Creating a generalized brain interface to restore autonomy to those with unmet medical needs today and unlock human potential tomorrow. Backed by Lightspeed, Sequoia and Founders Fund.
About the role
The Quality Engineer, Software Design Controls will own software design control strategy, processes, documentation, and continuous improvement across implantable electronics software, surgical robotics software, external systems, and related non-product software. Responsibilities include:
What they're looking for
- 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
More about this role
We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.
Join the Translational Team, where we generate the data that advances Neuralink’s brain–computer interface technologies from research and development through clinical evaluation and into market implementation. We produce the rigorous evidence required to support rapid development, regulatory progress, and the safe, effective delivery of the technology to patients.
The Quality Engineer, Software Design Controls will own software design control strategy, processes, documentation, and continuous improvement across implantable electronics software, surgical robotics software, external systems, and related non-product software. Responsibilities include:
- Work directly with software and firmware teams to identify design control and software lifecycle risks early, drive robust mitigations, and support design reviews to embed strong design control and IEC 62304 practices.
- Own software design control impact assessments for design changes within the medical...
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