Software Design Quality Engineer

Foresight Diagnostics, now part of Natera, Inc, is a molecular diagnostics company focused on non-invasive cancer detection technologies. The Software Design Quality Engineer will ensure that software systems meet regulatory standards and quality requirements throughout the software development lifecycle, collaborating with cross-functional teams to drive compliance and quality improvements.

Responsibilities:

• Leading design quality engineering activities across the software development lifecycle - from risk assessments and quality planning through design reviews, V&V, and post-market monitoring
• Reviewing and approving design input/output artifacts including requirements documents, design specifications, code reviews, and verification and validation test plans and reports
• Ensuring all software design controls are compliant with IEC 62304, ISO 13485, and other applicable regulatory guidance - and that compliance is demonstrated, not assumed
• Developing and maintaining risk analysis tools and risk management plans across Foresight’s suite of software systems
• Creating and revising SOPs to define software quality and release readiness requirements, shepherding documents through design and documentation control processes
• Supporting and leading cross-functional validation planning efforts for software systems, coordinating with teams on timely remediation of compliance gaps
• Managing NCR and CAPA processes - investigating and resolving end-user issues, tracking metrics and closing the loop
• Supporting cybersecurity process adherence across the product portfolio
• Participating in external audits with regulatory bodies including CAP, CLIA, and ISO certification bodies
• Monitoring process efficiency through internal audits and reporting that drives real improvement

Requirements:

• Minimum of 3-5 years of software quality engineering experience in a regulated environment (FDA, ISO, CAP/CLIA, or equivalent)
• Hands-on experience executing IEC 62304 software development lifecycle requirements in conjunction with ISO 13485 design controls
• Demonstrated ability to define, implement, and maintain compliant software development, execution, and documentation
• Strong autonomy and project ownership: you can drive complex, cross-functional work without waiting to be told what to do next
• Bachelor's degree in software engineering, computer science, information technology, or a closely related field
• Exceptional interpersonal and collaboration skills - you work as well with lab scientists as you do with software engineers
• Background in molecular diagnostics, oncology, or liquid biopsy (cfDNA, NGS, tumor-informed assays)
• Familiarity with cybersecurity frameworks in a regulated product context (ISO 27001)
• Experience in a Class II or III medical device environment
• Quality certifications (CQE, CSQE, or equivalent)