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 Senior Software Quality Engineer is responsible for performing design assurance activities for new introductions and sustaining of medical device software, with the purpose of supporting the Software R&D;, Test and Manufacturing departments. The incumbent for this position will support the Software Development Lifecycle of one or more projects from concept generation through production. This person will work closely with software design, software testing, project management, product management, regulatory, human factors, and manufacturing teams to understand and influence the architecture, requirements, detail design, testing, safety and cybersecurity risk evaluation and deployment of the software designs to the market.
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 soft