Senior Quality Engineer

Organization
Helix
Job Location
1 Circle Star Way, Floor 2
San Carlos, CA 94070
Benefits

What Helix has to offer you:

Aside from working alongside brilliant, dedicated, passionate, down-to-earth, curious, warm, and thoughtful people, we also provide great benefits:

  • Competitive compensation, including meaningful equity
  • Health insurance, including medical, dental, and vision
  • 401(k) with employer matching
  • Catered meals
  • Generous PTO
  • Commuter benefits
  • Gym subsidy
Job Description

As Helix's first Quality Engineer, 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.

As a Senior Quality Engineer, you will:

  • Implement and maintain FDA Quality System Regulations (e.g., Design Controls) and software lifecycle processes in our Bioinformatics and Engineering Teams
  • Support development of medical device product, by reviewing/approving of software deliverable documents, e.g. Risk Management Plans, Design Development Plans / Software Verification and Validation Plans/ Software Requirements Specifications / Software Architecture  / Test Protocols, Requirements Trace Matrices and Reports
  • Develop and conduct training on software life cycle framework to software developers, testers and other stakeholders within the organization
  • 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

Required Background:

  • Bachelor’s degree in Computer Science, Software Engineering, Informatics, Biomedical or related technical field required
  • 5-8 years' experience with Software Quality / Software Development in an FDA regulated environment. 
  • 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
How to Apply
About Our Organization

We believe that everyone benefits from their biological information. It’s our mission to empower every person to improve their life through DNA. With our high-quality, trusted partners and state-of-the-art lab, we’ve created the first platform of personalized products and services powered by genetics. From advanced cancer screening to custom fitness and nutrition plans, the world of DNA learning is becoming more accessible and more valuable than ever.

So far we’ve raised over $100 million from investors like Illumina (the world’s leader in genetic sequencing equipment), Warburg Pincus, Sutter Hill Ventures, and Kleiner Perkins. We’ll be working with partners such as National Geographic, the Mayo Clinic, Invitae, and many others to develop applications which interpret your genome, with an app store and marketplace launching in 2017.

Our big vision comes with big responsibility. That’s why we’re building a team of experts in the field of genetics, engineering, design, business development, and beyond to help bring actionable insights to our customers. We’re looking for the best and brightest minds who are passionate about our mission and are excited to work on a truly diverse team.

Helix is headquartered in San Carlos, with our genetic sequencing lab located in San Diego.

 

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