General Engineer / Biomedical Engineer SME

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
• Demonstrated knowledge of medical device technologies and applicable FDA regulatory frameworks
• Strong analytical and technical writing skills, with the ability to clearly communicate complex scientific, engineering, and data integrity concepts
• Excellent verbal communication and interpersonal skills, with a proven ability to bridge communications between front-line review staff and senior management
• Ability to work effectively both independently and as part of a multidisciplinary team of scientific, engineering, and regulatory professionals
• Proficiency in Microsoft Office Suite, including Outlook, Word, Excel, PowerPoint, and related applications

Preferred Qualifications

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

This position requires a highly skilled engineering professional capable of providing independent scientific and technical analysis while supporting the FDA's mission to ensure the safety and effectiveness of medical devices throughout their regulatory lifecycle.

Job Type:  Full Time Employee

Schedule:  Monday through Friday (no Holidays)

Location:  This position is 100% telework 

Must be a US Citizen or full Green Card holder.