Neuralink
Quality Systems Engineer
Austin, Texas, United States · Contract
Sponsorship not specified$71k-$119kDetected 29 days ago
PythonSQLCI/CDComplianceSystems EngineeringElectrical EngineeringControlsFDA RegulatoryMedical DevicesCommunicationProblem Solving
About the role
- These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.
- We focus on embedding compliance directly into engineering workflows rather than treating it as a manual or reactive function.
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 continuously optimize these systems to improve speed, traceability, and audit readiness while supporting aggressive development timelines and frequent design changes.
- These systems will support the full software lifecycle, from requirements definition through verification, validation, risk management, and release.
- 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:
- Integrate software risk management into design controls, ensuring alignment with ISO 14971 principles
- Build change control mechanisms capable of supporting:
- Partner closely with software engineering teams to embed:
- Own subsets of the Quality System related to software design controls, including but not limited to:
- Software Design Control processes
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:
- Proficiency in basic scripting, automation, or querying (e.g., Python, SQL, or equivalent)
- Strong problem-solving mindset with the ability to think in systems rather than silos
Nice to have
- 1-3 years of experience in:
- Software Quality
- Regulated software development
- Expected Compensation:
- We also believe in aligning our employees' success with the company's long-term growth.
Skills
- User needs
- Software requirements
- Risk controls
- Design outputs (code, architecture)
- Verification and validation evidence
- Your actual base pay will be determined by your job-related skills, experience, and relevant education or training.
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.
- $71,000 - $119,000 USD
- What We Offer:
Benefits
- Excellent medical, dental, and vision insurance through a PPO plan
- Commuter benefits
- Equity (RSUs) *Temporary Employees & Interns excluded
- Parental leave *Temporary Employees & Interns excluded
- Flexible time off *Temporary Employees & Interns excluded
- Full-time employees are eligible for the following benefits listed below.
Company info
- We are creating devices that enable a bi-directional interface with the brain.
- Join the Quality Systems Team, where our mission is to ensure compliance with applicable regulatory standards by designing scalable, efficient, and automation-driven systems.
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