The Principal Cloud 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 of the Cloud security controls and documentation to the J&J Product Security’s overarching framework.
Define and prioritize compliance with the FDA Pre-Market Guidance Appendix 1
Define the security requirements required for USA 510k, EU MDR, and Japan PDMA compliance
Support the Product Security strategy and objectives within Heart Recovery
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, cloud-based HSMs)) for device identity, authentication, and software signing.
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 software and firmware rollbacks, code signing, and supply chain integrity validation.
Partner with engineering teams (cloud, console) to drive successful adherence to the product security policies, processes, framework and program objectives.
Create, update, and improve product security processes for the cloud infrastructure and application.
Act as an SME on cyber security matters and provide guidance to engineering and cross-functional teams.
Advocate for proactive inclusion of cyber security controls and processes into all phases of the product life cycle, process improvements, strategic product road map planning.
Support compliance certification activities, such as SOC2 Type2, FedRAMP, ISO 27001, 81001-5-1, etc.
Identify, research, evaluate, and integrate new compliance requirements, industry standards, and best practices into the product security programs.
Maintain relationships with Heart Recovery’s Information Sharing and Analysis Organizations.
Guide teams to make decisions that balance business needs with medical device security objectives.
Perform other related duties and responsibilities, as assigned.

Requirements

Bachelor’s degree
5+ years industry experience in Information Security.
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
Experience architecture and securing MS Azure with configuring and hardening Azure security services
Experience working in a Cloud Scrum/Agile Azure DevOps environment.
Familiarity with some or all of these tools: Snyk, Veracode, Coverity, Wiz, JIRA, Confluence, Dependency-Track
Experience with Containerization technologies such as Docker and Kubernetes and implementing security controls.
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.
Working knowledge of regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework, ISO27001, SOC2 Type 2, HIPAA, GDPR, 81001-5-1).
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 security architecture views for software as medical device (SAMD) Web applications that would 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 with security risk management techniques and developing Quality Management System documentation from draft through cross-functional approval
Demonstrated organizational skills, attention to detail, the ability to handle multiple assignments simultaneously in a timely manner and be able to meet assigned deadlines.
Committed to working independently with a sense of urgency and embracing new challenges.
Strong communication and interpersonal skills.

Benefits

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Applicant Tracking System Keywords

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Hard Skills & Tools

cloud securitythreat modelingrisk assessmentscryptographic controlssecurity architectureembedded systems securityvulnerability scanningsecurity risk managementcompliance certificationdata-at-rest and data-in-transit security

Soft Skills

organizational skillsattention to detailability to handle multiple assignmentssense of urgencystrong communication skillsinterpersonal skillsindependent workstrategic leadershipproactive inclusionguidance to cross-functional teams

Certifications

SOC2 Type 2FedRAMPISO 2700181001-5-1FDA Cybersecurity GuidanceNIST 800-53EU MDRAAMI TIR57