Software Design Control Engineer

Neuralink • Austin, TX

3h • $71,000 - $119,000

About The Position

Neuralink is creating devices that enable a bi-directional interface with the brain, aiming to restore movement to the paralyzed, sight to the blind, and revolutionize human interaction with the digital world. The Quality Systems Team focuses on ensuring compliance with applicable regulatory standards by designing scalable, efficient, and automation-driven systems. They embed compliance directly into engineering workflows, applying systems thinking and creative problem-solving to build a durable compliance infrastructure that supports rapid development. Their vision is to establish internal design and quality systems that exceed FDA expectations while enabling fast iteration and deployment of complex, safety-critical software products.

Requirements

• Bachelor’s degree in Electrical Engineering, Computer Science, or a 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
• Working knowledge of Software requirements management
• Proficiency in basic scripting, automation, or querying (e.g., Python, SQL, or equivalent)
• Excellent written and verbal communication skills
• Strong problem-solving mindset with the ability to think in systems rather than silos

Nice To Haves

• Familiarity with IEC 62304 (Medical Device Software Lifecycle Processes)
• Familiarity with FDA Design Controls (21 CFR 820.30)
• Familiarity with Design Risk Management (ISO 14971 principles)
• 1–3 years of experience in Software Design Controls Engineer role
• 1–3 years of experience in Software Quality
• 1–3 years of experience in Regulated software development

Responsibilities

• Design and implement scalable software design controls systems aligned with IEC 62304 and FDA design control requirements (21 CFR 820.30)
• Develop and maintain end-to-end traceability frameworks linking user needs, software requirements, risk controls, design outputs (code, architecture), and verification and validation evidence
• Integrate software risk management into design controls, ensuring alignment with ISO 14971 principles
• Build change control mechanisms capable of supporting rapid iteration, parallel development, and same-day deployment
• Partner closely with software engineering teams to embed compliance with CI/CD pipelines, automated evidence generation, and controlled release processes
• Own subsets of the Quality System related to software design controls, including Software Design Control processes, Software Risk Management, Software Change Control, and Software Verification & Validation traceability

Benefits

• Excellent medical, dental, and vision insurance through a PPO plan
• Paid holidays
• Commuter benefits
• Meals provided
• Equity (RSUs) for full-time employees
• 401(k) plan for full-time employees (Interns initially excluded until they work 1,000 hours)
• Parental leave for full-time employees
• Flexible time off for full-time employees

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level