Senior Software Design Quality Engineer

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.

Senior Software Design Quality Engineer

Why Us?

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.
 

Illumina's employee benefits are industry-leading and include, flexible time off, private medical insurance, compassion and care time off, leisure travel insurance, pension, employee stock purchasing program, volunteer time off, and much more!

Responsibilities:

• Provide technical and strategic feedback associated with IVDR software as well as RUO software and digital health aligned with applicable regulations, standards, and business needs.
• Lead the development and maintenance of the Risk Management File (RMF) including risk management plans, hazards analysis, dFMEAs, pFMEAs, and risk management report.
• Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation. Responsible for quality oversight and approval of software product development plans, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports.
• Serve as the SME for software quality and collaborate with teams on code reviews, software security analysis, defect and vulnerability triage, creation and maintenance of sBOMs, etc., and lead implementation of best practices for software quality processes.
• Participate in design reviews to ensure the effective development, transfer, and maintenance of the product throughout the product lifecycle.
• Establish and cultivate positive relationships with cross-functional stakeholders and product development team members to optimize the success of development projects.
• Support other areas of the Quality System and perform other tasks as defined by Management.
   

Required skills and experience:

• B.S./M.S. in relevant engineering field (e.g., biomedical, computer science, software, electrical, etc.) or equivalent scientific degree.
• Many years of progressive Quality Engineering experience in the medical device industry with hands-on support for software development.
• Strong solid understanding of international medical device/IVDR regulations and standards, including 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971.
• Solid 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.
• Ability to work independently and as part of team, strong collaborative skills.

Preferred skills and experience:

• Understanding of Artificial Intelligence, data management and related regulations/standards requirements.
• Experience working within an AAMI TIR45 framework/ Agile software development for the development of SaMD/Digital health.
• Experience supporting development of cloud-based software and understanding of cloud infrastructure and deployment.

What can you expect?

Our team members are bright, energetic, and dedicated - they are the driving force behind our innovation and impact. To attract the best and brightest, we offer a competitive employee benefits program. We view it as a smart investment in our people, one that recognizes the tremendous value they bring to our business every day. At Illumina, we push boundaries. We think beyond the conventional. We dream big. With the energy of so many bright and accomplished people, the opportunities are endless.

#LI-EUROPE

#LI-EMEA

#LI-REMOTE

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunities 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.