Helix is hiring a

Sr Software Quality Eng

San Carlos, United States

Everyone can benefit from a better understanding of the most fundamental aspect of what makes them unique: their own DNA. Inside all those A’s, T’s, C’s and G’s lie insights into every person—you just have to know what you’re looking for.  With the backing from the market leader in DNA sequencing Illumina, Helix is creating the world’s first platform for consumers to get sequenced and gain these insights in their DNA through an ecosystem of high-quality partners. From personalized medicine to advanced cancer screenings to custom diet and nutrition plans, the world of DNA learning is becoming accessible and more valuable than ever. And as our partners grow, so will the opportunity for discovery.

As a Sr Software Quality Engineer, you would be the second member of Helix’s Regulatory and Quality Affairs team. You would have an integral role in implementing software device lifecycle processes and work closely with the software and bioinformatics teams to support regulatory submissions and compliance activities. This position provides a unique opportunity to make an immediate impact and lay the foundation for processes and procedures in a fast-paced dynamic environment. If you are looking for the opportunity to lead and make a significant contribution, this role provides an empowering and action-oriented environment to take your career and our mission to the next level.

If you are interested in applying your software compliance skills and knowledge to a company that is poised to bring cutting-edge technology and novel products to the market, join our team. This position is for will be located at our headquarters in San Carlos (SF Bay Area) with the clinical genetics laboratory based in San Diego.

Responsibilities:

  • Implement and maintain US FDA Quality System Regulations (e.g., Design Controls) and software lifecycle processes in our Bioinformatics Team
  • Develop and conduct training on software life cycle framework to software developers, testers and other stakeholders within the organization
  • Support Software Development projects, by reviewing/approving of software deliverables, e.g. Software Development Plans / Software Verification and Validation Plans Software Requirements Specifications / Software Architecture and Design Documents / Peer Reviews Software Risk Management Documents Test Protocols, Requirements Trace Matrices, Reports
  • Mentor and guide software teams in risk management activities, and design reviews
  • Support product transfer to production and software deployment
  • Provide CAPA support to software issues
  • Support internal and external audits and inspections
  • Other duties as determined

 

Requirements:

  • 4 to 7 years Software Quality / Software Development / Software Testing
  • Track record of implementing and improving product software related processes
  • Skilled to lead, mentor and train teams on relevant processes
  • Experience with Quality Management Systems (21 CFR 820, ISO 13485)
  • Experience with regulated environments for in vitro diagnostics/medical devices
  • Experience with and knowledge of applicable standards IEC 62304, ISO 14971
  • Experience with software engineering best practices
  • Experience with software life cycle models
  • Working knowledge of software configuration management
  • Attention to detail, strong organization skills, and ability to work independently and in teams
  • Excellent interpersonal, verbal and written communication skills
  • Ability to operate flexibly in fast-paced environment
  • Able to deliver quality outputs under minimal supervision

 

Education:

  • Bachelor’s degree in Computer Science, Software Engineering, Informatics, Biomedical or related technical field required