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 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 Review

Review 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

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 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.