Biomedical Engineer (Ultrasound / Mechanical) - Hybrid role

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BIOMEDICAL ENGINEER SUBJECT MATTER EXPERT

Acoustics / Ultrasonics

Employment Type: Full-Time
Schedule: Monday-Friday, excluding holidays
Location: Silver Spring, MD - Hybrid position

Position Summary

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.

Key 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.

Relevant FDA Regulations, Guidances, and 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 medical device design, verification and validation, premarket review, and post-market evaluation.
• Applicable IEC, ISO, AIUM, NEMA, and other consensus standards addressing medical ultrasound, acoustic output, measurement methods, safety, and performance.

The candidate should be capable of assessing the appropriateness of applicable standards and test methods and determining whether submitted technical evidence adequately supports the safety and performance of the device.

Desired Technical Expertise

Preference will be given to candidates with substantial expertise in one or more of the following:

• Acoustics and ultrasound physics.
• Transcranial ultrasound.
• High-intensity focused or therapeutic ultrasound.
• Ultrasound metrology and acoustic output measurement.
• Ultrasound signal processing.
• Ultrasonic materials and tissue characterization.
• Ultrasound neuromodulation.
• Ultrasound-mediated blood-brain barrier opening.
• Histotripsy.
• Medical ultrasound instrumentation and bioinstrumentation.
• Ultrasound safety and performance evaluation.
• Computational modeling of ultrasound fields or device performance.
• Medical device testing and validation.
• Regulatory science involving ultrasound technologies.

Qualifications

• 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.
• Advanced degree (MS or PhD) in a relevant discipline is strongly preferred.
• 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.
• Experience with medical device regulatory review or direct support of FDA submissions is preferred.
• 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.

Preferred Additional Experience

Preference may be given to candidates with:

• 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.

Expected Deliverables

The SME may develop or contribute to:

• Technical and regulatory reviews of medical device submissions.
• Scientific and engineering assessments.
• Ultrasound safety and performance evaluations.
• Reviews of acoustic output and measurement data.
• Laboratory and computational research analyses.
• Technical assessments of device failures and performance concerns.
• Written consultation memoranda, reports, and regulatory correspondence.
• Technical recommendations and responses to regulatory review questions.
• Meeting materials, presentations, and technical briefings.

Position Objective

The primary objective of this position is to provide specialized biomedical engineering, acoustics, ultrasonics, and regulatory science expertise to support CDRH's evaluation of diagnostic and therapeutic ultrasound technologies.

The SME will apply advanced engineering and scientific knowledge to independently evaluate complex device designs, acoustic performance, testing, computational analyses, and safety data; conduct or interpret laboratory and computational research; and provide scientifically sound recommendations to support timely, consistent, and risk-based regulatory decision-making.

The position will strengthen CDRH's technical capacity to evaluate emerging ultrasound technologies and address complex scientific and engineering issues associated with their safety and effectiveness.

Must be 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.