Neuralink · 19 hours ago
Quality Systems Engineer
Austin, Texas, United States
Full-time
Onsite
Entry, Mid Level
$71K/yr - $119K/yr
1+ years expNeuralink is creating devices that enable a bi-directional interface with the brain. The Quality Systems Engineer will design and implement software-focused design control systems ensuring regulatory compliance, optimizing these systems for rapid development of regulated medical device software.
BiotechnologyMedicalNeuroscienceRobotics
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)
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
Qualification
Required
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
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
Benefits
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
Company
Neuralink
Neuralink is a neurotechnology company that focuses on developing brain-computer interfaces designed to treat neurological disorders.
201-500 employees
H1B Sponsorship
Neuralink has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (14)
2023 (7)
2022 (5)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageTotal Funding
$1.34BKey Investors
CoreNest CapitalFounders FundVy Capital
2025-07-07Series Unknown
2025-06-17Secondary Market
2025-05-27Series E· $649M
Leadership Team
Dongjin Seo
Co-Founder, President & COO
Shivon Zilis
Director of Operations and Special Projects
Recent News
2026-01-09
Company data provided by crunchbase