Immediate need for a talented Senior Product Security Architect Medical Device. This is a 08+months contract opportunity with long-term potential and is located in San Diego/Orange County, CA area(Remote). Please review the job description below and contact me ASAP if you are interested.
Job ID: 26-11974
Pay Range: $85/hr - $90/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision).
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 BD 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
- Role Focus
- 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 Requirements and Technology Experience:
- 10+ years cybersecurity experience
- Experience with FDA Class I/II devices
- Knowledge of embedded, cloud, and application security
- Familiarity with FDA submissions
- Experience with IoMT ecosystems
- Knowledge of FDA Cybersecurity Pre & Post Market Guidance, UL 2900, AAMI TIR57/TIR97
- DevSecOps experience
- Certifications (CISSP, CCSP, CSSLP)
- Ability to right-size security controls
- Strong risk-based decision-making
- Communication across technical and non-technical teams
- SBOM completeness
- Reduction in critical vulnerabilities
- FDA submission success
- Time-to-remediate vulnerabilities
Our client is a leading Medical DeviceIndustry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
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