Biomedical Engineer / Regulatory Scientific Reviewer (MedSun Analyst)

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FDA CDRH -- October 2026 Biomedical Engineer – Regulatory Scientific Reviewer (MedSun Analyst) Position Title: Biomedical Engineer/Regulatory Scientific Reviewer – MedSun Analyst Employment Type: Full-Time Employee Schedule: Monday–Friday, excluding holidays Position Summary The Biomedical Engineer / Regulatory Scientific Reviewer (MedSun Analyst) provides scientific, engineering, and regulatory support to FDA's Center for Devices and Radiological Health (CDRH) Total Product Life Cycle (TPLC) oversight activities. The incumbent supports post market surveillance initiatives through the review, analysis, and interpretation of real-world medical device performance and safety data, including advanced analytic-generated signal alerts from FDA's Medical Data Enterprise. The position plays a role in the operation and management of FDA's Medical Product Safety Network (MedSun), a nationally recognized surveillance program established under Section 519(b)(5)(A) of the Federal Food, Drug, and Cosmetic Act. MedSun connects FDA with more than 300 healthcare facilities nationwide to identify emerging medical device safety and quality issues and support timely, evidence-based regulatory decision making. The Biomedical Engineer / Regulatory Scientific Reviewer serves as a technical subject matter expert, applying engineering principles, clinical knowledge, and post market surveillance expertise to assess medical device safety, effectiveness, quality, and performance concerns. Essential Duties And Responsibilities Medical Device Surveillance and Signal Evaluation Review, assess, and triage automated signal alerts generated through FDA's Medical Data Enterprise and other surveillance systemsAnalyze medical device adverse event reports, safety signals, trends, and emerging issues to identify potential public health concernsEvaluate complex scientific, clinical, engineering, and operational data related to medical device performance, safety, and effectivenessContribute to Total Product Life Cycle (TPLC) oversight activities through evidence-based assessment and interpretation of post market dataSupport the identification, validation, prioritization, and management of potential safety signals requiring regulatory review MedSun Program Operations Support the day-to-day operation of the MedSun network and engagement with participating healthcare facilitiesServe as a liaison between FDA and MedSun user facilities to facilitate reporting and information exchange regarding medical device safety issuesConduct outreach activities, information gathering, and follow-up investigations with healthcare providers and clinical engineering personnelAssist with development of MedSun communications, reports, educational materials, and presentationsPromote high quality reporting and surveillance activities among participating facilities Scientific and Regulatory Review Review medical device incident reports, complaint data, recall information, and related surveillance dataConduct technical evaluations of device-related incidents and system failuresPerform root cause analyses and assist with investigations involving medical device-related adverse eventsApply risk management methodologies, including failure mode and effects analysis (FMEA), hazard assessment, and mitigation strategiesPrepare scientific reviews, briefing materials, technical memoranda, and regulatory recommendations for FDA leadership and multidisciplinary review teamsProvide objective, well-supported scientific interpretations to support regulatory decision making Minimum Qualifications Education Bachelor of Science degree or higher in Biomedical Engineering from an ABET-accredited engineering program. OR Bachelor of Science degree or higher in a comparable engineering discipline, supplemented by professional specialty experience in biomedical engineering, clinical engineering, or healthcare technology management. Professional Experience Experience working within a healthcare system, hospital, integrated delivery network, or clinical services organization supporting healthcare technology managementExperience working with clinical staff regarding the safety, effectiveness, performance, and operational use of medical devicesExperience evaluating medical equipment used in patient care and healthcare delivery environments Preferred Qualifications Specialized Expertise Demonstrated knowledge and experience in one or more of the following areas: Medical device safety and effectiveness assessmentPost market surveillance programsMedical device adverse event reporting and analysisRecall management and corrective actionsMedical device incident investigationRoot cause analysisMedical device forensicsFailure Mode and Effects Analysis (FMEA)Hazard mitigation and risk managementSignal detection, evaluation, and management Preferred Skills Strong analytical and critical thinking skills with the ability to evaluate complex scientific, engineering, and healthcare related informationAbility to synthesize information from multiple sources and stakeholders in an objective and unbiased mannerDemonstrated initiative in identifying additional data, context, and insights that support informed decision makingExcellent written and verbal communication skillsAbility to prepare professional reports, presentations, and regulatory review documentsStrong interpersonal and collaboration skillsExperience leading stakeholder engagement and outreach activitiesProficiency in reviewing and interpreting scientific, clinical, technical, and operational data Preferred Certification Certified Clinical Engineer (CCE) credential preferred 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.