Senior Software Quality Engineer
Core
Design assurance and quality engineering for medical device software, supporting the Software R&D, Test, and Manufacturing departments from concept to production.
Role type
Senior Software Quality Engineer (Medical Devices)
Builds
FDA-cleared Tablo® Hemodialysis System and related medical device software
Domain
Medical Devices / Dialysis / Embedded Software
Required skills
Design assurance, ISO 13485, ISO 14971, ISO 62304, ANSI/AAMI SW96, FDA regulations, risk management, CAPA, root cause analysis, automated testing, defect tracking, quality data analysis
Preferred skills
Certified Quality Engineer, Lead Auditor, Lean Certification, statistical analysis software
Technologies
ISO 13485, ISO 14971, ISO 62304, ANSI/AAMI SW96, FDA QSR
Responsibilities
Support SQA strategy and operational execution; Engage with development teams to align best practices for automated testing; Lead safety and cybersecurity risk management; Support Design Verification and Validation planning and execution; Collect, analyze, and trend quality data; Support internal and external audits
Seniority
Senior, hands-on IC with mentorship