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Sr. Software Design Quality Engineer

A genomics technology company expanding access to genomic technology to realize health equity worldwide through early disease detection and diagnosis.
Senior Software Engineer
Remote
5,000+ Employees
8+ 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 security and quality throughout the product lifecycle.

The ideal candidate will bring extensive experience in Quality Engineering within the medical device industry, combined with a strong understanding of international regulations and standards. This is not a traditional software testing role, but rather a senior position focused on quality assurance and regulatory compliance in software development.

At Illumina, you'll be part of a company that's expanding access to genomic technology to improve human health worldwide. Their technology enables life-changing discoveries in disease detection, diagnosis, and treatment options. The company offers comprehensive benefits including flexible time off, medical insurance, and equity participation through their stock purchase program.

The role offers an opportunity to make a significant impact on healthcare technology while working with cutting-edge genomic applications. You'll be responsible for maintaining quality standards, reviewing design documentation, and ensuring regulatory compliance across software development projects. The position requires both technical expertise and leadership skills, as you'll be working with various teams and stakeholders throughout the organization.

This is an excellent opportunity for a senior professional looking to combine software quality expertise with healthcare innovation in a remote working environment. The role offers the chance to work on meaningful projects that directly impact patient care while being part of a global leader in genomic technology.

Last updated 20 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 progressive 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
  • Strong collaborative skills
  • Ability to work independently in fast-paced environment

Benefits For Sr. Software Design Quality Engineer

Medical Insurance
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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