Job Title: Senior Software Quality Engineer Location: Remote candidates welcome with a preference for San Diego-based or hybrid employees. Company Overview: At Siro Diagnostics, we are revolutionizing molecular diagnostics by developing cutting-edge, point-of-care solutions. Founded in 2024 and headquartered in San Diego, Siro is a Series A startup designing and manufacturing innovative diagnostic devices that empower healthcare providers with fast, accurate, and reliable results. Our current pipeline of assays will lay the foundation for a broader portfolio of diagnostics to address critical healthcare needs. With a strong focus on research and development, Siro is shaping the future of diagnostic technology, ensuring it remains adaptable and effective for evolving global healthcare challenges. We're a team of talented individuals inspired by our mission to deliver impactful solutions. At Siro, we value trust, collaboration, and innovation. Join us as we build a company that's making a real difference--where every role contributes directly to improving patient care and shaping the future of diagnostics. Job Description: As a Senior Data Software Quality Engineer, you'll play a vital rolein ensuring the integrity and security of Medical Device Software. In this position, you will focus on supporting the Design Control and Risk Management of medical device software, ensuring compliance to standards for Quality Management System and Regulations. This position is not a software and test role. Position Responsibilities Provide quality engineering support throughout the Software Development Lifecycle (SDLC)process for medical device software. Apply design controls and Risk Management principles to NPD. Owner of quality deliverables for SW Risk Management file(s) (Software Hazard Analysis). Support software product development, design control, and design transfer processes, as well as responsibility for quality deliverables during product development. Provide quality engineering support on cybersecurity deliverables. Review software systems design, change specifications, and plans against process requirements. Participate in software development activities, not limited to code reviews, requirements review, and configuration management. Provide or direct verification and validation of software system requirements, traceability, and testability. Evaluate design and process changes and ensure that corrective measures meet acceptable standards, and that documentation is compliant with requirements. Defines appropriate measures to ensure product quality. Must be able to work independently with minimal supervision. Desired Skills & Qualifications Bachelor's degree in Engineering (e.g. electrical, biomedical, computer science) or a technical field with 5 years of experience in SW Quality Engineering in a regulated environment. Advanced degree in Engineering (e.g. electrical, biomedical, computer science) or a technical field with 3 years of experience in SW Quality Engineering in a regulated environment. Experience with web, mobile, and firmware preferred. Working knowledge in medical device software development (IEC 62304) Working knowledge in risk management (ISO 14971) Working knowledge with medical device design controls (ISO 13485) SQ certification (e.g. CSQE) preferred. Working knowledge in medical device cybersecurity (e.g. AAMI TIR57, ISO 270001) is a plus. Physical Requirements: Prolong periods of sitting at a desk and working on a computer. Repeating motions that may include the wrings, hands and/or fingers. Pay Range: The salary range for this position is $105,000-$125,000. Additionally, individuals may be eligible for an annual discretionary bonus. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. Siro Diagnostics offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation and more. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, disability, or protected veteran status. Job Type: Full-time Pay: $105,000.00 - $125,000.00 per year Benefits: 401(k) Dental insurance Health insurance Health savings account Paid time off Parental leave Vision insurance Compensation Package: Bonus opportunities Stock options Schedule: Monday to Friday Work Location: Remote