Product Cybersecurity Engineer (Medical Devices)

Analog Devices•Wilmington, MA

1d•$134,644 - $201,966•Onsite

About The Position

The Health Solutions Business Unit at Analog Devices is seeking a Product Cybersecurity Engineer to lead cybersecurity activities across the medical device product lifecycle. This role focuses on ensuring the security, privacy, and regulatory compliance of connected medical devices and Software as a Medical Device (SaMD) solutions. The candidate will collaborate with internal and external teams to drive cybersecurity risk management activities, secure product design, threat modeling, vulnerability management, and cybersecurity compliance throughout the product lifecycle, from concept and development through post-market support. A significant portion of this role involves performing threat modeling and supporting cybersecurity risk management activities aligned with FDA cybersecurity guidance. The successful candidate will also contribute to cybersecurity documentation supporting FDA regulatory submissions, including 510(k) activities, while helping to establish and maintain post-market cybersecurity processes and secure development lifecycle (SDL) practices for regulated medical devices.

Requirements

Master’s or Ph.D. degree in Cybersecurity, Computer Science, Computer Engineering, Software Engineering, or a related technical discipline. Ph.D. preferred.
7+ years of experience in cybersecurity, product security, software security, or related engineering roles.
Experience supporting cybersecurity activities for medical devices, connected healthcare products, or Software as a Medical Device (SaMD).
Demonstrated experience supporting FDA-regulated medical devices, including 510(k) submissions.
Demonstrated experience performing threat modeling for complex systems using methodologies such as STRIDE, attack trees, misuse cases, or equivalent frameworks.
Experience defining security controls, cybersecurity requirements, and mitigation strategies based on identified threats and risks.
Familiarity with cybersecurity standards and frameworks such as NIST Cybersecurity Framework, ISO 14971, IEC 62304, AAMI TIR57, and OWASP guidance.
Experience with vulnerability management, security testing, penetration testing, and remediation processes.
Familiarity with Software Bill of Materials (SBOM), third-party software risk management, and supply chain cybersecurity concepts.
Experience integrating cybersecurity requirements into Secure Development Lifecycle (SDL/SSDLC) processes.
Strong analytical, technical writing, communication, and cross-functional collaboration skills.

Nice To Haves

Experience with connected medical devices, SaMD, cloud-connected platforms, or AI/ML-enabled medical products.
Experience with post-market cybersecurity monitoring, vulnerability disclosure, and incident response processes.
Experience with connected medical devices, cloud-connected platforms, IoMT, or digital health solutions.
Professional certifications such as CISSP, CSSLP, HCISPP, GICSP, Security+, or equivalent.

Responsibilities

Perform product security risk assessments and threat modeling for medical devices and SaMD platforms.
Lead cybersecurity risk management activities throughout the product lifecycle in alignment with FDA guidance and industry best practices.
Support cybersecurity documentation for FDA regulatory submissions, including cybersecurity risk management files, SBOM requirements, and other regulatory deliverables.
Conduct security architecture reviews and evaluate system designs against secure architecture principles, cybersecurity frameworks, and regulatory expectations.
Develop and maintain cybersecurity risk management documentation, vulnerability management processes, and incident response procedures.
Partner with internal and external teams to integrate secure-by-design principles into product development and lifecycle management activities.
Participate in secure development lifecycle (SDL/SSDLC) activities, including security requirements definition, design reviews, and cybersecurity verification activities.
Analyze results from vulnerability assessments, static analysis, dynamic analysis, penetration testing, and security scanning activities.
Support SBOM generation, third-party software assessments, and supply chain cybersecurity risk evaluations.
Investigate and support remediation of cybersecurity vulnerabilities affecting medical devices, software platforms, and connected product ecosystems.
Participate in vulnerability management, coordinated vulnerability disclosure, product security incident response, and post-market cybersecurity monitoring activities.
Support internal audits, external assessments, FDA inspections, and cybersecurity reviews related to medical device security and regulatory compliance.
Serve as a cybersecurity subject matter expert (SME) for cross-functional teams and product cybersecurity initiatives.