Bill rate is *** Temp to Perm possibility but that depends on experience !
We are seeking a Product Security Engineer to support Client s MMS Dispensing business unit. The Dispensing portfolio includes FDA Class I and Class II medical devices and their associated cloud-connected platforms. The product security engineer owns, leads, and executes the activities and documentation outlined in Client s security lifecycle. These activities and documents include Security Requirements, Threat Modeling, Risk Assessments and Analysis, Vulnerability & Risk Management Plans, Security Testing, and White Papers.
This role focuses on risk-based security that ensures patient safety, data protection, and regulatory readiness.
Role Focus
- Execution of Product Security Engineering Lifecycle activities
- Generation and Maintenance of Product Security Documentation
- Apply risk-proportionate security controls
- Emphasize secure-by-design and secure-by-default
- Enable efficient FDA submissions (510(k), De Novo)
- Balance usability, workflow, and security
Key Responsibilities
- Security Architecture & Design
- Define end-to-end security architecture across devices, apps, and cloud
- Establish baseline security patterns (auth, encryption, secure updates)
- Conduct Threat Modeling, Risk Assessments, Requirements/Controls Mapping, Security White Papers
- Lead and Drive Security Design Reviews & Roadmap Remediations/Mitigations
Secure SDLC
- Implement lean Secure SDLC aligned to NIST, OWASP, and BSIMM
- Integrate SAST, SCA, secrets scanning, container/IaC scanning
- Define minimum viable security gates
Regulatory & Compliance
- Support FDA cybersecurity documentation (threat models, SBOMs, risk assessments)
- Align with IEC 62304, ISO 14971
- Ensure audit-ready documentation
Cloud Security
- Architect secure integrations with Client s Cloud Platforms
- Secure device-to-cloud data flows
SBOM & Vulnerability Management
- Establish SBOM processes (SPDX, CycloneDX)
- Implement continuous vulnerability monitoring
- Define risk-based remediation SLAs
Cross-Functional Leadership
- Collaborate with engineering, quality, regulatory, and product teams
- Translate security into patient safety and business risk
- Mentor teams
Required Qualifications
- 5 + years cybersecurity experience
- Experience with FDA Class I/II devices
- Regulatory/Quality Control product development
- Demonstrated working experience in the domains of embedded, cloud, and application security
- FDA submissions
Preferred Qualifications
- Software Development, System Engineering background
- AI (Agentic, Generative, ML) skills and agent development
- Experience with IoMT ecosystems
- Knowledge of FDA Cybersecurity Pre & Post Market Guidance, UL 2900, AAMI TIR57/TIR97
- DevSecOps experience
- Certifications (CISSP, CCSP, CSSLP)
- Experience working in cross-functional product development environments
- Experience presenting technical security concepts to leadership and business stakeholders
- Proven track record of driving security initiatives from concept through implementation
Key Competencies
- Ability to right-size security controls
- Strong risk-based decision-making
- Communication across technical and non-technical teams
-Strong stakeholder management skills
-Ability to build credibility and trust across cross-functional teams
-Excellent verbal, written, and presentation communication skills
-Ability to navigate ambiguity and drive consensus
-Ability to balance competing priorities in a fast-paced environment
Success Metrics
- Comprehensive Threat Modeling and effective Security Risk Management
- SBOM completeness
- Reduction in critical vulnerabilities
- FDA submission success
- Time-to-remediate vulnerabilities
- Timely completion of security lifecycle deliverables
- On-time support of product release and submission milestones
Applications must be located in the Orange County / San Diego metro area.
Bill rate is *** Temp to Perm possibility but that depends on experience !
We are seeking a Product Security Engineer to support Client s MMS Dispensing business unit. The Dispensing portfolio includes FDA Class I and Class II medical devices and their associated cloud-connected platforms. The product security engineer owns, leads, and executes the activities and documentation outlined in Client s security lifecycle. These activities and documents include Security Requirements, Threat Modeling, Risk Assessments and Analysis, Vulnerability & Risk Management Plans, Security Testing, and White Papers.
This role focuses on risk-based security that ensures patient safety, data protection, and regulatory readiness.
Role Focus
- Execution of Product Security Engineering Lifecycle activities
- Generation and Maintenance of Product Security Documentation
- Apply risk-proportionate security controls
- Emphasize secure-by-design and secure-by-default
- Enable efficient FDA submissions (510(k), De Novo)
- Balance usability, workflow, and security
Key Responsibilities
- Security Architecture & Design
- Define end-to-end security architecture across devices, apps, and cloud
- Establish baseline security patterns (auth, encryption, secure updates)
- Conduct Threat Modeling, Risk Assessments, Requirements/Controls Mapping, Security White Papers
- Lead and Drive Security Design Reviews & Roadmap Remediations/Mitigations
Secure SDLC
- Implement lean Secure SDLC aligned to NIST, OWASP, and BSIMM
- Integrate SAST, SCA, secrets scanning, container/IaC scanning
- Define minimum viable security gates
Regulatory & Compliance
- Support FDA cybersecurity documentation (threat models, SBOMs, risk assessments)
- Align with IEC 62304, ISO 14971
- Ensure audit-ready documentation
Cloud Security
- Architect secure integrations with Client s Cloud Platforms
- Secure device-to-cloud data flows
SBOM & Vulnerability Management
- Establish SBOM processes (SPDX, CycloneDX)
- Implement continuous vulnerability monitoring
- Define risk-based remediation SLAs
Cross-Functional Leadership
- Collaborate with engineering, quality, regulatory, and product teams
- Translate security into patient safety and business risk
- Mentor teams
Required Qualifications
- 5 + years cybersecurity experience
- Experience with FDA Class I/II devices
- Regulatory/Quality Control product development
- Demonstrated working experience in the domains of embedded, cloud, and application security
- FDA submissions
Preferred Qualifications
- Software Development, System Engineering background
- AI (Agentic, Generative, ML) skills and agent development
- Experience with IoMT ecosystems
- Knowledge of FDA Cybersecurity Pre & Post Market Guidance, UL 2900, AAMI TIR57/TIR97
- DevSecOps experience
- Certifications (CISSP, CCSP, CSSLP)
- Experience working in cross-functional product development environments
- Experience presenting technical security concepts to leadership and business stakeholders
- Proven track record of driving security initiatives from concept through implementation
Key Competencies
- Ability to right-size security controls
- Strong risk-based decision-making
- Communication across technical and non-technical teams
-Strong stakeholder management skills
-Ability to build credibility and trust across cross-functional teams
-Excellent verbal, written, and presentation communication skills
-Ability to navigate ambiguity and drive consensus
-Ability to balance competing priorities in a fast-paced environment
Success Metrics
- Comprehensive Threat Modeling and effective Security Risk Management
- SBOM completeness
- Reduction in critical vulnerabilities
- FDA submission success
- Time-to-remediate vulnerabilities
- Timely completion of security lifecycle deliverables
- On-time support of product release and submission milestones
Applications must be located in the Orange County / San Diego metro area.
| Location | San Diego, CA |
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