Sr. Manager Medical Devices Product Security

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

Job Function:

Technology Enterprise Strategy & Security

Job Sub Function:

Security & Controls

Job Category:

People Leader

All Job Posting Locations:

Danvers Massachusetts United States of America Raritan New Jersey United States of America

Job Description:

Johnson & Johnsons 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 worlds 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 were working to profoundly change the way care is delivered. We are in this for life. For more information visit 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 thats 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.

Purpose: The Sr. Manager Medical Devices Product Security will be responsible for implementation of J&Js 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 products 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 Securitys 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 Recoverys 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 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.

Qualifications Required:

• 10 years industry experience in Information Security.
• 5 years experience with embedded system IOT or medical device cybersecurity.
• Bachelors 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.
• 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 Skills:

• 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.

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Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Business Process Design Collaborating Crisis Management Critical Thinking Cyber Threat Intelligence Developing Others Inclusive Leadership Information Security Auditing Information Security Management System (ISMS) Information Technology (IT) Security Assessments Information Technology Strategies Leadership Managing Managers People Performance Management Presentation Design Process Optimization Security Architecture Design Security Policies

The anticipated base pay range for this position is :

The anticipated base pay range for this position is: $122000- $212750

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire Employees are eligible for the following time off benefits: 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 Additional information can be found through the link below. Experience:

Manager