Senior Software Quality Engineer

Outset Medical · San Jose, CA

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Role summary

Senior Software Quality Engineer at Outset Medical supports design assurance for medical device software across the development lifecycle. This role collaborates with R&D, regulatory, manufacturing, and testing teams to ensure compliance with quality standards and deploy safe, effective dialysis technology solutions.

What they're looking for

Experience with IEC 62304, ISO 13485, ISO 14971, and software development standards
Knowledge of design control methodologies and Quality Management Systems
Expertise in safety and cybersecurity risk management processes
Background in medical device or regulated software development
Cross-functional collaboration and team mentoring capabilities
Proficiency with defect tracking and problem-solving methodologies

What you'll be doing

Perform design assurance activities for software throughout development lifecycle from concept to production
Support Software Quality Assurance strategy execution and operational planning
Lead safety and cybersecurity risk management including risk assessment and documentation
Collaborate with development teams on automated testing best practices and techniques
Monitor customer feedback and manage defect tracking and root cause analysis

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