Job Description

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Position Summary:

The Software Quality group is a highly specialized group within Design Quality. The Software Quality Engineer 2 provides support to Illumina\xe2\x80\x99s software development teams to ensure that the company\xe2\x80\x99s product software is designed in accordance with Illumina\xe2\x80\x99s 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

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\xe2\x80\x99s, 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\xe2\x80\x99s 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

2+ years\xe2\x80\x99 experience in (software) design quality engineering or related role in a medical device / IVD company environment

Working experience with relevant industry standards (ISO 13485, ISO 14971, IEC 62304)

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.) (preferred)

Occasional travel may be required

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

Illumina