General Engineer / Biomedical Engineer

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 statusEvaluate 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 submissionsAnalyze complex engineering and scientific issues to support regulatory recommendations and decision makingAssist in the preparation and evaluation of official device determinations regarding product classification, jurisdiction, and applicable regulatory pathwaysCoordinate with subject matter experts, review divisions, and offices throughout CDRH and FDA to ensure consistent application of regulatory requirements, policy, and scientific standardsPerform regulatory review, under guidance of Federal personnel, utilizing expertise available throughout the FDA Office and CenterAssist in the development, documentation, and communication of recommendations related to device classification, regulatory status, custom devices, and other lifecycle management mattersSupport the tracking, reporting, and management of device determination and custom device activities, ensuring reviews, decisions, and supporting rationale are properly documentedAssist and coordinate the reporting and tracking of data integrity concernsPrepare technical memoranda, briefing materials, decision documents, and responses to internal and external stakeholdersSupport management by identifying trends, emerging technologies, and regulatory issues that may affect device determination and custom device programsEnsure that regulatory, scientific, engineering, and policy considerations are thoroughly addressed through coordination with relevant FDA stakeholders and review teamsAssure that policy considerations surrounding data integrity issues are adequately addressed through coordination with other teamsCoordinate 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 disciplineMinimum of seven (7) years of professional experience in engineering, medical devices, regulatory affairs, regulatory science, product development, product evaluation, or a related fieldDemonstrated technical capabilities to identify, analyze, and assist with data integrity issues existing within scientific review processesDemonstrated knowledge of medical device technologies and applicable FDA regulatory frameworksStrong analytical and technical writing skills, with the ability to clearly communicate complex scientific, engineering, and data integrity conceptsExcellent verbal communication and interpersonal skills, with a proven ability to bridge communications between front-line review staff and senior managementAbility to work effectively both independently and as part of a multidisciplinary team of scientific, engineering, and regulatory professionalsProficiency 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 fieldExperience supporting FDA regulatory submissions, including 510(k), De Novo, PMA, or related medical device submissionsFamiliarity with FDA medical device classification, device determination processes, and lifecycle management activitiesExperience evaluating a broad range of medical device technologies and interpreting applicable regulations, guidance documents, and standardsPrior 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. 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. To attract qualified applicants, Tunnell posts to a wide variety of job sites. 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. Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.