• 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 development of risk management tools and contributes to the completion of the overall product risk management file.
• Support Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities. Develop and execute system related verification and validation plans and protocols, and test reports for medical and non-medical device software.
• Identify product quality and quality system improvement opportunities and drive procedure updates when required.
• Support departmental effort in CAPA investigation and completion.
• Collect, analyze, trend, and communicate quality data throughout the organization for proper escalation and applicable resolution.
• Ensure compliance with applicable U.S. Food and Drug Administration regulations, other applicable regulatory requirements, company policies, procedures, processes, and assigned tasks.
• Develop and maintain strong relationships with internal and external stakeholders
• Provide technical leadership and mentoring to Quality Engineering team members and cross-functional partners.
• Serve as subject matter expert in internal and external audits
• Support additional activities, as assigned

• Bachelor’s degree in computer or engineering science, Electrical or Software Engineering (or similar)is required. Master’s degree preferred. Previous experience in the role can be considered.
• Minimum of 7 years of hands-on experience in Design Assurance / Quality Engineering discipline. Previous experience in the role can be considered.
• Prior experience in the medical device field is required; preferably experience with Capital Equipment medical devices with embedded software and/or digital health initiatives is required.
• Ability to work effectively in a fast paced and dynamic environment.
• Strong leadership, collaboration, and influencing skills, with the ability to guide teams through risk-based decision-making in a regulated environment.
• Strong written and verbal communication skills.
• Thorough knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 14971 (Risk Management) requirements, ANSI/ AAMI SW96, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
• Strong written and verbal communication skills.

• Certified Software Quality Engineer, Certified Quality Engineer, or equivalent certification preferred.
• Lead Auditor Certification a plus.
• Lean certification a plus.
• Experience with statistical analysis methods or statistical analysis software preferred.
• Self-starter with demonstrated ability to lead initiatives, influence teams, and drive results with limited supervision.
• Demonstrated ability to deliver best-practice outcomes, added value, and continuous improvement across the business and quality management system.
• Excellent interpersonal skills and ability to build strong working relationships with internal departments, contractors, suppliers, and external stakeholders.

SF Bay Area Salary Range

$155,000 — $209,000 USD

Company Culture

At Outset, we believe every person matters. Every Outsetter, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with intelligent speed. Our team expects nothing less than our best display of strengths and skills, and we find joy in working together for a common goal. At Outset, we believe that curiosity, ingenuity and conviction in the power of technology will transform the lives of dialysis patients and providers.

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU, our future Outsetter. At Outset, we’ve designed a professional world that our employees are honored and impassioned to belong to, one that offers challenge, the ability to collaborate with great people, and opportunities to build skill and expertise in a fulfilling career.

An opportunity at Outset Medical won’t just be about finding a job. Our culture revolves around the principles of moving farther, faster, together, so working here feels like a masterclass in peak performance, for individuals and teams.

Important Notice

We have been made aware of fraudulent activities where individuals are impersonating our company and offering fake job opportunities. Please note, Outset Medical will never request payment or gift cards during the hiring process, nor will we ask you to purchase your own equipment. Anyone reaching out to you with an email address ending in .cc, is not a legitimate Outset representative. For legitimate opportunities, always apply directly through our official careers page. If you are unsure about the authenticity of a communication, contact us immediately at .