Hiring: Quality Engineer, Software Design Controls Company: Neuralink Location: Austin, TX Job Posted Time: 2026-09-13 10:34:28 Employment Type: Full-time Target Skills & Keywords : Firmware, Product Development Lifecycle About the job Experience: •3+ years of hands-on experience with software design controls, software quality, or software design assurance for medical devices. Required Skills: •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 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. •Debug software quality and design control gaps using requirements management tools, traceability matrices, code/architecture reviews, test results, anomaly data, and root-cause analysis techniques; recommend effective process and design mitigations. •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 across teams. Qualifications: •Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline. •In-depth knowledge 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. •Solid functional 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. •Prior experience contributing software design control or V&V data to regulatory submissions (IDE, 510(k), PMA, or equivalent) and interfacing with FDA or notified bodies. •Operational familiarity with additional standards such as IEC 62366 (usability), 21 CFR Part 11, or cybersecurity guidance (FDA, IEC 81001-5-1). •Base Salary Range:: $103,000 USD - $191,000 USD Compensation: •Excellent medical, dental, and vision insurance through a PPO plan Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!