Software QA Engineer 1
Core
Ensure conformance to software development processes and safety/quality regulations (IEC 62304, ISO 13485, 21 CFR 820) for medical device software.
Role type
Senior IC Software Quality Assurance Engineer (Medical Device)
Builds
Medical device software products ensuring regulatory compliance and quality standards
Domain
Medical Device / Biosensing Technology
Required skills
Medical device compliance (IEC 62304, ISO 13485, 21 CFR 820), Software Design Assurance, Risk Management (FMEA, SHA), SDLC processes (Agile, Waterfall), Requirements Analysis, Software Verification & Validation, Technical Documentation, Change Control Management
Preferred skills
Mobile application experience, Web APIs, Cyber Security, ASQ CSQE certification
Technologies
IEC 62304, ISO 13485, 21 CFR 820, Agile, Waterfall, FMEA, SHA
Responsibilities
Provide guidance on regulations to cross-functional teams; Lead application and improvement of software development policies; Provide technical guidance on equipment, software, and process requirements; Support post-market activities (anomalies, risk assessments, CAPA); Review and approve technical documentation (DHF, SOPs, protocols); Assess impact of change controls; Communicate project status to management.
Seniority
Mid-Senior, hands-on IC with limited supervision