Senior Software Quality Engineer, Product/Software Cybersecurity (Medical Device Software)
Core
Ensuring cybersecurity of product software including SaMD, SiMD, and Digital Health Technologies throughout the product lifecycle.
Role type
Senior Software Quality Engineer (Cybersecurity)
Builds
Cybersecurity processes and regulatory compliance for medical device software
Domain
Medical Device / Digital Health / Cybersecurity
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cybersecurity risk analysis, Software development in regulated environments, Quality Management System (QMS) process ownership, Regulatory standards alignment, SDLC integration, Vulnerability management, Risk management (ISO 14971), NIST guidelines, IEC 62304, Waterfall and Agile concepts
Preferred skills
Medical device industry experience, Cybersecurity risk assessments, Post-market cybersecurity processes, Software guidelines (IEC 62304), Cybersecurity guidelines (NIST), SDLC design controls
Technologies
QMS systems, ALM systems, PLM systems
Responsibilities
Own establishment and improvement of cybersecurity processes in QMS, Review and approve cybersecurity deliverables across lifecycle, Execute cybersecurity risk analysis, Provide assurance on cybersecurity requirement adherence, Partner with cross-functional teams on risk monitoring, Support regulatory submissions, Author and approve lifecycle documents
Seniority
Senior, hands-on IC