Biomedical Engineer – Diagnostic Ultrasound

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🕒 Ontem

🦀 Maryland – Remoto

🦀 Maryland – Remote

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👷🏻‍♀️ Engenheiro

👻 Score fantasma 12%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Tunnell Consulting, Inc.

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51 - 200 funcionários

Fundada em 1962

🏛️ Governo

🏥 Saúde

💼 Consultoria

Government • Healthcare • Consulting

A Tunnell Consulting, Inc. é uma empresa de consultoria e serviços com foco no governo, que oferece expertise científica, técnica e em gestão de projetos para agências federais. As soluções da empresa (sob a marca Tunnell Government Services) são voltadas à preparação e à resposta em saúde pública — ajudando a proteger os Estados Unidos contra grandes ameaças à saúde — e à gestão estratégica de portfólios de projetos científicos em todas as fases de P&D, incluindo o desenvolvimento de produtos médicos e a supervisão de portfólios. A empresa também oferece soluções de staffing para apoiar clientes governamentais e transformar organizações para que cumpram suas missões institucionais.

Descrição

• 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 supporting scientific documentation • Support postmarket surveillance and compliance activities, including evaluation of MDRs, recalls, EIRs, 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 FDA regulations, guidance documents, consensus standards, and quality system principles • Collaborate with multidisciplinary teams of engineers, scientists, clinicians, and regulatory professionals

🎯 Requisitos

• 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 • Preferred: advanced degree (M.S., Ph.D., or equivalent) in a related field • Preferred: advanced training, research, or specialized expertise in acoustics, ultrasound physics, biomedical instrumentation, therapeutic ultrasound, or imaging science • Preferred: experience evaluating innovative, emerging, or novel medical device technologies • Preferred: experience developing clinical evaluation strategies, performance testing plans, or clinical study protocols for medical devices • Preferred: knowledge of medical device risk management principles and methodologies • Preferred: experience 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

🏖️ Benefícios

• Full-time employee position • 100% telework / fully remote work arrangement • Employee-owned company • Monday–Friday schedule, excluding holidays

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