Senior Design Quality Engineer (Software)

Position Responsibilities:

· Own all aspects of Software Design Quality for IVDR and RUO software, including risk management, design controls, and Design History File (DHF).

· Provide Software Quality Engineering support for project planning, requirements/specification development, software verification, design verification and validation, design transfer, process development, process validation, risk management, and/or human factors.

· Own risk management activities, including the Risk Management File (RMF), risk management plan, hazard analysis, dFMEA, and risk management report.

· Serve as the SME for Software Quality Engineering and collaborate with teams on code reviews, software security analysis, defect and vulnerability triage, creation and maintenance of sBOMs, etc., and lead the implementation of best practices for software quality processes.

· Drive cross functional engagement with cross-functional stakeholders to optimize the success of development projects.

· Support audits to ensure the quality and completeness of product DHFs

· Conduct root cause investigations of product complaints and quality issues, initiate corrective actions, and monitor the implementation and effectiveness of corrective actions, when applicable.

· Support other areas of Illumina’s Quality Management System (QMS), when applicable.

Position Requirements:

· Bachelor's Degree or Master's Degree in Engineering, Bioengineering, Bioinformatics, Computer Science, or related engineering field.

· 5+ years of experience in Software Quality Engineering experience, preferably within multiomics or bioinformatics.

· Strong understanding of international medical device/IVDR regulations and standards, including 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971.

· Strong understanding of software developmental best practices for digital health software, Medical Device Data Systems, and cloud-based software/systems.

· Organized self-starter, able to work in a fast-paced environment.

· Exceptional analytical and problem-solving skills.