Quality Systems Engineer

About the Company

Neuralink is creating devices that enable a bi-directional interface with the brain to restore movement to the paralyzed, restore sight to the blind, and revolutionize human-digital interaction.

Responsibilities

• Design and implement scalable software design controls systems aligned with IEC 62304 and FDA requirements
• Develop and maintain end-to-end traceability frameworks linking user needs, requirements, risk controls, and design outputs
• Integrate software risk management into design controls using ISO 14971 principles
• Build change control mechanisms to support rapid iteration and parallel development
• Partner with software engineering teams to embed compliance into CI/CD pipelines and automated evidence generation
• Own Quality System subsets including Software Design Control, Risk Management, and Change Control

Requirements

• Bachelor’s degree in Electrical Engineering, Computer Science, or a related technical field
• Experience designing or maintaining structured engineering or compliance systems
• Familiarity with software development lifecycles in regulated or safety-critical environments
• Working knowledge of Design Controls and software requirements management
• Proficiency in basic scripting, automation, or querying (e.g., Python, SQL)
• Strong problem-solving and systems thinking skills

Preferred Qualifications

• Familiarity with IEC 62304, FDA Design Controls (21 CFR 820.30), and ISO 14971
• 1–3 years of experience in Design Controls, Software Quality, or regulated software development