Biomedical Engineer (Ultrasound / Mechanical)
About The Position
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.
Requirements
- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Acoustics, Ultrasound Engineering, or a closely related scientific or engineering discipline.
- At least 5 years of relevant professional experience in biomedical engineering, acoustics, ultrasonics, medical devices, or a closely related field.
- Demonstrated expertise in acoustics, ultrasonics, or medical ultrasound technologies.
- Experience with medical device research and development, testing, validation, regulatory affairs, clinical evaluation, or sustaining engineering.
- Strong analytical, problem-solving, and technical writing skills.
- Exceptional written and verbal communication skills.
- Ability to explain complex scientific and engineering concepts to multidisciplinary audiences.
- Ability to work independently and effectively as part of multidisciplinary technical teams.
- Proficiency with Microsoft Office applications.
- Must be US Citizen or full Green Card holder.
Nice To Haves
- Advanced degree (MS or PhD) in a relevant discipline is strongly preferred.
- Experience with medical device regulatory review or direct support of FDA submissions is preferred.
- Advanced training or research experience in acoustics, ultrasound physics, biomedical instrumentation, or therapeutic ultrasound.
- Experience with acoustic measurement systems and ultrasound test methodologies.
- Experience with computational modeling and simulation of ultrasound fields.
- Experience evaluating ultrasound tissue interactions or biological effects.
- Experience with medical device risk management.
- Experience supporting FDA regulatory submissions or regulatory science activities.
- Experience evaluating novel or emerging medical device technologies.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
