Biomedical Engineer – Diagnostic Ultrasound

This is a fully remote position, open to applicants in Maryland.

📋 Description

• Perform thorough technical and scientific evaluations of medical device submissions, including 510(k), PMA, Pre-IDE, IDE, De Novo, and 513(g) submissions.

• Assess diagnostic ultrasound systems, their associated software, and related technologies for safety, effectiveness, performance, and clinical utility.

• Offer subject matter expertise in ultrasound physics, acoustic output, imaging performance, and clinical applications of diagnostic ultrasound.

• Evaluate device design, engineering documentation, acoustic performance, software functionality, testing methodologies, validation activities, and risk management documentation.

• Analyze technical reports, engineering analyses, verification and validation data, computational modeling studies, and supporting scientific documentation.

• Assist with postmarket surveillance and compliance activities, including the review of MDRs, recalls, EIRs, EPRC issues, and trade complaints.

• Investigate device performance issues, adverse events, technical deficiencies, and reported product failures related to marketed devices.

• Provide scientific and technical recommendations concerning device safety, risk assessment, benefit-risk determinations, and regulatory decision-making.

• Draft written technical reviews, scientific assessments, memoranda, presentations, correspondence, and regulatory recommendations.

• Interpret and apply FDA regulations, guidance documents, consensus standards, and quality system principles.

• Collaborate with multidisciplinary teams of engineers, scientists, clinicians, and regulatory professionals.

⛳️ Requirements

• Bachelor's degree (B.S.) in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Physics, Acoustics, Medical Physics, or a closely related technical discipline.

• At least five (5) years of professional experience in biomedical engineering, ultrasound technology, acoustics, ultrasonics, medical devices, or a related field.

• Proven experience in research, development, or technical evaluation involving medical imaging devices and related software.

• Familiarity with 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 applied in medical imaging, particularly in ultrasound or radiological imaging contexts.

• Excellent technical writing and communication skills, with the capability to produce clear and well-supported scientific assessments and regulatory reviews.

• Must be a US Citizen or a full Green Card holder.

• Preferred: advanced degree (M.S., Ph.D., or equivalent) in a relevant field.

• Preferred: advanced training, research, or specialized knowledge in acoustics, ultrasound physics, biomedical instrumentation, therapeutic ultrasound, or imaging science.

• Preferred: experience in evaluating innovative, emerging, or novel medical device technologies.

• Preferred: experience in developing clinical evaluation strategies, performance testing plans, or clinical study protocols for medical devices.

• Preferred: understanding of medical device risk management principles and methodologies.

• Preferred: experience in supporting FDA-regulated medical devices in premarket review, quality systems, regulatory affairs, compliance, or postmarket surveillance.

• Preferred: familiarity with FDA-recognized consensus standards, guidance documents, and regulatory frameworks related to diagnostic ultrasound systems, medical imaging devices, SaMD, AI/ML-enabled devices, radiation-emitting products, and medical-device cybersecurity.

🏝️ Benefits

• Full-time employee position.

• 100% telework / fully remote work arrangement.

• Employee-owned company.

• Monday–Friday schedule, excluding holidays.