Software QA Engineer 2
Core
Ensure conformance to software development processes and safety/quality regulations (IEC 62304, ISO 13485, 21 CFR 820) for continuous glucose monitoring devices.
Role type
Software Design Assurance Engineer (Medical Device)
Builds
CGM software systems for diabetes management
Domain
Medical Device / Biosensing Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device compliance (FDA 21 CFR 820, IEC 62304, ISO 13485, ISO 14971), SDLC processes (Agile, Waterfall), Requirements Analysis, Design/Development, Product Integration, Test, Software Quality Engineering, Risk Management (FMEA, SHA), Technical Documentation (Design History File, SOPs), Change Control Assessment, Mobile Application Experience
Preferred skills
Cyber Security knowledge, ASQ CSQE certification, Jama/Jira/Kettryx/Test Rails experience
Technologies
IEC 62304, 21 CFR 820, ISO 13485, ISO 14971, Agile, Waterfall, Jama, Jira, Kettryx, Test Rails
Responsibilities
Provide guidance on software regulations to cross-functional teams; Lead application and improvement of software development policies and validation practices; Provide technical guidance on equipment, software, and process requirements; Support post-market activities including risk assessments and CAPA; Review and approve technical documentation including design history files and protocols; Assess impact of change controls to maintain compliance.
Seniority
Mid-level, hands-on IC