Software Verification & Validation Engineer

Neuralink-posted 2 months ago
$71,000 - $119,000/Yr
Full-time • Entry Level
Austin, TX
251-500 employees
Professional, Scientific, and Technical Services
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As a Software Verification & Validation Engineer, you will play a critical role in upholding the integrity of our software systems within a highly-regulated medical device environment. This position involves overseeing validation activities to ensure software meets FDA requirements, including 21 CFR Part 11, 21 CFR Part 820 and SaMD/SiMD guidelines, while collaborating across teams to support the development of new software tools.

  • Sustain software V&V activities ensuring ongoing compliance and performance
  • Own the software V&V program, including development, revision, and maintenance of Standard Operating Procedures
  • Serve as the subject matter expert on 21 CFR Part 11, 21 CFR Part 820, IEC 62304, and other SW Validation Standards for driving overall compliance with FDA guidelines
  • Conduct design controls, code reviews, unit tests, creation and review of sBOMs, and related activities to verify software integrity per regulatory standards
  • Act as a Quality liaison with core software teams for the development and validation of internal systems
  • Develop and own SaMD/SiMD compliance for our devices, including clinical evaluation, analytical validation, and risk management
  • Develop and execute validation protocols, test plans, scripts, and reports to document software performance, including integrated verification activities with limited supervision
  • Develop an automated V&V process for SW back-end testing
  • Perform software risk assessments and contribute to hazard mitigation strategies
  • Support regulatory audits, inspections, and submissions with comprehensive documentation
  • Validate and verify software utilized across various divisions, including custom and off-the-shelf software
  • Apply knowledge of high-level programming languages to create new test protocols, debug existing ones, and resolve issues
  • Bachelor's degree in software engineering, computer science, biomedical engineering, or a related field
  • 1+ years of experience in a regulated field performing software design, verification, or validation, preferably in the medical device or pharmaceutical industries
  • Proficiency in validation tools, scripting (e.g., Python), and code review processes
  • Excellent analytical, problem-solving, and communication skills, with the ability to collaborate across interdisciplinary teams
  • 3+ years in medical device software validation, with hands-on IEC 62304 lifecycle experience
  • Familiarity with risk management standards like ISO 14971, as well as IEC 60601 and other relevant medical device standards
  • Experience in post-market surveillance and software updates in regulated environments
  • Expertise in SaMD compliance, including FDA guidance on clinical and analytical validation
  • Hands-on experience with software development lifecycle methodologies, including Agile and SAFe
  • Proficiency with defect tracking tools (e.g., Jira) and statistical software (e.g., Minitab)
  • Experience with regulatory agencies and standards like 21 CFR 820, ISO 13485, and IEC 62304/82304
  • An opportunity to change the world and work with some of the smartest and most talented experts from different fields
  • Growth potential; we rapidly advance team members who have an outsized impact
  • Excellent medical, dental, and vision insurance through a PPO plan
  • Paid holidays
  • Commuter benefits
  • Meals provided
  • Equity (RSUs) *Temporary Employees & Interns excluded
  • 401(k) plan *Interns initially excluded until they work 1,000 hours
  • Parental leave *Temporary Employees & Interns excluded
  • Flexible time off *Temporary Employees & Interns excluded
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