About This Role:We are seeking a Product Security Manager with proven experience in the medical device industry. In this role, you will safeguard medical devices by identifying, assessing, and mitigating security risks unique to healthcare technology. You will collaborate with cybersecurity, development, product management, and regulatory teams to ensure that security is embedded across the product development lifecycle (PDLC) and the secure software development lifecycle (SDLC), in alignment with FDA cybersecurity requirements.
Key Responsibilities- FDA Cybersecurity Compliance: Ensure compliance with FDA cybersecurity guidance and regulations in collaboration with Cybersecurity, Regulatory, Quality, and Systems Development teams.
- Risk Assessments & CSRAs: Conduct comprehensive security risk assessments, including Cybersecurity Risk Assessments (CSRAs), to identify vulnerabilities and threats across device hardware, firmware, software, and cloud components.
- Threat Modeling: Develop and maintain device-specific cyber threat models, factoring in patient safety, data privacy, and operational continuity.
- SBOM Management: Demonstrate familiarity with Software Bill of Materials (SBOM) and effectively communicate technical details.
- Security Documentation: Create and maintain cybersecurity documentation for pre- and post-market activities, ensuring regulatory alignment.
- Data Flow Diagrams: Produce detailed data flow diagrams to support the threat modeling process.
- Security Design Reviews: Participate in design reviews of medical device architectures and implementations, providing actionable recommendations for system security requirements.
- Vulnerability Analysis & Management: Perform and support vulnerability analysis and coordinate the vulnerability management program, including scanning, patching, and remediation for medical devices.
- Threat Detection Tools: Leverage and maintain application and threat detection tools (Veracode, Snyk, GitLab, or equivalent) to identify security flaws early in the SDLC.
- Incident Response: Support investigation and remediation of device-related security incidents, minimizing impact and preventing recurrence.
- Data Privacy Compliance: Partner with the Privacy Team to ensure adherence to HIPAA, GDPR, and other data protection regulations.
Required Qualifications- 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.
Preferred Qualifications- 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.
Location:Remote - US
Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
Estimated Pay Range$127,000.00 - $165,000.00
