Senior Software Quality Engineer
Core
Performing design assurance activities for new introductions and sustaining medical device software to support Software R&D, Test, and Manufacturing departments.
Role type
Senior Software Quality Engineer (Medical Devices)
Builds
Medical device software for dialysis systems (Tablo® Hemodialysis System)
Domain
Medical devices / Dialysis / Embedded Software
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design assurance, Quality System Regulations (ISO13485, ISO14971, ISO62304, SW96), Risk management, Design Verification and Validation, CAPA investigation, Defect tracking, Root cause analysis, Automated testing alignment
Preferred skills
Certified Quality Engineer, Lead Auditor, Lean Certification, Statistical analysis software
Technologies
ISO13485, ISO14971, ISO62304, ANSI/AAMI SW96, FDA regulations
Responsibilities
Support SQA strategy and operational execution plans, Engage with development teams to align best practices for automated unit and integration testing, Lead or contribute to safety and cybersecurity risk management, Support Design Verification and Validation planning and execution, Collect, analyze, trend, and communicate quality data, Support internal and external audits
Seniority
Senior, hands-on IC with mentorship