Product Cybersecurity Engineer (Medical Devices)

Analog Devices, Inc.; Wilmington (MA); On-site; USD 134,644 - 201,966; Full time

Benefits offered by this job

Medical coverage

Vision coverage

Dental coverage

401k

Paid vacation

Holidays

Sick time

Job summary

Analog Devices, Inc. is seeking a Product Cybersecurity Engineer for Medical Devices to lead cybersecurity across the product lifecycle, focusing on threat modeling, risk management, and regulatory compliance for SaMD.

The role requires collaboration with cross‑functional teams to drive secure design, architecture reviews, and documentation supporting FDA regulatory submissions, including 510(k) activities.

Qualifications

• Master’s or Ph.D. in Cybersecurity or related technical discipline; Ph.D. preferred.
• 7+ years in cybersecurity, product security, or related engineering roles.
• Experience with medical devices, SaMD, or FDA-regulated products.
• Experience supporting FDA regulatory submissions, incl. 510(k).
• Proficiency in threat modeling (STRIDE, attack trees, misuse cases).
• Ability to define security controls and mitigation strategies.
• Familiarity with NIST CSF, ISO 14971, IEC 62304, OWASP guidance.
• Experience with SBOM, third‑party software risk, and SDL/SSDLC.
• Strong writing, communication, and cross‑functional skills.

Responsibilities

• Perform product security risk assessments and threat modeling for medical devices and SaMD.
• Lead cybersecurity risk management across the product lifecycle per FDA guidance.
• Support cybersecurity documentation for FDA submissions and SBOMs.
• Conduct security architecture reviews against secure principles and regulatory expectations.
• Maintain cybersecurity risk management, vulnerability management, and incident response processes.
• Collaborate with internal/external teams to embed secure-by-design practices.
• Contribute to SDL/SSDLC activities including design reviews and verification.
• Analyze results from vulnerability assessments and penetration testing.

Skills

Cybersecurity

Medical devices

Threat modeling

Risk management

Regulatory compliance

FDA submissions

Secure SDLC

Vulnerability management

Threat analysis

Cross-functional collaboration

Education

Master’s or Ph.D. in Cybersecurity/CS/CE/SE

Tools

SBOM tooling

Vulnerability scanners

Job description

## Product Cybersecurity Engineer (Medical Devices)Applylocations: US, MA, Wilmingtontime type: Full timeposted on: Posted Todayjob requisition id: R263547**About Analog Devices**Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and software technologies into solutions that combat climate change, reliably connect humans and the world, and help drive advancements in automation and robotics, mobility, healthcare, energy and data centers. With revenue of more than $11 billion in FY25, ADI ensures today's innovators stay Ahead of What's Possible. Learn more at www.analog.com and on LinkedIn and X.**Product Cybersecurity Engineer – Medical Devices**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.**Key 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.**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.**Additional Desired Skills and Qualifications*** 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.*For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this position – except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) – may have to go through an export licensing review process.**Analog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.**EEO is the Law: Notice of Applicant Rights Under the Law.*Job Req Type: ExperiencedRequired Travel: Yes, 10% of the timeShift Type: 1st Shift/DaysThe expected wage range for a new hire into this position is $134,644 to $201,966.* Actual wage offered may vary depending on work location, experience, education, training, external market data, internal pay equity, or other bona fide factors.* This position qualifies for a discretionary performance-based bonus which is based on personal and company factors.* This position includes medical, vision and dental coverage, 401k, paid vacation, **holidays, and sick time**, and other benefits.