Quality Engineer, Software Design Controls at Neuralink

The role

The Quality Engineer for Software Design Controls manages software compliance and strategy across implantable electronics, robotics, and external systems. This role involves working closely with engineering teams to embed robust design control practices and ensure regulatory alignment for Class III medical devices.

What you'll do

• Identify design control and software lifecycle risks early to drive robust mitigations.
• Perform impact assessments for software design changes within the medical device process.
• Execute end-to-end software design control activities following IEC 62304 and ISO 13485.
• Debug software quality gaps using requirements management tools and root-cause analysis.
• Maintain design history file content including specifications, risk management, and traceability.
• Contribute to the continuous improvement of compliance processes and standard operating procedures.

What you'll bring

• Bachelors degree in Computer Science or a related technical engineering discipline.
• Three or more years of experience in medical device software design controls.
• Strong understanding of the software development lifecycle in safety-critical environments.
• Practical knowledge of IEC 62304 and ISO 14971 risk management standards.
• Proven ability to drive cross-functional issues to closure with engineering and quality teams.

Your impact

This role will directly accelerate the development and regulatory progress of Neuralink’s brain-computer interface technologies. By ensuring rigorous software quality and compliance, the engineer supports the safe and effective delivery of life-changing medical devices to patients.