Biomedical Engineer / Regulatory Scientific Reviewer (MedSun Analyst)
tunnell government servicesBethesda (MD)
Biomedical Engineer / Regulatory Scientific Reviewer (MedSun Analyst)
Posted today
tunnell government servicesBethesda (MD)
SENIORITY
Lead
About the role
Biomedical Engineer – Regulatory Scientific Reviewer (MedSun Analyst) 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 systems
- Analyze medical device adverse event reports, safety signals, trends, and emerging issues to identify potential public health concerns
- Evaluate complex scientific, clinical, engineering, and operational data related to medical device performance, safety, and effectiveness
- Contribute to Total Product Life Cycle (TPLC) oversight activities through evidence-based assessment and interpretation of post market data
- Support 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 facilities
- Serve as a liaison between FDA and MedSun user facilities to facilitate reporting and information exchange regarding medical device safety issues
- Conduct outreach activities, information gathering, and follow-up investigations with healthcare providers and clinical engineering personnel
- Assist with development of MedSun communications, reports, educational materials, and presentations
- Promote high quality reporting and surveillance activities among participating facilities
- Scientific and Regulatory ReviewReview medical device incident reports, complaint data, recall information, and related surveillance data
- Conduct technical evaluations of device-related incidents and system failures
- Perform root cause analyses and assist with investigations involving medical device-related adverse events
- Apply risk management methodologies, including failure mode and effects analysis (FMEA), hazard assessment, and mitigation strategies
- Prepare scientific reviews, briefing materials, technical memoranda, and regulatory recommendations for FDA leadership and multidisciplinary review teams
- Provide objective, well-supported scientific interpretations to support regulatory decision making
Minimum Qualifications:
EducationBachelor of Science degree or higher in Biomedical Engineering from an ABET-accredited engineering program. ORBachelor 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 management Experience working with clinical staff regarding the safety, effectiveness, performance, and operational use of medical devices Experience 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 assessment
- Post market surveillance programs
- Medical device adverse event reporting and analysis
- Recall management and corrective actions
- Medical device incident investigation
- Root cause analysis
- Medical device forensics
- Failure Mode and Effects Analysis (FMEA)
- Hazard mitigation and risk management
- Signal detection, evaluation, and management
Preferred Skills:
- Strong analytical and critical thinking skills with the ability to evaluate complex scientific, engineering, and healthcare related information
- Ability to synthesize information from multiple sources and stakeholders in an objective and unbiased manner
- Demonstrated initiative in identifying additional data, context, and insights that support informed decision making
- Excellent written and verbal communication skills
- Ability to prepare professional reports, presentations, and regulatory review documents
- Strong interpersonal and collaboration skills
- Experience leading stakeholder engagement and outreach activities
- Proficiency 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.
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