Senior Product Security Engineer

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iRhythm Technologies, Inc.

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1001 - 5000 funcionários

Fundada em 2006

⚕️ Seguro de Saúde

🧬 Biotecnologia

Healthcare Insurance • Biotechnology • Medical Technology

A iRhythm Technologies, Inc. é uma empresa de tecnologia em saúde que se especializa em soluções de monitoramento cardíaco. Seu produto principal, o monitor Zio ECG, é projetado para o conforto e aderência do paciente, permitindo que os profissionais de saúde forneçam diagnósticos precisos de arritmias através de análise avançada de dados e inteligência artificial. O serviço abrangente da iRhythm transforma a experiência de monitoramento cardíaco, facilitando melhores resultados para os pacientes e fluxos de trabalho eficientes para profissionais de saúde em todo o mundo.

Descrição

• Ensure compliance with FDA cybersecurity guidance and regulations in collaboration with Cybersecurity, Regulatory, Quality, and Systems Development teams. • Conduct comprehensive security risk assessments, including Cybersecurity Risk Assessments (CSRAs), to identify vulnerabilities and threats across device hardware, firmware, software, and cloud components. • Develop and maintain device-specific cyber threat models, factoring in patient safety, data privacy, and operational continuity. • Demonstrate familiarity with Software Bill of Materials (SBOM) and effectively communicate technical details. • Create and maintain cybersecurity documentation for pre- and post-market activities, ensuring regulatory alignment. • Produce detailed data flow diagrams to support the threat modeling process. • Participate in design reviews of medical device architectures and implementations, providing actionable recommendations for system security requirements. • Perform and support vulnerability analysis and coordinate the vulnerability management program, including scanning, patching, and remediation for medical devices. • Leverage and maintain application and threat detection tools (Veracode, Snyk, GitLab, or equivalent) to identify security flaws early in the SDLC. • Support investigation and remediation of device-related security incidents, minimizing impact and preventing recurrence. • Partner with the Privacy Team to ensure adherence to HIPAA, GDPR, and other data protection regulations.

🎯 Requisitos

• Bachelor’s degree in Computer Science, Information Security, or related field. • 6+ years of experience in information security, with direct focus on product security for medical devices. • Strong understanding of security principles, methodologies, and tools within the PDLC and SDLC. • Demonstrated experience conducting Cybersecurity Risk Assessments (CSRAs), vulnerability analysis, and working with modern threat detection tools (Veracode, Snyk, GitLab, or similar). • Familiarity with NIST Cybersecurity Framework, NIST SP 800-171, and deeper controls/frameworks such as NIST SP 800-53 (Security and Privacy Controls), NIST SP 800-92 (Log Management), and NIST SP 800-63 (Digital Identity Guidelines). • Hands-on experience with vulnerability identification and threat modeling within healthcare using methodologies such as STRIDE. • Experience operating in a regulated environment (FDA, HIPAA, GDPR, international regulatory frameworks). • Experience with medical device hardware or Software as a Medical Device (SaMD). • Experience with medical device software development and regulatory processes. • Excellent problem-solving, analytical, and communication skills, able to take a multi-siloed approach. • Ability to understand intro dependencies of teams across; mobile applications, hardware and cloud environments. • Demonstrated experience supporting 510(k) submissions, with a focus on product security documentation, risk assessments, and regulatory compliance.

🏖️ Benefícios

• Health insurance • 401(k) matching • Flexible work hours • Professional development opportunities