The Illumina Global Software Quality Engineering team is looking for a Software Quality Engineer I to provide support to Illumina's software development teams to ensure that the company's product software is designed in accordance with Illumina's policies/ procedures and applicable regulations (e.g. FDA) and ISO standards.

This is not a software testing position.

Tasks And Responsibilities

• Provide quality support to new and sustaining product development teams focusing on software life cycle processes within design control. This includes design, verification, validation, risk management, software configuration management and deployment including reviews and approvals
• Drive software risk management activities in accordance with industry standards
• Help identify and resolve risks or vulnerabilities that exist in the system in order to reduce the chance of cybersecurity breaches or failures.
• Ensure our development teams are properly implementing security features
• Ensure quality and completeness of design history files for software
• Develop and conduct training on software life cycle framework to software developers, testers and other stakeholders within the organization
• Participate in strategic/technical discussions and risk-based decision making
• Ensure SLC processes meet quality and regulatory requirements and identify areas and opportunities to improve quality system processes
• Support post market activities related to product software anomalies - Complaint Handling, MDR's, CAPAs
• Trend, analyze, and report on quality data to improve product and process
  
  

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Preferred Education

• Bachelor's degree in Computer Science, Software Engineering, Bio-Informatics, Biomedical or related discipline
  
  

Preferred Requirements

• Working knowledge of product development, and specifically software development (SDLC) processes, Software Engineering Best Practices
• 1 year experience in (software) design quality engineering or related role in a medical device / IVD company environment preferred. Entry level candidates are welcome to apply.
• Working experience with relevant industry standards (ISO 13485, ISO 14971, IEC 62304)
• Experience with security process, FDA Security guidance, AAMI TIR 57, and NIST standards
• Able to deliver quality output under some supervision and with general direction
• Ability to operate flexibly in a fast-paced environment
• Partners with other functions (Product Development, Testing, Validation, etc.) to drive a culture of Quality
• Works to identify, correct, and prevent obstacles in assurance of product software quality
• Good interpersonal, verbal and written communication skills
• Apply Quality Engineering principles (structured development process, risk management, etc.) effectively
• Quality and/or Regulatory Certifications (ASQ, RAPS, AAMI, etc.)