Staff Software Quality Engineer

Company Overview Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost, because patients deserve “better” now, not some day.  At Outset we’re revolutionizing an industry and changing lives. We’re impacting what the future of dialysis looks like by creating a first-of-its-kind technology in order to reduce the cost and complexity of dialysis. FDA cleared for use across care settings, from the hospital to the clinic to the home, the Tablo® Hemodialysis System harnesses modern technology for a new holistic approach to dialysis care. We’re giving providers time back to focus on patient care. And we’re giving patients the power to take control of their life and get back to enjoying the things they love. Position Overview The Staff Software Quality Engineer serves as a technical quality leader responsible for software design assurance, software quality strategy, and lifecycle quality oversight for medical device software and connected/digital health solutions. This role partners closely with Software Engineering, Test, Systems Engineering, Manufacturing, Regulatory Affairs, Product Management, Human Factors, Cybersecurity, and Quality teams to ensure software products are developed, verified, validated, released, and maintained in accordance with applicable regulatory requirements, consensus standards, and internal quality system procedures. The incumbent supports one or more projects across the software development lifecycle, from concept development through commercialization and sustaining engineering. This person must be versatile to support other design assurance activities such as data analysis, problem solving/ failure analysis, full QMS compliance and alignment with the software development practices, Business Process Optimization initiatives and continuous improvement to the Quality Management System. The Staff Software Quality Engineer also provides technical leadership, mentors other team members, and may serve as the Quality representative for hardware, system, or manufacturing-related projects when needed. Duties And Responsibilities • Partner with Regulatory Affairs, Software R&D, Test, Systems Engineering, Manufacturing, and other cross-functional teams to ensure appropriate design controls are established, implemented, maintained, and objectively evidenced. • Provide design assurance guidance for software testing strategy, test method development, verification planning, validation planning, protocol/report expectations, and objective evidence requirements. • Develop and execute Software Quality Assurance (SQA) strategy and operational execution plans. • Apply working knowledge of applicable medical device software and quality system standards, including FDA Quality System requirements, ISO 13485, ISO 14971, IEC 62304, IEC 62366, AAMI SW96, and applicable cybersecurity guidance, as appropriate to assigned products and projects. • Engage with the development team to align best practices and techniques for automated unit and integration testing. • Continuously monitor customer feedback and report defects found through defect tracking system, provide necessary information to reproduce the defect to arrive at a solution. • Serve as primary quality representative on one or more teams and projects for software, hardware, and system changes. • Lead / Contribute to all elements of safety and cybersecurity risk management. Assesses risk by facilitating the develop