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Neuralink is seeking a Software Design Quality Engineer to join the Translational Team, which generates rigorous data advancing brain-computer interface technologies from R&D through clinical evaluation and market implementation. This role owns software design control strategy, processes, and documentation across implantable electronics software, surgical robotics software, external systems, and related non-product software.
Key responsibilities include:
• Partner with software and firmware teams to identify design control and software lifecycle risks early, drive robust mitigations, and support design reviews embedding strong IEC 62304 practices.
• Own software design control impact assessments for design changes, evaluating effects on requirements, architecture, risk controls, verification/validation, and traceability; determine re-test, analysis, or documentation needs; and maintain Design History File (DHF) compliance.
• Develop and execute end-to-end software design control strategy and activities supporting the full software lifecycle (requirements through release) for Class III regulated software per IEC 62304, ISO 14971, ISO 13485, and related standards.
• Debug software quality and design control gaps using requirements management tools, traceability matrices, code/architecture reviews, test results, anomaly data, and root-cause analysis; recommend process and design mitigations.
• Develop, execute, and maintain comprehensive software design control deliverables including design plans, software requirements specifications, architecture documents, verification/validation plans and reports, risk management files, traceability matrices, and change control records for complex systems involving implants, chargers, robots, and supporting software.
• Stay current with advancements in medical device software standards, regulatory science, and related technologies; contribute to continuous improvement of compliance processes, SOPs, templates, and knowledge sharing.
Required: Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or related discipline; 3+ years hands-on experience with software design controls, quality, or design assurance for medical devices; strong SDLC understanding in regulated/safety-critical environments; direct experience planning and executing design control and V&V activities; working knowledge of IEC 62304, ISO 14971, ISO 13485; strong cross-functional communication skills.
Preferred: Experience with implants, surgical robotics, wireless systems, or SaMD/SiMD; prior regulatory submission experience (IDE, 510(k), PMA); medical device design controls and risk management expertise; experience developing design control guidelines or compliance workflows; familiarity with IEC 62366, 21 CFR Part 11, or cybersecurity guidance; experience writing test protocols, reports, and requirement traceability in regulated environments.
