Biomedical Engineer; Ultrasound​/Mechanical

BIOMEDICAL ENGINEER SUBJECT MATTER EXPERT

Employment Type:

Full-Time

Schedule:

Monday–Friday, excluding holidays

Location:

Silver Spring, MD

The FDA Center for Devices and Radiological Health (CDRH) seeks an experienced Biomedical Engineer Subject Matter Expert (SME) with specialized expertise in acoustics and/or ultrasonics to provide scientific, engineering, regulatory science, and technical support for the evaluation of medical devices.

The SME will support regulatory review, regulatory science research, laboratory and computational analyses, and technical consultation involving diagnostic and therapeutic ultrasound technologies. Areas of particular interest include transcranial ultrasound, high-intensity focused/therapeutic ultrasound (HIFU/HITU), ultrasound metrology, acoustic output measurement, signal processing, tissue characterization, ultrasound neuromodulation, blood-brain barrier (BBB) opening, and histotripsy.

The position will provide expert technical input on the safety, performance, design, development, testing, and validation of ultrasound-based medical devices and will support evaluation of emerging technologies and complex regulatory issues.

• Provide biomedical engineering expertise, with emphasis on acoustics and ultrasonics, in support of CDRH regulatory and scientific activities.
• Provide consultation on diagnostic and therapeutic ultrasound devices, including transcranial and other advanced ultrasound technologies.
• Support review of premarket submissions, including 510(k) s, PMAs, IDEs, De Novo requests, EUAs, combination products, and Pre-Submissions, as applicable.
• Evaluate device design, acoustic performance, safety, testing, validation, and technical documentation.
• Conduct or support regulatory science laboratory research and computational analyses involving ultrasound technologies.
• Apply expertise in ultrasound physics, acoustic measurement and metrology, signal processing, tissue characterization, and computational modeling to address complex scientific and regulatory questions.
• Evaluate emerging therapeutic ultrasound applications, including neuromodulation, BBB opening, histotripsy, HIFU/HITU, and transcranial ultrasound.
• Review test reports, engineering analyses, validation data, computational models, and other technical documentation.
• Support investigation of device failures, performance concerns, adverse technical findings, and other issues involving marketed devices.
• Provide technical input regarding device safety, risk assessment, performance characterization, and benefit-risk considerations.
• Prepare technical reviews, scientific assessments, reports, correspondence, presentations, and regulatory recommendations.
• Participate in multidisciplinary meetings and communicate complex technical findings to scientific, clinical, engineering, and regulatory personnel.
• Provide technical expertise regarding applicable FDA requirements, guidance documents, and consensus standards.

The candidate should be familiar with applicable FDA regulations, guidance documents, and recognized consensus standards relevant to medical ultrasound and medical device evaluation, including, as appropriate:

• FDA guidance concerning the Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.
• FDA-recognized consensus standards applicable to ultrasound equipment, acoustic output, acoustic measurement, safety, performance, and testing.
• 21 CFR Part 820 – Quality System Regulation, as applicable to device design, manufacturing, and quality systems.
• ANSI/AAMI/ISO 14971 – Medical Devices – Application of Risk Management to Medical Devices.
• Applicable FDA requirements and guidance concerning…