Staff Software Quality Engineer

Outset Medical seeks a Staff Software Quality Engineer to lead software design assurance and quality strategy for FDA-cleared medical device software and digital health solutions. This technical leadership role partners across engineering, regulatory, manufacturing, and quality functions to ensure compliance with regulatory standards and internal quality procedures throughout the software lifecycle.

Responsibilities

• Partner with regulatory, engineering, and manufacturing teams to establish and maintain design controls with appropriate objective evidence
• Develop and execute software quality assurance strategy and operational execution plans for assigned projects
• Provide technical guidance on testing strategy, verification/validation planning, and protocol development to cross-functional teams
• Lead safety and cybersecurity risk management activities and assessments
• Monitor customer feedback and defect reports through tracking systems to support issue resolution and continuous improvement

Requirements

• Working knowledge of FDA Quality System requirements, ISO 13485, ISO 14971, IEC 62304, and applicable cybersecurity standards
• Experience with software testing strategy, verification and validation planning, and test protocol development
• Proficiency in design controls and objective evidence documentation for regulated medical device software
• Background in quality assurance, design assurance, or software quality engineering for medical devices
• Demonstrated technical leadership and cross-functional collaboration skills
• Knowledge of automated unit and integration testing practices and methods