Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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У роли понятная специализация в востребованной кибербезопасности медтеха, но широкий круг координационных задач и требований к регуляторной экспертизе может сделать работу насыщенной.
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Описание вакансии
Текст:
Hirify AI/Оригинал
TL;DR
Cybersecurity and Data Protection Software Quality Engineer (Medical Devices/Cybersecurity): Ensuring software-enabled medical devices and quality-system software meet cybersecurity, data protection, and regulatory requirements with an accent on secure product development, threat modeling, SBOM management, and premarket submissions. Focus on reviewing risk assessments and verification results, supporting vulnerability monitoring and patching, and maintaining compliance across the software development lifecycle.
Location: Hybrid role based in Boston, Massachusetts, US
Salary: $93,500–$116,500 per year, plus a potential discretionary annual bonus and benefits.
Company
hirify.global develops software-enabled medical devices and software supporting a regulated healthcare quality system.
What you will do
Guide Quality Management System procedures to integrate secure product development, threat modeling, and SBOM management into design controls.
Review and approve cybersecurity documentation for De Novo, PMA, and 510(k) premarket submissions, including security risk reports, threat models, and security architecture views.
Manage compliant machine-readable SBOMs, track vulnerabilities and CVEs, and support supplier risk management.
Support post-market vulnerability monitoring, timely patching of fielded devices, audits, and supplier onboarding.
Advise Product Owners, System Owners, Engineering, IT, Information Security, Data Privacy, and Regulatory Affairs on cybersecurity and data protection throughout the SDLC.
Requirements
Bachelor’s degree or equivalent in information systems, information technology, or a related field.
2+ years of software quality assurance or cybersecurity experience at a midsize or large company in healthcare or another regulated environment.
Deep knowledge of IT, including hardware, software, and networks.
Direct experience with regulatory or notified body cybersecurity submissions.
Experience with ISO 13485, IEC 62304, and ISO 14971.
Understanding of HIPAA, patient safety, and data privacy regulations and guidelines.
Strong critical thinking, problem-solving, logic, forensic, verbal, and written communication skills; ability to work independently and collaboratively.
Meticulous attention to detail, ability to multitask in a fast-paced environment, and ability to think like a hacker to stay ahead of threats.
Commitment to FMI’s values of Integrity, Courage, and Passion.
Culture & Benefits
Hybrid work arrangement in Boston, Massachusetts.
Full-time position with hirify.global benefits.
Potential discretionary annual bonus based on individual and company performance.
Cross-functional work across product, engineering, IT, privacy, regulatory, and supplier-management functions.
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