Johnson & Johnson · 4 hours ago
Sr. Manager Medical Devices Product Security
Danvers, Massachusetts, United States of America
Full-time
Hybrid
Senior Level, Lead/Staff
$122K/yr - $213K/yr
10+ years expJohnson & Johnson is a leading healthcare company focused on innovative medicine and MedTech solutions. They are seeking a Sr. Manager Medical Devices Product Security to implement their enterprise Product Security strategy and framework for medical devices, ensuring security is integrated throughout the product lifecycle and addressing both pre-market and post-market processes.
Hospital & Health Care
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
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
Qualification
Required
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
Preferred
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
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Company’s 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 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
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
Company data provided by crunchbase