---
title: 'Quality Engineer, Software Design Controls at Neuralink'
canonical: 'https://feeny.ai/job/quality-engineer-software-design-controls-neuralink-austin-texas-te3sfxz9d8a1'
type: 'job'
last_seen: '2026-09-04'
---

# Quality Engineer, Software Design Controls at Neuralink

- **Company:** Neuralink
- **Location:** Austin Texas, United States
- **Compensation:** $103k–$191k
- **Posted:** 2026-08-21
- **Last confirmed live:** 2026-09-04
- **Apply:** https://boards.greenhouse.io/neuralink/jobs/7931610003?gh_jid=7931610003

## Job description

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 Translational Team, where we generate the data that advances Neuralink’s brain–computer interface technologies from research and development through clinical evaluation and into market implementation. We produce the rigorous evidence required to support rapid development, regulatory progress, and the safe, effective delivery of the technology to patients.

Job Description and Responsibilities:

The Quality Engineer, Software Design Controls will own software design control strategy, processes, documentation, and continuous improvement across implantable electronics software, surgical robotics software, external systems, and related non-product software. Responsibilities include:

- Work directly with software and firmware teams to identify design control and software lifecycle risks early, drive robust mitigations, and support design reviews to embed strong design control and IEC 62304 practices.
- Own software design control impact assessments for design changes within the medical device design control process; evaluate effects on requirements, architecture, risk controls, verification/validation, and traceability; determine re-test, analysis, or documentation needs; and update risk assessments, protocols, and Design History File (DHF) content to maintain ongoing compliance.
- Own end-to-end software design control strategy and plan/execute activities supporting the full software lifecycle (requirements, architecture, detailed design, implementation, verification, validation, risk management, and release) for Class III and other regulated software in accordance with IEC 62304, ISO 14971, ISO 13485, and related standards.
- Debug software quality and design control gaps using requirements management tools, traceability matrices, code/architecture reviews, test results, anomaly data, and root-cause analysis techniques; recommend effective process and design mitigations.
- Develop, execute, and maintain software design control deliverables including design and development plans, software requirements specifications, architecture documents, verification/validation plans and reports, risk management files, traceability matrices, change control records, and requirement-to-test linkages for complex systems involving implants, chargers, robots, and supporting software.
- Stay current with advancements in medical device software standards, regulatory science, and related technologies; contribute to continuous improvement of compliance processes, SOPs, templates, and knowledge sharing across teams.

Required Qualifications:

- Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline.
- 3+ years of hands-on experience with software design controls, software quality, or software design assurance for medical devices.
- Strong understanding of the software development lifecycle (SDLC) in regulated or safety-critical environments and practical application of design controls.
- Direct experience planning, executing, reviewing, and documenting software design control and verification/validation activities.
- Working knowledge of IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk Management), and ISO 13485.
- Strong cross-functional communication skills and ability to drive issues to closure across engineering, quality, regulatory, and external partners.

Preferred Qualifications:

- Experience with implants, surgical robotics, wireless systems, or Software as a Medical Device (SaMD) / Software in a Medical Device (SiMD).
- Prior experience contributing software design control or V&V data to regulatory submissions (IDE, 510(k), PMA, or equivalent) and interfacing with FDA or notified bodies.
- Experience with medical device design controls, ISO 14971 risk management (including software FMEA / SFMEA), cybersecurity risk assessment, and product development lifecycle in a regulated environment.
- Experience developing software design control guidelines, training programs, templates, or compliance workflows that accelerate product development.
- Familiarity with additional standards such as IEC 62366 (usability), 21 CFR Part 11, or cybersecurity guidance (FDA, IEC 81001-5-1).
- Experience writing test protocols, reports, deviations, engineering rationales, risk assessments, and requirement traceability in a regulated or quality-controlled development process.

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: $103,000—$191,000 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

## About Neuralink

## Company Overview
- **One-liner**: Neuralink develops implantable brain-computer interfaces (BCIs) that decode neural signals to restore autonomy for people with paralysis and other neurological conditions.
- **Entity Type**: Private (Series D; total funding $1.35B as of Aug 2025)
- **Headquarters**: Fremont, California, United States
- **Founded**: 2016
- **Founders**: Elon Musk, Max Hodak, Benjamin Rapoport, Dongjin Seo, Paul Merolla, Philip Sabes, Timothy J. Gardner, Tim Hanson, Vanessa Tolosa

## Core Business
- Primary industry: Neurotechnology / Biotechnology (implantable medical devices)
- Target customers: B2C (patients with quadriplegia, ALS, spinal cord injury), B2B (hospitals, research institutions, clinical partners)
- Mission: "Building brain interfaces to restore autonomy" – initially helping people with unmet medical needs control computers and robotic arms with their thoughts, and ultimately unlocking human potential.

## Products & Services
- **N1 Implant (“the Link”)**: Coin-sized, surgically implanted BCI that records and stimulates brain activity via flexible neural threads. Enables users to control digital devices (mouse, keyboard, apps) using thought alone. Available only in clinical trials (PRIME Study).
- **Telepathy**: Product name for the N1 Implant’s capability to allow users to control computers and mobile devices (announced by Musk).
- **Blindsight**: Experimental implant designed to restore visual perception by directly stimulating the visual cortex. Received FDA Breakthrough Device Designation in September 2024.
- **Speech BCI**: Device under development to restore communication for individuals with severe speech impairment (ALS, stroke, etc.). Received FDA Breakthrough Device Designation in May 2025.
- **Neurosurgical Robot**: Custom robot for autonomous, precise insertion of neural threads during surgery.

## Market Standing
- **Valuation**: ~$9 billion (per Tracxn, as of 2026)
- **Key Metric**: Total funding ~$1.35 billion (13 rounds); annual revenue ~$20 million (pre-commercial, primarily from research partnerships)
- **Notable Investors/Partners**: Founders Fund (led Series D), CoreNest Capital (led 2025 venture round), Elon Musk (owns >50%). Partners include University Health Network (Toronto), FDA (regulatory collaboration).
- **Growth Signals**:
  - 21 human patients implanted as of January 2026
  - Headcount grew 31.3% year-over-year to ~400 employees (with 127 active job postings)
  - Received FDA Breakthrough Device Designations for Blindsight and speech BCI
  - Expanded clinical trials to Canada (first procedures outside the U.S. in Aug/Sep 2025)
  - Patients reached typing speeds of up to 40 words per minute and achieved information transfer rates comparable to able-bodied mouse users

## Competitive Advantages
- **First-mover with human implants**: Only BCI company with FDA-approved human trials and over 20 implanted patients.
- **Robotic precision**: Proprietary surgical robot capable of inserting ultra-thin threads (4–6 µm) that are too fine for human hands.
- **Regulatory momentum**: Multiple FDA Breakthrough Device Designations accelerating development for vision, speech, and motor restoration.
- **Interdisciplinary talent pool**: Recruits from Tesla, SpaceX, OpenAI, Stanford, UCSF; team spans neuroscience, electrical engineering, robotics, and microfab.
- **High-profile leadership**: Elon Musk’s visibility draws talent, funding, and media attention.

## Strategic Focus
- **Clinical expansion**: Scale the PRIME Study to more patients and new sites (Canada, additional countries).
- **Product pipeline**: Commercialize Blindsight (vision) and speech prosthetics; develop motor/sensory restoration capabilities.
- **Regulatory pathway**: Transition from trial-only to eventual commercial approval by the FDA.
- **R&D**: Advance silent speech interfaces, cognitive enhancement, and broader neurological applications (epilepsy, depression, etc.).

## Why Work Here
- **Mission-driven impact**: Work directly on technology that restores function and independence to people with paralysis, ALS, and blindness.
- **Rapid growth**: 31% annual headcount increase; employees often advance quickly due to cross-functional, ambitious projects.
- **Culture**: Open communication and collaboration champion “the best ideas, regardless of where they come from” ([neuralink.com/careers](https://neuralink.com/careers/)).
- **Disciplines welcome**: Engineering (embedded, software, optical, analog IC), surgery/robotics, neuroscience, manufacturing, and operations.
- **Perks & environment**: Fremont HQ with plans for a larger facility near Austin. Hands-on, lab-heavy work likely requires on-site presence.
- **Career development**: Internal growth opportunities, exposure to cutting-edge science, and cross-team collaboration.

## Sources
1. [neuralink.com](https://neuralink.com/)
2. [neuralink.com/careers](https://neuralink.com/careers/)
3. [linkedin.com/company/neuralink](https://www.linkedin.com/company/neuralink)
4. [tracxn.com/d/companies/neuralink](https://tracxn.com/d/companies/neuralink/__oUVI98zbdmLZga1LgBRb3oGJJBxjbzTc7bMWUfAOLws)
5. [builtin.com/hardware/what-is-neuralink](https://builtin.com/hardware/what-is-neuralink)

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