Sr. Manager Medical Devices Product Security

Johnson & Johnson•Danvers, MA

7d•Hybrid

About The Position

Johnson & Johnson’s MedTech cybersecurity team is recruiting for an experienced Sr. Manager Medical Devices Product Security to be based in Danvers, MA or Raritan, NJ. This role can also be remote or hybrid work. This role will require up to 10% travel. As the world’s most comprehensive MedTech business, J&J MedTech Companies are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across heart recovery, surgery, orthopedics and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life. For more information, visit https://www.jnjmedtech.com/en-US At Johnson & Johnson, we all belong. 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 Sr. Manager Medical Devices Product Security 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. The Sr. Manager Medical Devices Product Security 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.

Requirements

10+ years industry experience in Information Security.
5+ years experience with embedded system, IOT, or medical device cybersecurity.
Bachelor’s degree or equivalent.
Expertise generating Threat models without the use of threat modeling tools.
Expertise performing risk assessments utilizing CVSS 3.1 or higher, with STRIDE per element.
Experience writing technical security requirements for embedded systems and web platforms based on the latest regulations.
Coordination and execution of third-party penetration testing, vulnerability scanning, CVSS and/or other general security testing principles.
Experience supporting regulatory security submissions and generating Cybersecurity QMS documentation, ensuring compliance with FDA Cybersecurity Guidance (2025), EU MDR, NIST 800-53, IMDRF, and AAMI TIR57.
Experience with real-time operating system hardening and pruning techniques and generating detailed SBOMs with software composition analysis
Experience with cloud security and controls and securely connecting embedded medical devices to the cloud.
Experience generating detailed SBOMs from Software source code and Binaries, Firmware, and Operating Systems.
Experience generating pre-market risk assessments against the threat model leveraging STRIDE and post-market risk assessments via SCA SBOM scans.
Experience generating 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.
Experience translating technical security requirements into solutions.
Ability to provide secure coding recommendations and experience executing code reviews.
Data privacy experience, including HIPAA and GDPR.
Understanding of industry standards and certifications such as HITRUST & ISO 27001, and IEC 81001-5-1.
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.
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

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.
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.
Define and 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 and ensure Secure Development Lifecycle practices are followed, integrating threat modeling, static/dynamic analysis, fuzz testing, and formal verification into the development process.
Define and Influence 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.

Benefits

medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Company’s consolidated retirement plan (pension) and 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 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
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours