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Sr. Software Design Quality Engineer

A genomics technology company expanding access to genomic technology to realize health equity for billions of people worldwide.
Senior Software Engineer
Remote
5,000+ Employees
5+ years of experience
Healthcare · Biotech

Job Description

Illumina is seeking a Senior Software Design Quality Engineer to join their team in a remote capacity from the UK, Spain, or Italy. This role is crucial in ensuring compliance of software with IVDR and RUO regulations while leading risk management activities. The position involves collaborating with cross-functional teams to drive best practices in software quality and security throughout the product lifecycle. Illumina is at the forefront of genomic technology, enabling life-changing discoveries that transform human health through early disease detection and new treatment options. The ideal candidate will have extensive experience in medical device software quality engineering, strong knowledge of international regulations, and the ability to work independently while collaborating effectively with teams. This role offers the opportunity to make a significant impact on healthcare technology while working for a company that values innovation and employee development. The position comes with comprehensive benefits and the flexibility of remote work, making it an attractive opportunity for experienced quality engineers looking to contribute to meaningful healthcare solutions.

Last updated 7 days ago

Responsibilities For Sr. Software Design Quality Engineer

  • Provide technical and strategic feedback for IVDR and RUO software aligned with regulations
  • Lead development and maintenance of Risk Management File (RMF)
  • Provide Quality Engineering input and approval of Design History File (DHF)
  • Serve as SME for software quality and collaborate on code reviews and security analysis
  • Participate in design reviews throughout product lifecycle
  • Establish relationships with cross-functional stakeholders
  • Support Quality System and perform management-defined tasks

Requirements For Sr. Software Design Quality Engineer

  • B.S./M.S. in relevant engineering field or equivalent scientific degree
  • Many years of Quality Engineering experience in medical device industry
  • Strong understanding of medical device/IVDR regulations and standards
  • Solid understanding of software development best practices for digital health
  • Organized self-starter able to work in fast-paced environment
  • Strong collaborative skills
  • Experience with Artificial Intelligence and data management preferred
  • Experience with AAMI TIR45 framework/Agile software development preferred
  • Experience with cloud-based software development preferred

Benefits For Sr. Software Design Quality Engineer

Medical Insurance
Dental Insurance
Vision Insurance
401k
Equity
  • Flexible time off
  • Private medical insurance
  • Compassion and care time off
  • Leisure travel insurance
  • Pension
  • Employee stock purchasing program
  • Volunteer time off

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