Quality Systems Engineer

About the role

About Neuralink:

We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.

Team Description:

Join the Quality Systems Team, where our mission is to ensure compliance with applicable regulatory standards by designing scalable, efficient, and automation-driven systems. We focus on embedding compliance directly into engineering workflows rather than treating it as a manual or reactive function.

We are a team of industry-experienced professionals who apply systems thinking and creative problem-solving to build a durable compliance infrastructure that supports rapid development. Our 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.

Job Description and Responsibilities:

As a Quality Systems Engineer (dedicated towards Design Controls), your primary responsibility will be to design, implement, and continuously improve software-focused design control systems with regulatory compliance embedded into their architecture.

You will build systems that eliminate ambiguity, reduce manual effort, and enable rapid and reliable development of regulated medical device software. These systems will support the full software lifecycle, from requirements definition through verification, validation, risk management, and release.

You will continuously optimize these systems to improve speed, traceability, and audit readiness while supporting aggressive development timelines and frequent design changes. Your responsibilities include, but are not limited to:

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)

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

Same-day deployment

Partner closely with software engineering teams to embed:

Compliance with CI/CD pipelines

Automated evidence generation

Controlled release processes

Own subsets of the Quality System related to software design controls, including but not limited to:

Software Design Control processes

Software Risk Management

Software Change Control

Software Verification & Validation traceability

Required Qualifications:

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

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

Preferred Qualifications:

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:

Design Controls

Software Quality

Regulated software development

Expected Compensation:

The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees’ success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.

Base Salary Range:
$71,000 $119,000 USD

What We Offer:

Full-time employees are eligible for the following benefits listed below.

An opportunity to change the world and work with some of the smartest and most talented experts from different fields

Growth potential; we rapidly advance team members who have an outsized impact

Excellent medical, dental, and vision insurance through a PPO plan

Paid holidays

Commuter benefits

Meals provided

Equity (RSUs) *Temporary Employees & Interns excluded

401(k) plan *Interns initially excluded until they work 1,000 hours

Parental leave *Temporary Employees & Interns excluded

Flexible time off *Temporary Employees & Interns excluded