Software Design Quality Engineer

📋 Description

• • At Foresight Diagnostics, a part of Natera, Inc., software is the critical foundation for our groundbreaking MRD (Minimal Residual Disease) detection platform, designed to identify cancer recurrence in patients. We are seeking a highly motivated and detail-oriented Software Design Quality Engineer to ensure the integrity, reliability, and scalability of our sophisticated software systems. This role is pivotal in upholding the stringent quality standards required for medical diagnostic software, directly impacting patient care and outcomes.
• • As a Software Design Quality Engineer, you will be an integral quality partner, collaborating closely with cross-functional teams including clinical laboratory personnel, Research and Development (R&D), bioinformatics specialists, product development, and regulatory affairs. Your primary responsibility will be to champion design quality throughout the entire software development lifecycle (SDLC), from initial concept and risk assessment to design reviews, verification and validation (V&V), and ongoing post-market surveillance.
• • You will play a key role in reviewing and approving essential design artifacts. This includes meticulously examining requirements documents, detailed design specifications, code review outcomes, and comprehensive verification and validation test plans and reports. Your thoroughness ensures that all software outputs align with intended use and regulatory expectations.
• • A core function of this position is to guarantee that all software design controls adhere strictly to international standards such as IEC 62304 (Medical device software – Software life cycle processes), ISO 13485 (Medical devices – Quality management systems), and other relevant regulatory guidance. The emphasis will be on demonstrating compliance through robust documentation and processes, rather than assuming it.
• • You will be instrumental in developing, implementing, and maintaining sophisticated risk analysis tools and comprehensive risk management plans for Foresight’s diverse suite of software systems. This proactive approach to risk mitigation is crucial for ensuring product safety and efficacy.
• • Furthermore, you will be responsible for creating and revising Standard Operating Procedures (SOPs) that clearly define software quality and release readiness criteria. You will guide these critical documents through the established design and documentation control processes, ensuring consistency and adherence.
• • This role involves supporting and leading cross-functional teams in planning and executing validation efforts for software systems. You will coordinate with various departments to ensure the timely identification and remediation of any compliance gaps, maintaining a high level of regulatory adherence.
• • You will actively manage the Non-Conformance Report (NCR) and Corrective and Preventive Action (CAPA) processes. This includes thoroughly investigating and resolving end-user issues, meticulously tracking relevant metrics, and ensuring that all corrective actions are effectively closed, creating a loop of continuous improvement.
• • Supporting adherence to cybersecurity best practices and frameworks across the product portfolio is another key aspect of this role, ensuring the protection of sensitive patient data and system integrity.
• • You will actively participate in external audits conducted by regulatory bodies such as CAP (College of American Pathologists), CLIA (Clinical Laboratory Improvement Amendments), and ISO certification bodies, representing the company's commitment to quality and compliance.
• • Continuous monitoring of process efficiency through internal audits will be undertaken, with the generation of reports designed to drive tangible improvements in our quality systems and development practices.
• • This position offers a unique opportunity to work at the forefront of molecular diagnostics, contributing directly to a platform that empowers oncologists and improves patient lives. You will have the autonomy to drive significant quality enhancements, supported by a dedicated team and the extensive resources of Natera, Inc.