Tech Stack

Description

You will design, implement, and continuously improve software-focused design control systems with regulatory compliance embedded into their architecture, supporting the full software lifecycle for medical device software at Neuralink.

Requirements

• Bachelor's degree in Electrical Engineering, Computer Science, or related technical field
• Demonstrated 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 Python, SQL, or equivalent scripting/automation/querying

Responsibilities

• Design and implement scalable software design controls systems aligned with IEC 62304 and FDA 21 CFR 820.30
• Develop and maintain end-to-end traceability frameworks linking user needs, software requirements, risk controls, design outputs, and verification/validation evidence
• Integrate software risk management into design controls, ensuring alignment with ISO 14971 principles
• Build change control mechanisms supporting rapid iteration, parallel development, and same-day deployment
• Partner with software engineering teams to embed compliance with CI/CD pipelines, automated evidence generation, and controlled release processes