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: 26-11974Pay 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 FocusApply risk-proportionate security controlsEmphasize secure-by-design and secure-by-defaultEnable efficient FDA submissions (510(k), De Novo)Balance usability, workflow, and securitySecurity Architecture & DesignDefine end-to-end security architecture across devices, apps, and cloudEstablish baseline security patterns (auth, encryption, secure updates)Conduct Threat Modeling, Risk Assessments, Requirements/Controls Mapping, Security White PapersLead and Drive Security Design Reviews & Roadmap Remediations/MitigationsSecure SDLCImplement lean Secure SDLC aligned to NIST, OWASP, and BSIMMIntegrate SAST, SCA, secrets scanning, container/IaC scanningDefine minimum viable security gatesRegulatory & ComplianceSupport FDA cybersecurity documentation (threat models, SBOMs, risk assessments)Align with IEC 62304, ISO 14971Ensure audit-ready documentationClityoud SecurArchitect secure integrations with BD’s Cloud PlatformsSecure device-to-cloud data flowsSBOM & Vulnerability ManagementEstablish SBOM processes (SPDX, CycloneDX)Implement continuous vulnerability monitoringDefine risk-based remediation SLAsCross-Functional Leadership Collaborate with engineering, quality, regulatory, and product teamsTranslate security into patient safety and business riskMentor teamsKey Requirements and Technology Experience: Key Skills; Strong System Architecture & Integration Experience in FDAHands-on Security SolutioningR&D / Product Engineering Background10+ Years Relevant Technical Security Experience10+ years cybersecurity experienceExperience with FDA Class I/II devicesKnowledge of embedded, cloud, and application securityFamiliarity with FDA submissionsExperience with IoMT ecosystemsKnowledge of FDA Cybersecurity Pre & Post Market Guidance, UL 2900, AAMI TIR57/TIR97DevSecOps experienceCertifications (CISSP, CCSP, CSSLP)Ability to right-size security controlsStrong risk-based decision-makingCommunication across technical and non-technical teamsSBOM completenessReduction in critical vulnerabilitiesFDA submission successTime-to-remediate vulnerabilitiesOur 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.