About the job
About Neuralink:
At Neuralink, we are pioneering groundbreaking devices that facilitate a bi-directional interface with the human brain. Our innovative solutions aim to restore movement to those who are paralyzed, bring sight back to the visually impaired, and transform how individuals engage with their digital environments.
Team Description:
Join our dedicated Quality Systems Team, where we strive to uphold compliance with regulatory standards through the design of scalable, efficient, and automated systems. Our approach integrates compliance seamlessly into engineering workflows, positioning it as a proactive rather than reactive function.
Our team comprises seasoned professionals who employ systems thinking and creative problem-solving to construct a robust compliance framework that supports rapid development cycles. We aim to establish internal design and quality systems that surpass FDA expectations while enabling quick iterations and deployment of complex, safety-critical software products.
Job Description and Responsibilities:
As a Quality Systems Engineer specializing in Design Controls, your primary role will involve designing, implementing, and continuously enhancing software-focused design control systems with regulatory compliance embedded in their architecture.
You will create systems that eliminate ambiguity, minimize manual labor, and facilitate swift, reliable development of regulated medical device software throughout the full software lifecycle, from requirements definition to verification, validation, risk management, and release.
Your continuous optimization of these systems will enhance speed, traceability, and audit readiness, all while supporting aggressive development timelines and frequent design modifications. Your responsibilities will encompass:
- Designing and implementing scalable software design control systems that align with IEC 62304 and FDA design control requirements (21 CFR 820.30).
- Developing and maintaining comprehensive traceability frameworks linking user needs, software requirements, risk controls, design outputs (code, architecture), and verification and validation evidence.
- Integrating software risk management into design controls, ensuring adherence to ISO 14971 principles.
- Establishing change control mechanisms to support rapid iteration, parallel development, and same-day deployment.
- Collaborating closely with software engineering teams to embed compliance into the development process.
