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iRhythm Technologies, Inc. · 1 week ago

Product Security Manager

iRhythm Technologies, Inc. is a leading digital healthcare company focused on providing innovative cardiac health solutions. They are seeking a Product Security Manager to ensure the protection of patient data and device integrity while ensuring compliance with regulatory requirements throughout the product lifecycle.
HealthcareMedical DeviceElectronicsHealth CareHealth DiagnosticsmHealthWearables
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H1B Sponsor Likelynote

Responsibilities

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

Qualification

Product SecurityMedical Device SecurityFDA Cybersecurity ComplianceCybersecurity Risk Assessments (CSRAs)Threat ModelingSoftware Bill of Materials (SBOM)Security DocumentationData Flow DiagramsSecurity Design ReviewsVulnerability AnalysisVulnerability ManagementThreat Detection ToolsVeracodeSnykGitLabIncident ResponseData Privacy ComplianceHIPAAGDPRNIST Cybersecurity FrameworkNIST SP 800-171NIST SP 800-53NIST SP 800-92NIST SP 800-63STRIDE MethodologyRegulated Environment ComplianceSoftware as a Medical Device (SaMD)Medical Device Software Development510(k) SubmissionsCISSP

Required

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

Preferred

Industry certifications such as CISSP, CISM, CISA, or medical device security–specific certifications
Experience with international frameworks and standards (EU MDR, JIS T 2304 / IEC 62304)
Understanding penetration testing methodologies and tools, able to work with pen test teams independently with little guidance
Proficiency with programming languages and technologies commonly used in medical device development

Company

iRhythm Technologies, Inc.

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iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease.

H1B Sponsorship

iRhythm Technologies, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
81%
Represents job field similar to this job
Engineering and Development
Legal and Compliance
Customer Service and Support
Management and Executive
Product Management
Accounting and Finance
Trends of Total Sponsorships
*2026 (2)
2025 (9)
2024 (13)
2023 (10)
2022 (9)
2021 (16)
2020 (11)

Funding

Current Stage
Public Company
Total Funding
$1.19B
Key Investors
BraidwellNovo HoldingsNorwest
2024-03-04Post Ipo Debt· $643.6M
2020-08-21Post Ipo Secondary· $220M
2019-09-11Post Ipo Equity· $115M

Leadership Team

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Quentin Blackford
Chief Executive Officer
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Mark Day
Chief Technology Officer
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Company data provided by crunchbase