Biomedical Engineer - Diagnostic Ultrasound

Tunnell Government Services, Inc.; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Tunnell Government Services, Inc. is seeking a Medical Device Reviewer/Biomedical Engineer – Diagnostic Ultrasound to support FDA submissions from a fully remote position in the United States.

The role requires deep expertise in ultrasound physics, imaging performance, and regulatory review across various submission types. The ideal candidate will have 5+ years in biomedical engineering or ultrasound tech, strong technical writing, and familiarity with AI/ML in medical imaging.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Physics, Acoustics, Medical Physics, or related field.
• Minimum of five (5) years of professional experience in biomedical engineering, ultrasound tech, acoustics, or related field.
• Experience with medical imaging devices and associated software development, testing, validation, or evaluation.
• Experience supporting ultrasound hardware/software development and evaluation.
• Experience with AI/ML technologies in medical imaging, especially ultrasound or radiology.
• Strong technical writing and communication skills for regulatory reviews.

Responsibilities

• Conduct comprehensive technical and scientific reviews of medical device submissions (510(k), PMA, IDE, De Novo, etc).
• Evaluate diagnostic ultrasound systems, software, and related technologies for safety and performance.
• Provide SME input on ultrasound physics, acoustic output, imaging performance, and clinical applications.
• Assess device design, engineering documentation, acoustic performance, software, testing methodologies, and risk management.
• Review technical reports, validation data, computational modeling, and other supporting documentation.
• Support postmarket surveillance, MDRs, recalls, EIRs, EPRC issues, and trade complaints.
• Investigate device performance concerns and reported failures.
• Provide regulatory recommendations on safety, risk, and benefit-risk determinations.
• Prepare technical reviews, memoranda, and regulatory correspondence.
• Interpret FDA regulations, guidance, standards, and QMS principles for evaluations.

Skills

Technical writing

Communication skills

AI/ML in imaging

Education

Bachelor’s degree in Biomedical Engineering or related

Advanced degree (MS/PhD) preferred

Tools

AI/ML in medical imaging

Job description

Biomedical Engineer – Diagnostic Ultrasound Position Description

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.

Position Title:

Medical Device Reviewer/Biomedical Engineer – Diagnostic Ultrasound Subject Matter Expert (SME)

Employment Type: Full-Time Employee

Schedule: Monday-Friday, excluding holidays

Location: 100% Telework

Medical Device Reviewer/Biomedical Engineer - Diagnostic Ultrasound

Full-Time Remote Contractor

The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Radiological Health, Division of Radiological Imaging and Radiation Therapy Devices (DHT8C) is seeking a highly qualified professional to provide technical and regulatory expertise in the review of diagnostic ultrasound and medical imaging device submissions. This full-time, fully remote contractor position supports the FDA’s mission to ensure the safety, effectiveness, and quality of medical devices throughout their product lifecycle.

Key Responsibilities

• Conduct comprehensive technical and scientific reviews of medical device submissions, including 510(k), PMA, Pre-IDE, IDE, De Novo, and 513(g) submissions.
• Evaluate diagnostic ultrasound systems, associated software, and related technologies for safety, effectiveness, performance, and clinical utility.
• Provide subject matter expertise in ultrasound physics, acoustic output, imaging performance, and clinical applications of diagnostic ultrasound.
• Assess device design, engineering documentation, acoustic performance, software functionality, testing methodologies, validation activities, and risk management documentation.
• Review technical reports, engineering analyses, verification and validation data, computational modeling studies, and other supporting scientific documentation.
• Support postmarket surveillance and compliance activities, including evaluation of Medical Device Reports (MDRs), recalls, Establishment Inspection Reports (EIRs), Electronic Product Radiation Control (EPRC) issues, and trade complaints.
• Investigate device performance concerns, adverse events, technical deficiencies, and reported product failures involving marketed devices.
• Provide scientific and technical recommendations regarding device safety, risk assessment, benefit-risk determinations, and regulatory decision-making.
• Prepare written technical reviews, scientific assessments, memoranda, presentations, correspondence, and regulatory recommendations.
• Interpret and apply applicable FDA regulations, guidance documents, consensus standards, and quality system principles to support regulatory evaluations and policy implementation.
• Collaborate with multidisciplinary teams of engineers, scientists, clinicians, and regulatory professionals to address complex medical device issues.

Required Qualifications

• Bachelor’s degree (B.S.) in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Physics, Acoustics, Medical Physics, or a closely related technical discipline.
• Minimum of five (5) years of professional experience in biomedical engineering, ultrasound technology, acoustics, ultrasonics, medical devices, or a related field.
• Demonstrated research, development, or technical evaluation experience involving medical imaging devices and associated software.
• Experience supporting the research, development, testing, validation, or evaluation of diagnostic ultrasound hardware and/or software systems.
• Experience with artificial intelligence (AI) and machine learning technologies utilized in medical imaging applications, particularly within ultrasound or radiological imaging environments.
• Strong technical writing and communication skills, with the ability to prepare clear and well-supported scientific assessments and regulatory reviews.

Preferred Qualifications

• Advanced degree (M.S., Ph.D., or equivalent) in Biomedical Engineering, Physics, Acoustics, Medical Physics, Computer Engineering, or a related field.
• Advanced training, research, or specialized expertise in acoustics, ultrasound physics, biomedical instrumentation, therapeutic ultrasound, or imaging science.
• Experience evaluating innovative, emerging, or novel medical device technologies.
• Experience developing clinical evaluation strategies, performance testing plans, or clinical study protocols for medical devices.
• Knowledge of medical device risk management principles and methodologies.
• Experience supporting FDA-regulated medical devices in areas such as premarket review, quality systems, regulatory affairs, compliance, or postmarket surveillance.
• Familiarity with FDA-recognized consensus standards, guidance documents, and regulatory frameworks related to:
  • Diagnostic ultrasound systems
  • Medical imaging devices
  • Software as a Medical Device (SaMD)
  • Artificial intelligence and machine learning-enabled devices
  • Radiation-emitting products
  • Cybersecurity for medical devices

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.