Information Security Risk & Compliance Analyst at AAB focusing on ISO 27001 compliance and information security management. Collaborating across teams to ensure robust risk and compliance frameworks.
About the role
- Senior Product Security Engineer at Johnson & Johnson ensuring robust security for medical devices. Implementing security architectures and managing risks across the product lifecycle in healthcare innovation.
Responsibilities
- The Senior Product Security Engineer will be responsible for implementation of J&J’s enterprise Product Security strategy and framework throughout the Heart Recovery portfolio of medical devices and supporting platforms.
- This role will join Abiomed, part of Johnson & Johnson MedTech, to provide technical expertise and strategic leadership in securing Impella heart pump technologies, next-generation cardiac support systems, and connected medical devices.
- This role is responsible for delivering security architecture, cryptographic controls, embedded system protections/controls, and threat mitigation techniques to ensure robust, regulatory-compliant security across the product lifecycle.
- Specific responsibilities include supporting heart recovery throughout a new product’s development phases, review product security requirements and recommend security design solutions, complete Quality documentation, threat modelling, coordinate third-party penetration testing, software architecture review and design recommendations, code analysis and other security testing work as needed.
- Additionally, this position will have post market responsibilities for Heart Recovery marketed devices include monitoring for new vulnerabilities, assisting with patching and remediation plans, as well as responding to customer security questionnaires and reviewing security language within contractual agreements as needed.
- Drive alignment to J&J Product Security’s overarching framework.
- Support the Product Security strategy and objectives within Heart Recovery.
- Define and implement secure boot, firmware integrity validation, and anti-tamper mechanisms to protect Heart Recovery Device firmware against unauthorized modification.
- Enforce cryptographic protocols for data-at-rest and data-in-transit, ensuring compliance with FDA cybersecurity requirements, NIST 800-175, FIPS 140-3, and IEC 62443.
- Define and implement key management infrastructure (PKI, HSMs, TPMs, and secure enclave integration) for device identity, authentication, and software signing.
- Develop real-time vulnerability assessment techniques for detecting security flaws in wireless communications (Bluetooth LE, NFC, Wi-Fi, 5G, proprietary RF) used in Heart Recovery’s medical devices.
- Implement Zero Trust security for device-to-cloud connectivity, integrating mTLS and continuous authentication models into clinical applications.
- Oversee secure OTA (over-the-air) update mechanisms, ensuring firmware rollbacks, code signing, and supply chain integrity validation.
- Lead Secure Development Lifecycle practices, integrating threat modeling, static/dynamic analysis, fuzz testing, and formal verification into the development process.
- Work with R&D Engineering to define hardware security architecture, including trust zones, hardware root of trust (HRoT), and secure microcontroller protections.
- Implement memory safety strategies to mitigate buffer overflows, side-channel attacks, and execution vulnerabilities in real-time operating systems (RTOS) and bare-metal firmware.
- Respond to customer cybersecurity questionnaires and contractual language for post-market medical devices under your responsibility as necessary.
Requirements
- 5+ years industry experience in Information Security
- 3+ years experience with embedded system, IOT, or medical device cybersecurity
- Bachelor’s degree or equivalent
- Experience generating Threat models without the use of threat modeling tools
- Experience performing risk assessments utilizing CVSS 3.1 or higher, with STRIDE per element
- Ability to write technical security requirements for embedded systems and web platforms based on the latest regulations
- Understanding and execution of third-party penetration testing, vulnerability scanning, CVSS and/or other general security testing principles
- Experience supporting regulatory security submissions, ensuring compliance with FDA Cybersecurity Guidance (2025), EU MDR, NIST 800-53, IMDRF, and AAMI TIR57.
- Knowledge of real-time operating systems hardening techniques
- Knowledge of cloud security principles
- Ability to generate SBOMs from Software source code and Binaries, Firmware, and Operating Systems
- Ability to generate pre-market risk assessments against the threat model leveraging STRIDE and post-market risk assessments via SCA SBOM scans.
- Ability to generate the security architecture views for medical devices that could include: Global System View, Multi-Patient Harm View, Updateability/Patchability view and, detailing system boundaries, data flows, and external interactions to show risk mitigation, ensuring transparency, and supporting post-market management
- Ability to translate technical security requirements into solutions
- Ability to provide secure coding recommendations and execute reviews
- Data privacy experience, including HIPAA and GDPR
- Understanding of industry standards and certifications such as HITRUST & ISO 27001
- Ability to work autonomously and proactively seek out product security opportunities within heart recovery
- Ability to lead large projects and proven ability to track to project plan timelines from a security perspective
- Ability to create and deliver cybersecurity awareness campaigns and other communications
- Creative problem-solving skills
- Customer focus (internal & external)
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
- Caregiver Leave – 10 days
- Volunteer Leave – 4 days
- Military Spouse Time-Off – 80 hours
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