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Precision medicine company dedicated to improving the lives of cancer patients through improved cancer detection methods
Software Design Quality Engineer
Location
United States
Posted
66 days ago
Salary
$85K - $100K / year
Seniority
Senior
Job Description
Software Design Quality Engineer
Foresight Diagnostics Inc.
• 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.
Job 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.
Benefits
- Medical, dental, and vision
- Flexible PTO and paid holidays
- Parental leave
- 401(k) with company match
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