Johnson & Johnson is a leader in healthcare innovation, dedicated to improving health outcomes through advanced technology. They are seeking a Principal Product Security Engineer to join their MedTech cybersecurity team, responsible for implementing security strategies for medical devices and ensuring compliance with regulatory standards. The role involves overseeing product security throughout the development lifecycle and addressing post-market security challenges.
Responsibilities:
- 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:
- Bachelor's degree or equivalent
- 8+ years industry experience in Information Security
- 5+ years experience with embedded system, IOT, or medical device cybersecurity
- 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)
- Excellent communication and collaboration skills, able to network, interface and influence at all levels of the organization, cross sector, cross-functionally and globally
- Strong leadership skills
- MS and/or advanced degree
- Experience leading or participating in formal security audits
- Experience with Operating Systems such as QNX QOS, Yocto, Linux Ubuntu
- Familiarity with FDA and/or other global regulatory cybersecurity guidance requirements and submission process
- Experience with web applications and server hardening (i.e. AWS, Azure) including knowledge of OWASP Top 10 and blue teaming techniques
- Experience in cybersecurity pre-sales
- Software development experience
- CISSP, CISM, or other security certification