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Neuralink is seeking a Quality Engineer, Software Design Controls to own software design control strategy, processes, and documentation across implantable electronics software, surgical robotics software, external systems, and related non-product software.
You will work directly with software and firmware teams to identify design control and software lifecycle risks early, drive robust mitigations, and support design reviews embedding strong design control and IEC 62304 practices. Key responsibilities include owning software design control impact assessments for design changes within the medical device design control process, evaluating effects on requirements, architecture, risk controls, verification/validation, and traceability, and determining re-test, analysis, or documentation needs.
You will own end-to-end software design control strategy and plan/execute activities supporting the full software lifecycle (requirements, architecture, detailed design, implementation, verification, validation, risk management, and release) for Class III and other regulated software in accordance with IEC 62304, ISO 14971, ISO 13485, and related standards.
Responsibilities also include debugging software quality and design control gaps using requirements management tools, traceability matrices, code/architecture reviews, test results, and anomaly data; developing and maintaining software design control deliverables including design and development plans, software requirements specifications, architecture documents, verification/validation plans and reports, risk management files, and traceability matrices; and staying current with advancements in medical device software standards and regulatory science.
Required: Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline; 3+ years hands-on experience with software design controls, software quality, or software design assurance for medical devices; strong understanding of 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; and strong cross-functional communication skills.
Preferred: Experience with implants, surgical robotics, wireless systems, or Software as a Medical Device (SaMD); prior experience contributing software design control or V&V data to regulatory submissions (IDE, 510(k), PMA); experience with ISO 14971 risk management, cybersecurity risk assessment, and product development lifecycle in regulated environments; experience developing software design control guidelines, training programs, or compliance workflows; and familiarity with IEC 62366, 21 CFR Part 11, or cybersecurity guidance.
