Sr Software Quality Engineer Job at Hydrogen Group, San Diego, CA

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  • Hydrogen Group
  • San Diego, CA

Job Description

Job Title: SR Software Quality Engineer


Location: San Diego, CA (Hybrid)


Schedule: Standard Office Hours


Duration: 2-Month Contract


Pay Rate Range: $42.50 - $53.25/hour

Job Summary:

The Software Quality Engineer will be responsible for ensuring software compliance with international regulatory and quality standards across research-use-only (RUO) and IVDR-regulated software. This role includes risk management, design controls, Design History File (DHF) management, and supporting software development best practices to drive compliance, reliability, and continuous improvement.

Job Responsibilities:

  • Lead all aspects of Software Design Quality for IVDR and RUO software, including design controls, risk management, and DHF ownership.
  • Provide Software Quality Engineering support for project planning, requirements development, software verification, design validation, design transfer, process development, process validation, and human factors activities.
  • Manage risk management activities, including creation and maintenance of RMFs, risk plans, hazard analyses, dFMEAs, and risk reports.
  • Serve as subject matter expert (SME) for Software Quality Engineering, supporting code reviews, software security analysis, vulnerability triage, and sBOM development/maintenance.
  • Lead implementation of best practices for software quality processes across development teams.
  • Support audits to ensure completeness and compliance of DHFs.
  • Conduct root cause investigations of complaints and software-related quality issues; initiate and monitor corrective actions for effectiveness.
  • Support other aspects of the Quality Management System (QMS) as needed.

Knowledge & Skills:

  • Strong understanding of international medical device/IVDR regulations and standards, including 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971.
  • Deep knowledge of software development best practices for digital health, Medical Device Data Systems, and cloud-based platforms.
  • Exceptional analytical, problem-solving, and documentation skills.
  • Excellent verbal and written communication abilities with strong stakeholder collaboration skills.
  • Organized self-starter able to manage competing priorities in a fast-paced environment.

Education & Experience:

  • Bachelor's or Master's degree in Engineering, Bioengineering, Bioinformatics, Computer Science, or related field.
  • 5+ years of Software Quality Engineering experience, ideally in multiomics, bioinformatics, or digital health software development.

...

Job Tags

Contract work, Work at office,

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