[Hiring] General Engineer / Biomedical Engineer @Tunnell Government Services

Role Description

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.

• Provide engineering, scientific, and regulatory expertise in support of medical device review and lifecycle management activities.
• Perform technical and regulatory reviews of medical devices, applying general and biomedical engineering principles.
• Evaluate scientific, engineering, clinical, and regulatory information submitted in support of various 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.
• Perform regulatory review, under guidance of Federal personnel.
• Assist in the development, documentation, and communication of recommendations related to device classification and regulatory status.
• Support the tracking, reporting, and management of device determination and custom device activities.
• Assist and coordinate the reporting and tracking of data integrity concerns.
• Prepare technical memoranda, briefing materials, decision documents, and responses to stakeholders.
• Support management by identifying trends, emerging technologies, and regulatory issues.
• Ensure that regulatory, scientific, engineering, and policy considerations are thoroughly addressed.
• Assure that policy considerations surrounding data integrity issues are adequately addressed.
• Coordinate assignments with necessary parties within the FDA Office and Center.

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, or related fields.
• Demonstrated technical capabilities to identify, analyze, and assist with data integrity issues.
• Demonstrated knowledge of medical device technologies and applicable FDA regulatory frameworks.
• Strong analytical and technical writing skills.
• Excellent verbal communication and interpersonal skills.
• Ability to work effectively both independently and as part of a multidisciplinary team.
• Proficiency in Microsoft Office Suite, including Outlook, Word, Excel, PowerPoint, and related applications.

Requirements

• Master's degree (M.S.), Ph.D., or other advanced degree in Biomedical Engineering, Engineering, Regulatory Science, or a related field (preferred).
• Experience supporting FDA regulatory submissions, including 510(k), De Novo, PMA, or related medical device submissions (preferred).
• Familiarity with FDA medical device classification and lifecycle management activities (preferred).
• Experience evaluating a broad range of medical device technologies and interpreting applicable regulations (preferred).
• Prior experience supporting FDA, CDRH, or other Federal regulatory programs is highly desirable (preferred).

Benefits

• Full Time Employee.
• Schedule: Monday through Friday (no Holidays).
• This position is 100% telework.
• Must be a US Citizen or full Green Card holder.