Software Design Quality Engineer
Core
Ensures software design quality, safety, and regulatory compliance throughout the lifecycle by creating documentation, assessing designs, and managing risk.
Role type
Software Design Quality Engineer
Builds
High-quality software products compliant with global regulations
Domain
Medical device software / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Software Requirement Specifications (SRS) creation, Design assessment, Root cause analysis, Validation of design inputs, Quality plan development, Post-market analytics, Regulatory standards knowledge, Risk management, Metrics reporting, Mentoring
Preferred skills
IEC 62304/82304 standards, Cyber security, Artificial intelligence, Design Quality Management, Data Analysis, Design for Quality (DFQ), CAPA methodologies, Privacy/Safety/Security risk assessment, Technical documentation, Continuous improvement, SDLC, Defect management, Design verification/validation planning, Product test design
Technologies
IEC 62304, IEC 82304, SDLC frameworks
Responsibilities
Develop and maintain Software Requirement Specifications (SRS), Assess software designs against quality and safety standards, Conduct root cause analysis for quality issues, Validate key design inputs (usability, reliability, safety, etc.), Oversee execution of software quality plans, Utilize post-market analytics for performance monitoring, Develop comprehensive Software Quality Plans, Provide guidance and mentorship on quality engineering practices, Report key software quality metrics
Seniority
Mid-level, hands-on IC