Principal Medical Device Security Engineer

Johnson & Johnson

Principal Product Security Engineer leading product security efforts for medical devices at Johnson & Johnson. Implementing security strategies to protect patient health through innovative technology.

Posted 7/16/2026full-timeDanvers • Maine, Massachusetts, Nevada, Pennsylvania, South Carolina • 🇺🇸 United StatesLead💰 $102,000 - $177,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in implementing security strategies for medical devices, focusing on embedded systems and IoT, while ensuring compliance with regulatory standards such as FDA Cybersecurity Guidance and NIST. Proficient in threat modeling, vulnerability assessment, and secure coding practices to enhance product security throughout the development lifecycle.

Highest-signal resume keywords

Information Security ExpertiseEmbedded Systems CybersecurityThreat Modeling and Risk AssessmentRegulatory Compliance (FDA, NIST)Secure Development Lifecycle Practices

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Threat ModelingRisk Assessment (CVSS 3.1)Vulnerability ScanningSecure Coding RecommendationsFirmware Integrity ValidationCryptographic ProtocolsReal-Time Operating Systems HardeningData Privacy (HIPAA, GDPR)Zero Trust Security ImplementationSecure Boot Mechanisms

Soft Skills

Creative Problem-SolvingCustomer FocusExcellent CommunicationCollaboration SkillsLeadership Skills

Tools & Technologies

Penetration Testing ToolsSoftware Composition Analysis (SCA)Secure Enclave IntegrationPublic Key Infrastructure (PKI)Hardware Security Modules (HSMs)Trusted Platform Modules (TPMs)Over-The-Air (OTA) Update MechanismsContinuous Authentication ModelsBluetooth LE SecurityWi-Fi Security

Certifications & Qualifications

HITRUSTISO 27001

Industry Keywords

Medical Device CybersecurityIoT SecurityNIST 800-53AAMI TIR57EU MDRFDA Cybersecurity GuidanceCybersecurity Awareness CampaignsEmbedded SystemsHeart Recovery TechnologiesConnected Medical Devices

Tech Stack

Tools & technologies

CloudCyber SecurityIoTRTOS

About the role

Key responsibilities & impact

Responsible for implementation of J&J’s enterprise Product Security strategy and framework throughout the Heart Recovery portfolio of medical devices and supporting platforms.
Provide technical expertise and strategic leadership in securing Impella heart pump technologies, next-generation cardiac support systems, and connected medical devices.
Deliver security architecture, cryptographic controls, embedded system protections/controls, and threat mitigation techniques to ensure robust, regulatory-compliant security across the product lifecycle.
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.
Monitor 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.
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

What you’ll need

8+ years industry experience in Information Security
5+ years experience with embedded systems, 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)
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

Benefits

Comp & perks

Pension plan (401(k))
120 hours vacation per calendar year
40 hours sick time per calendar year
13 days holiday pay including floating holidays per calendar year
40 hours work, personal, and family time per calendar year
480 hours parental leave within one year of the birth/adoption/foster care of a child
240 hours bereavement leave for immediate family members, and 40 hours for extended family members per calendar year
80 hours caregiver leave in a 52-week rolling period
32 hours volunteer leave per calendar year
80 hours military spouse time-off per calendar year