Biomedical Engineer Jobs

About The Position

Requirements

• Bachelor's degree (B.S.) in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Physics, Acoustics, Medical Physics, or a closely related technical discipline.
• Minimum of five (5) years of professional experience in biomedical engineering, ultrasound technology, acoustics, ultrasonics, medical devices, or a related field.
• Demonstrated research, development, or technical evaluation experience involving medical imaging devices and associated software.
• Experience 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 utilized in medical imaging applications, particularly within ultrasound or radiological imaging environments.
• Strong technical writing and communication skills, with the ability to prepare clear and well-supported scientific assessments and regulatory reviews.
• Must be a US Citizen or full Green Card holder.

Nice To Haves

• Advanced degree (M.S., Ph.D., or equivalent) in Biomedical Engineering, Physics, Acoustics, Medical Physics, Computer Engineering, or a related field.
• Advanced training, research, or specialized expertise in acoustics, ultrasound physics, biomedical instrumentation, therapeutic ultrasound, or imaging science.
• Experience evaluating innovative, emerging, or novel medical device technologies.
• Experience developing clinical evaluation strategies, performance testing plans, or clinical study protocols for medical devices.
• Knowledge of medical device risk management principles and methodologies.
• Experience supporting FDA-regulated medical devices in areas such as premarket review, quality systems, regulatory affairs, compliance, or postmarket surveillance.
• Familiarity with FDA-recognized consensus standards, guidance documents, and regulatory frameworks related to: Diagnostic ultrasound systems, Medical imaging devices, Software as a Medical Device (SaMD), Artificial intelligence and machine learning-enabled devices, Radiation-emitting products, Cybersecurity for medical devices.

Responsibilities

• Conduct comprehensive technical and scientific reviews of medical device submissions, including 510(k), PMA, Pre-IDE, IDE, De Novo, and 513(g) submissions.
• Evaluate diagnostic ultrasound systems, associated software, and related technologies for safety, effectiveness, performance, and clinical utility.
• Provide subject matter expertise in ultrasound physics, acoustic output, imaging performance, and clinical applications of diagnostic ultrasound.
• Assess device design, engineering documentation, acoustic performance, software functionality, testing methodologies, validation activities, and risk management documentation.
• Review technical reports, engineering analyses, verification and validation data, computational modeling studies, and other supporting scientific documentation.
• Support postmarket surveillance and compliance activities, including evaluation of Medical Device Reports (MDRs), recalls, Establishment Inspection Reports (EIRs), Electronic Product Radiation Control (EPRC) issues, and trade complaints.
• Investigate device performance concerns, adverse events, technical deficiencies, and reported product failures involving marketed devices.
• Provide scientific and technical recommendations regarding device safety, risk assessment, benefit-risk determinations, and regulatory decision-making.
• Prepare written technical reviews, scientific assessments, memoranda, presentations, correspondence, and regulatory recommendations.
• Interpret and apply applicable FDA regulations, guidance documents, consensus standards, and quality system principles to support regulatory evaluations and policy implementation.
• Collaborate with multidisciplinary teams of engineers, scientists, clinicians, and regulatory professionals to address complex medical device issues.

Benefits

• Employee-owned company
• Innovative, integrated and differentiated solutions