Principal Med Device Security Engineer

Principal Product Security Engineer

Johnson & Johnson’s Med Tech cybersecurity team is recruiting for an experienced Principal Product Security Engineer. The role can be remote-based or located onsite in Danvers, MA or Raritan, NJ and requires up to 10% travel.

• Own the Product Security process for products throughout the product development lifecycle, supporting both pre‑market and post‑market processes.
• Design security architecture, cryptographic controls, embedded system protections/controls, and threat mitigation techniques to ensure regulatory‑compliant security across the product lifecycle.
• Support heart recovery throughout a new product’s development phases, review product security requirements, recommend security design solutions, complete quality documentation, threat modelling, and coordinate third‑party penetration testing.
• Conduct software architecture reviews and design recommendations, code analysis, and other security testing work as needed.
• Provide post‑market responsibilities for Heart Recovery marketed devices, including monitoring new vulnerabilities, assisting with patching and remediation plans, responding to customer security questionnaires, and reviewing security language within contractual agreements.
• Drive alignment to J&J Product Security’s overarching framework and 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 responsibility as necessary.

• 8+ years industry experience in Information Security.
• 5+ 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 TIR
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• 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…