Product Security Manager

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🔥 16 hours ago

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iRhythm Technologies, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2006

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare Insurance • Biotechnology • Medical Technology

iRhythm Technologies, Inc. is a medical technology company that specializes in digital healthcare solutions for the management of cardiac arrhythmias. The company is best known for its ZioSuite, a comprehensive platform designed to deliver a streamlined solution for assessing heart health through advanced analytics and patient-centered data collection. iRhythm focuses on improving patient outcomes and optimizing the efficiency of healthcare providers through innovative technology in the cardiac monitoring space.

📋 Description

• 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.

🎯 Requirements

• Bachelor’s degree in Computer Science, Information Security, or related field. • 8+ 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. • Proven track record of 510k experience and completion.

🏖️ Benefits

• Reasonable accommodations for qualified individuals with disabilities in job application procedures