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Quality Engineer, Software Design Controls

Neuralink
Location
Austin, Texas, United States
Posted
1 month ago
Department
Translational
What they actually want (must-haves)
  • Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline
  • 3+ years of hands-on experience with software design controls, software quality, or software design assurance for medical devices
  • Strong understanding of the software development lifecycle (SDLC) in regulated or safety-critical environments
  • Direct experience planning, executing, reviewing, and documenting software design control and verification/validation activities
  • Working knowledge of IEC 62304, ISO 14971, and ISO 13485
  • Strong cross-functional communication skills
Nice to have
  • Experience with implants, surgical robotics, wireless systems, or Software as a Medical Device (SaMD) / Software in a Medical Device (SiMD)
  • Prior experience contributing software design control or V&V data to regulatory submissions and interfacing with FDA or notified bodies
  • Experience with medical device design controls, ISO 14971 risk management, cybersecurity risk assessment, and product development lifecycle in a regulated environment
  • Experience developing software design control guidelines, training programs, templates, or compliance workflows
  • Familiarity with additional standards such as IEC 62366, 21 CFR Part 11, or cybersecurity guidance
What the job really is

As a Quality Engineer in Software Design Controls at Neuralink, you will be responsible for overseeing software design control strategies and processes for medical devices. Your day-to-day tasks will include collaborating with software teams to identify risks, managing design control documentation, and ensuring compliance with medical device standards throughout the software lifecycle.

Benefits
  • Excellent medical, dental, and vision insurance through a PPO plan
  • Paid holidays
  • Commuter benefits
  • Meals provided
  • Equity (RSUs)
  • 401(k) plan
Things to weigh
  • Base salary range is quite broad, which may lead to variability in compensation based on negotiation
  • Role involves significant regulatory compliance responsibilities, which may be stressful
  • No specific mention of remote work options or work-life balance initiatives
Job score3.4/5
Benefits4/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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