Principal Med Device Security Engineer Job Augusta area,Maine USA,IT/Tech

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 Med Tech, 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

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
57.
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…