Senior Product Security Architect- Medical Devices FDA

Immediate need for a talented Senior Product Security Architect- Medical Devices FDA. This is a 06+months contract opportunity with long-term potential and is located in San Deigo, CA(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), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: 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 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 Clityoud Secur 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 Key Requirements and Technology Experience: Key Skills; Strong System Architecture & Integration Experience in FDA Hands-on Security Solutioning R&D / Product Engineering Background 10+ Years Relevant Technical Security 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 Equipment Manufacturing Industry, 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. Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here .