Staff Systems Engineer

5 days ago


Singapur, Singapore Illumina Full time
Join Illumina's Team as a Staff Systems Engineer

At Illumina, we are revolutionizing human health by expanding access to genomic technology. As a Staff Systems Engineer, you will play a critical role in leading activities that move genomics into clinical practice in oncology, pre-natal testing, infectious disease diagnosis, and other emerging markets.

Key Responsibilities:
  • Develop and execute systems engineering activities to ensure the completeness of the Design History File and compliance with OEM partnership requirements.
  • Transform operational and customer needs into technical descriptions and design specifications for software systems.
  • Collaborate with Regulatory Affairs and IP Legal to lead the requirement gathering process and perform requirement analysis and risk analysis.
  • 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 teams to evaluate 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.
Requirements:
  • Bachelor's or Master's Degree in Computer Science, Computer Engineering, Bioengineering, or related field.
  • 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 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.

Illumina is 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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