performance data, and regulatory status
Evaluate scientific, engineering, clinical, and regulatory information submitted in support of 510(k) notifications, De Novo requests, 513(g) requests, device determination inquiries, Custom Device Exemption requests, and related regulatory submissions
Analyze complex engineering and scientific issues to support regulatory recommendations and decision making
Assist in the preparation and evaluation of official device determinations regarding product classification, jurisdiction, and applicable regulatory pathways
Coordinate with subject matter experts, review divisions, and offices throughout CDRH and FDA to ensure consistent application of regulatory requirements, policy, and scientific standards
Perform regulatory review, under guidance of Federal personnel, utilizing expertise available throughout the FDA Office and Center
Assist in the development, documentation, and communication of recommendations related to device classification, regulatory status, custom devices, and other lifecycle management matters
Support the tracking, reporting, and management of device determination and custom device activities, ensuring reviews, decisions, and supporting rationale are properly documented
Assist and coordinate the reporting and tracking of data integrity concerns
Prepare technical memoranda, briefing materials, decision documents, and responses to internal and external stakeholders
Support management by identifying trends, emerging technologies, and regulatory issues that may affect device determination and custom device programs
Ensure that regulatory, scientific, engineering, and policy considerations are thoroughly addressed through coordination with relevant FDA stakeholders and review teams
Assure that policy considerations surrounding data integrity issues are adequately addressed through coordination with other teams
Coordinate assignments with necessary parties within the FDA Office and Center

Minimum Qualifications

Bachelor's degree (B.S.) in Engineering, Biomedical Engineering, or a closely related engineering discipline
Minimum of seven (7) years of professional experience in engineering, medical devices, regulatory affairs, regulatory science, product development, product evaluation, or a related field
Demonstrated technical capabilities to identify, analyze, and assist with data integrity issues existing within scientific review processes