> Markdown version of [/jobs/ext/1248955-sr-cybersecurity-specialist](https://www.wearedevelopers.com/jobs/ext/1248955-sr-cybersecurity-specialist). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Sr. Cybersecurity Specialist - **Company:** Intone Networks - **Location:** United States (Remote available) - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Software System Penetration Testing, Bluetooth, Cyber Security, Systems Development Life Cycle, Software Engineering, Cloud Integration, Vulnerability Analysis - **Published:** July 12, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=8ca1f418883bdb54 ## About the Role Key Qualifications Medical Device Experience (5+ Years): A minimum 5 years of direct, hands-on experience in medical device cybersecurity, preferably a Class III devices. Have demonstrated experience in creating documentation for at last one FDA 510K, PMA submission, or EU MDR technical documentation submission. Hands-on experience with standards like ISO 14971, IEC 62304 and ISO 13485 and experience in aligning these with regulatory requirements. Proven track record of working on devices with Bluetooth communication, mobile apps, and cloud integration. Regulatory Documentation Expertise: In-depth knowledge of FDA submission requirements, including: Cybersecurity documentation for 510(k) and PMA submissions. Creation of threat models, risk management files, and security testing reports tailored to FDA guidance. Familiarity with CE marking requirements for the EU, including: Cybersecurity sections for Technical Documentation under MDR. Ensuring compliance with ISO 14971, IEC 62304, and IEC/TR 60601-4-5. Demonstrated ability to produce submission-ready documentation in formats acceptable to both the FDA and Notified Bodies. SDLC Integration: Expertise in integrating threat and vulnerability management across the Software Development Lifecycle (SDLC). Ability to trace threats, risks, and mitigations through design, development, and testing stages, ensuring that all necessary artifacts are prepared and submission-ready for the specific Notified Body. Cybersecurity Risk Management: Experience in conducting and documenting: Threat modeling (e.g., STRIDE). Risk assessments and alignments with AAMI TIR57 and ISO 14971. Security testing results, including penetration testing and vulnerability assessments, documented in submission-ready formats. Standards and Compliance: Familiarity with relevant standards for medical device cybersecurity: FDA Premarket Guidance for cybersecurity risk management. ISO 13485 for quality system integration. IEC 62304 for secure software lifecycle processes. Communication and Collaboration: Strong ability to work cross-functionally with engineering, regulatory, and quality teams to ensure submission documentation meets all regulatory requirements. Experience presenting and defending cybersecurity strategies and documentation during audits or regulatory reviews. ## Related Videos - [Security Pitfalls for Software Engineers](https://www.wearedevelopers.com/videos/726-security-pitfalls-for-software-engineers) - [Next Level Enterprise Architecture: Modular, Flexible, Scalable, Multichannel and AI-Ready?](https://www.wearedevelopers.com/videos/1017-next-level-enterprise-architecture-modular-flexible-scalable-multichannel-and-ai-ready) - [Thinking Differently - How to Make Money from Cyber Attacks & Cheats](https://www.wearedevelopers.com/videos/745-thinking-differently-how-to-make-money-from-cyber-attacks-cheats) - [Building a Cross-Platform BLE Client with Kotlin Multiplatform and Kable](https://www.wearedevelopers.com/videos/100250-building-a-cross-platform-ble-client-with-kotlin-multiplatform-and-kable) - [Cyber Security: Small, and Large!](https://www.wearedevelopers.com/videos/259-cyber-security-small-and-large) - [What makes Cybersecurity different for critical infrastructure?](https://www.wearedevelopers.com/videos/571-what-makes-cybersecurity-different-for-critical-infrastructure) ## Related Articles - [Events like RSAC Get You CISOs. Developers Decide What Actually Gets Deployed.](https://www.wearedevelopers.com/magazine/693-events-like-rsac-get-you-cisos-developers-decide-what-actually-gets-deployed) - [Dev Digest 134 - Where pixels sing?](https://www.wearedevelopers.com/magazine/477-dev-digest-134-where-pixels-sing) - [Walking Into The Era of Supply Chain Risks](https://www.wearedevelopers.com/magazine/106-walking-into-the-era-of-supply-chain-risks) - [9 Ways to Make Money Hacking](https://www.wearedevelopers.com/magazine/333-9-ways-to-make-money-hacking) - [The Overflow: Security and Privacy](https://www.wearedevelopers.com/magazine/715-the-overflow-security-and-privacy) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs)