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Quality Engineer, Software Design Controls

Neuralink· Translational
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Full-timePosted 2mo ago

About the role

Quality Engineer responsible for software design control strategy, processes, and documentation across implantable electronics software, surgical robotics software, external systems, and related non-product software, ensuring IEC 62304, ISO 14971, and ISO 13485 compliance for Class III and other regulated software.

Responsibilities

  • Own software design control strategy, processes, documentation, and continuous improvement across implantable electronics software, surgical robotics software, external systems, and related non-product software.

Qualifications

  • 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 and practical application of design controls.
  • Direct experience planning, executing, reviewing, and documenting software design control and verification/validation activities.
  • Working knowledge of IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk Management), and ISO 13485.
  • Strong cross-functional communication skills and ability to drive issues to closure across engineering, quality, regulatory, and external partners.

Skills

Required:Software design controls

Benefits

  • Excellent medical, dental, and vision insurance through a PPO plan
  • Paid holidays
  • Commuter benefits
  • Meals provided
  • Equity (RSUs) for all full-time employees
  • 401(k) plan
  • Parental leave
  • Flexible time off
Last updated Aug 26, 2026. Interested? Apply on the company site.

About Neuralink

Pioneering Brain Computer Interfaces

Creating a generalized brain interface to restore autonomy to those with unmet medical needs today and unlock human potential tomorrow.

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