Senior Software Quality Engineer

Responsibilities

• Perform design assurance activities for new and sustaining medical device software
• Support the Software Development Lifecycle from concept through production
• Collaborate with R&D, Test, Manufacturing, and Regulatory teams to ensure design control compliance
• Lead safety and cybersecurity risk management activities
• Support Design Verification and Validation planning, execution, and reporting
• Drive CAPA investigations and root cause analysis
• Monitor customer feedback and manage defect tracking
• Support internal and external audits

Requirements

• Bachelor’s degree in Computer Science, Engineering, or similar
• Minimum 5 years of experience in Quality Engineering
• Prior experience in the medical device field is required
• Experience with capital equipment medical devices with embedded software
• Thorough knowledge of FDA Quality System requirements, ISO 13485, and ISO 14971
• Knowledge of IEC 62304 and ANSI/AAMI SW96
• Fluency in written and spoken English

Preferred Qualifications

• Master’s degree in a relevant field
• Certified Quality Engineer (CQE) certification
• Lead Auditor certification
• Lean Certification
• Experience with statistical analysis software

About the Company

Outset Medical is a trailblazing medical device company revolutionizing the field of dialysis. Through the Tablo® Hemodialysis System, Outset is creating first-of-its-kind technology to reduce the cost and complexity of dialysis care for patients and providers worldwide.