Neuralink
Quality Engineer, Software Design Controls
$103K–$191K
Austin, Texas, United States · Full-time · Posted Aug 21, 2026
- Experience
- 3+ years
- Education
- Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline.
About the job
Own software design control strategy, lifecycle documentation, and continuous improvement for Neuralink’s regulated medical-device software, including implantable electronics, surgical robotics, and supporting systems.
What you'll do
- Partner with software and firmware teams to identify and mitigate design-control risks and support design reviews.
- Plan and maintain lifecycle design-control deliverables, including requirements, risk management, verification/validation, traceability, change control, and DHF documentation.
- Assess design changes and investigate software quality gaps, determining needed testing, analysis, documentation, and process improvements.
What they ask for
- Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or a related technical discipline.
- Hands-on experience with software design controls, software quality, or software design assurance for medical devices.
- Understanding of SDLC in regulated or safety-critical environments, with experience planning, executing, reviewing, and documenting design-control and verification/validation activities.
- Working knowledge of IEC 62304, ISO 14971, and ISO 13485.
Nice to have
- Experience with implants, surgical robotics, wireless systems, or SaMD/SiMD.
- Experience contributing software design-control or V&V data to regulatory submissions and interfacing with FDA or notified bodies.
Pay
$103,000 — $191,000 USD (base salary)
Tools
IEC 62304, ISO 14971, ISO 13485, IEC 62366, 21 CFR Part 11, IEC 81001-5-1
Model-written summary · the original posting is authoritative