Cybersecurity and Data Protection Software Quality Engineer

Role: Software Quality Engineer specializing in cybersecurity for FMI medical devices, ensuring compliance with cybersecurity standards and risk management across the product lifecycle. Responsibilities: guide QMS procedures to embed cybersecurity requirements, review cybersecurity documentation for regulatory submissions (De Novo, PMA, 510(k)), manage Software Bill of Materials (SBOM), conduct risk assessments, oversee post-market vulnerability monitoring and patching, and support audit preparations. Collaborate cross-functionally with Product Owners, Software Engineering, IT, Data Privacy, and Regulatory teams to implement 'security by design' and maintain documentation. Qualifications: Bachelor's in information systems, IT, or related field; 2+ years in software quality assurance or healthcare cybersecurity; strong knowledge of IT infrastructure; hands-on experience with regulatory cybersecurity submissions; familiarity with ISO 13485, IEC 62304, ISO 14971. Preferred: detail-oriented, critical thinker, effective communicator, familiar with HIPAA, patient safety, and data privacy. HighValue: healthcare/medical device cybersecurity, regulatory compliance, risk management, SDLC, post-market surveillance. Location: Boston, MA; salary $93.5K–$116.5K, with potential bonus and benefits.