eNGINE · 1 month ago
Product Security Engineer
United States
Full-time
Remote
Senior Level
$160K/yr - $185K/yr
5+ years expeNGINE builds Technical Teams and is hiring a Senior Product Security Engineer to secure real-world, life-saving medical devices. The role involves embedding security into the design and development of connected medical devices, ensuring compliance with global standards while advancing security practices.
AccountingHuman ResourcesBookkeeping and PayrollEmploymentStaffing Agency
No H1B
Responsibilities
Lead and execute product security engineering activities across the full development lifecycle for network-connected embedded medical devices
Perform hands-on security work including triage, scripting, testing, and validation of product security controls
Drive threat modeling initiatives and guide teams in identifying and mitigating risks in both new and existing products
Support Software Bill of Materials (SBOM) and VEX vulnerability management, including tooling and process improvements
Implement and support Coordinated Vulnerability Disclosure (CVD) processes
Partner with engineering teams to design and integrate security controls, including encryption, authentication, and access controls
Develop and maintain traceability artifacts and documentation required for regulatory submissions
Support FDA cybersecurity requirements and approval processes, including pre- and post-market guidance
Collaborate with cross-functional teams to produce risk assessments, security test reports, and mitigation strategies
Stay current on emerging threats, technologies, and regulatory requirements, and share insights across the organization
Contribute to and maintain secure development policies and standards
Qualification
Required
Hands-on product security engineering experience—ideally working with physical or embedded devices (medical device experience strongly preferred)
Proven experience navigating FDA regulatory frameworks and participating in FDA approval processes
Strong background in embedded systems and embedded Linux environments
Solid understanding of networking fundamentals, including TCP/IP, secure communications, and certificate-based systems
Experience using Python for scripting, automation, or lightweight tooling
Familiarity with application security and testing tools (SAST, DAST, IAST, OSS scanning, fuzzing, etc.)
Deep knowledge of industry security frameworks and standards, including: FDA Pre- and Post-Market Cybersecurity Guidance, IEC 62304, TIR57, NIST Cybersecurity Framework, Global regulations (EU MDR, NMPA, etc.)
Bachelor's degree in Computer Science, Electrical/Computer Engineering, or related discipline
5+ years of experience in cybersecurity, with a focus on medical devices or healthcare technology
5+ years of product security experience
Comfortable working EST hours
Comfortable with quarterly travel to Pittsburgh, PA (reimbursed)
Preferred
Ability to bridge engineering and regulatory worlds, effectively communicating with both developers and FDA auditors
Strong bias toward hands-on execution, not just policy or oversight
Experience building scalable security processes for high-impact, regulated products
Passion for improving security in life-critical systems
Benefits
Schedule flexibility
Paid training/certifications
Quarterly travel to Pittsburgh, PA (reimbursed)
Company
eNGINE
eNGINE provides contract staffing, contract to hire, direct hire, quality check, and payroll services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Kristen Weiss
Senior Project Manager, in Partnership with PANTHERx
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