Remote Biomedical Engineer - Diagnostic Ultrasound SME

Tunnell Government Services, Inc.; United States; Remote; 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

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.