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 Staff Systems Engineer will be leading activities that are moving genomics into clinical practice in oncology, pre-natal testing, infectious disease diagnosis, and other emerging markets. In this position, the person will focus on the execution of systems engineering activities and the generation of product development deliverables throughout the development of Illumina’s industry-leading DNA Sequencers and the commercialization of new regulated products in the worldwide markets that Illumina serves. This person will help foster the growth of the Systems Engineering function by introducing best practices, educating the department on global regulatory requirements, and expanding the capabilities of team.Responsibilities:Understand the SDLC framework. Participate as an active member on instrument software team to ensure completeness of the (DHF) Design History File and specific content required for OEM partnership.Transform operational/customer needs into technical description and design specification for a software system. Establish Design History Files for partners regulatory requirement submission.Collaborate with Regulatory Affairs and IP Legal to lead the requirement gathering process and perform requirement analysis and risk analysis, e.g., to NMPA and Cybersecurity requirement.Primary liaison to program core team members and as SE SME to coordinate inter-dependencies to fulfill overall product delivery.Verify team’s delivery against requirements to ensure the right functionality.Work with Agile scrum team to evaluate the instrument software for On-Market DNA sequencing and genotyping devices in varied manufacturing models.Assist in troubleshooting system problems during development and sustaining of product e.g., Compliance testing – Instrument Type Testing, Software Regression Testing, Vulnerability Scanning.Work and lead project teams across multiple global sites. Drive decisions and tradeoffs in regulated and non-regulated environments. Help create and mature internal design and OEM partnership processes.All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.Education and Experience:Bachelor’s or Master’s Degree in Computer Science, Computer Engineering, Bioengineering (in Engineering or Scientific discipline).With 8 years of working experience in a regulated industry on product development (preferably on Medical Devices). Knowledgeable in Instrument Software, Windows & Linux OS.Desired Profile:At least 4 years of working experience in the Life Science industry with knowledge in DNA Sequencing or at least 4 years of experience as a Business Analyst.Product Owner or working experience in regulated product development environment on medical device software (IEC62304 and ISO 13485).Working knowledge of software development projects (SW Releases, SW Environment management, SaaS, SW Integration projects) using standard methodologies (SCRUM, SAFe, Kanban, waterfall, hybrid).Experience in Requirement Definition and Architecture.Experience with a variety of risk analysis techniques i.e., FMEA, FTA within a product development environment working at the system level.Strong analytical skills, problem solving and troubleshooting. Strong verbal and written communication skills.Demonstrated experience in leading cross functional teams globally.Experience in developing instrument software / hardware integration is a plus.All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.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.
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