Principal Med Device Security Engineer

About the role

The Principal 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.

Responsibilities

• Support 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.
• 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.
• 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.
• Embedded Security & Secure Development Lifecycle: 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.

Qualifications

• 10+ years industry experience in Information Security
• 8+ 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
• 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
• Experience leading or participating in formal security audits
• Familiarity with FDA and/or other global regulatory cybersecurity guidance requirements and submission process
• Experience with Operating Systems such as QNX QOS, Yocto, Linux Ubuntu. Alpine
• Familiarity 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
• MS and/or advanced degree