Principal Med Device Security Engineer

Johnson & Johnson Innovative Medicine•Washington, NV

8d•$102,000 - $177,100•Hybrid

About The Position

Johnson & Johnson’s MedTech cybersecurity team is recruiting for an experienced Principal Product Security Engineer to be located in Danvers, MA. Remote work options may be considered on a case-by-case basis and if approved by the Company. This role will require up to 10%-20% travel. Are you passionate about security and interested in joining a community of collaborative colleagues working in a Patient First! culture? If that’s you, we have an immediate opportunity for a Principal Product Security Engineer to join the Product Cybersecurity team to help ensure security is implemented by design for this top-performing medical device company. This is an exciting opportunity to impact development initiatives that will shape future product development and industry standards. You will own the Product Security process for the products that you will support throughout the product development lifecycle which includes both pre-market and post-market processes engineering teams. If you are eager to leverage your security risk and compliance skills to make a difference and directly impact patient lives, this could be perfect for you. Purpose: 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. 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. 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.

Requirements

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
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

Nice To Haves

Experience leading or participating in formal security audits
Experience with Operating Systems such as QNX QOS, Yocto, Linux Ubuntu. Alpine
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
MS and/or advanced degree

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.
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, assist with patching and remediation plans for Heart Recovery marketed devices.
Review security language within contractual agreements as needed.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year