Note: The job is a remote job and is open to candidates in USA. eNGINE is a Solutions and Placement firm that focuses on building technical teams through continuous learning and engagement. They are hiring an Embedded Quality Assurance Engineer to integrate security controls in product development, lead threat modeling sessions, and guide teams on regulatory requirements related to cybersecurity for embedded systems.
Responsibilities
- Partner with embedded software teams to integrate security controls throughout the product development lifecycle
- Lead threat modeling sessions for new and existing network-connected embedded systems
- Drive SBOM and VEX vulnerability management using enterprise and team-preferred tooling
- Advise teams on secure coding practices, encryption, authentication, and access controls
- Develop cybersecurity documentation supporting regulatory submissions — risk assessments, security testing results, and mitigation strategies
- Support Coordinated Vulnerability Disclosure (CVD) processes
- Guide teams on U.S. and international regulatory requirements including FDA Pre- and Post-Market Cybersecurity Guidance, EUMDR, NMPA, TIR57, IEC 62304, and the NIST Cybersecurity Framework
- Monitor the evolving threat landscape and keep internal teams current on emerging risks and technologies
- Maintain and review secure development policies
Skills
- 5+ years of cybersecurity experience focused on medical devices or healthcare technology
- Solid understanding of embedded systems, embedded Linux, and cloud architectures (AWS preferred)
- Working knowledge of networking fundamentals — TCP/IP, secure communications, certificates, and protocols
- Hands-on experience with Python for scripting, automation, or lightweight security tooling
- Familiarity with SAST, DAST, IAST, OSS scanning, fuzzing, and threat modeling tools
- Strong knowledge of FDA Pre- and Post-Market Cybersecurity Guidance and related medical device regulatory frameworks
- Ability to communicate technical security concepts clearly to audiences ranging from developers to FDA auditors
- Bachelor's degree in Computer Science, Electrical/Computer Engineering, or a related discipline
- Experience with e-STAR submissions and cybersecurity architecture documentation
- Familiarity with SBOM generation pipelines and executive order compliance
- Background working in ISO 13485 or 21 CFR 820 regulated environments
Benefits
- Schedule flexibility
- Paid training/certifications
- Challenging projects
- Telecommute / Remote work (workplaceTypes: Remote; jobLocationType: TELECOMMUTE)
Company Overview
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