Staff Software Quality Engineer
Core
Technical quality leader responsible for software design assurance, quality strategy, and lifecycle oversight for medical device software and digital health solutions.
Role type
Staff Software Quality Engineer (Design Assurance)
Builds
FDA-cleared Tablo® Hemodialysis System and connected/digital health solutions
Domain
Medical devices (dialysis) + Software Quality Engineering
Required skills
Design Assurance, Software Quality Strategy, Lifecycle Quality Oversight, Risk Management, Regulatory Compliance (FDA/ISO), Root Cause Analysis, CAPA Management, Defect Tracking, Cross-functional Leadership, Technical Mentoring
Preferred skills
Certified Software Quality Engineer, Certified Quality Engineer, Lead Auditor, Lean, Statistical Analysis
Technologies
FDA QSR, ISO 13485, ISO 14971, IEC 62304, IEC 62366, AAMI SW96
Responsibilities
Partner with cross-functional teams to establish and maintain design controls; Provide design assurance guidance for testing strategy and validation planning; Develop and execute SQA strategy and operational plans; Lead safety and cybersecurity risk management; Support Design Verification and Validation planning and execution; Identify quality improvement opportunities and drive procedure updates; Collect, analyze, and trend quality data; Provide technical leadership and mentoring to team members; Serve as subject matter expert in internal and external audits
Seniority
Staff, technical leadership & mentorship