Software Design Quality Engineer - Ultrasound
Core
Ensures software design quality, safety, and regulatory compliance for ultrasound medical devices throughout the development lifecycle.
Role type
Senior Software Design Quality Engineer
Builds
High-quality, compliant ultrasound software products
Domain
Medical Devices / Ultrasound / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Software Requirement Specifications (SRS), Root Cause Analysis (RCA), Design Quality Management, CAPA Methodologies, Regulatory Requirements, Technical Documentation, Software Development Life Cycle (SDLC), Defect Management, Design Verification Planning, Design Validation Planning
Preferred skills
Cyber security, Artificial intelligence, Data Analysis & Interpretation, Design for Quality (DFQ), Privacy, Safety and Security Risk Assessment, Product Quality and Reliability
Technologies
IEC 62304, IEC 82304
Responsibilities
Develop and maintain comprehensive software quality documentation and Software Quality Plans; Execute assessment of software designs against quality and safety standards; Conduct root cause analysis for software quality issues; Guide validation of key software design inputs; Utilize post-market analytics to monitor software performance; Provide guidance and mentorship on quality engineering practices and regulatory compliance.
Seniority
Senior, hands-on IC