About the job
About Neuralink:
At Neuralink, we are at the forefront of developing groundbreaking devices that facilitate a bi-directional interface with the human brain. Our innovative technology aims to restore movement for those who are paralyzed, revive sight for the visually impaired, and transform the way individuals engage with the digital world.
Team Overview:
Become a pivotal member of our Quality Systems Team, dedicated to ensuring compliance with regulatory standards through the design of scalable, efficient, and automation-driven systems. We prioritize integrating compliance into our engineering processes, moving beyond a reactive approach.
Our team consists of seasoned professionals who leverage systems thinking and inventive problem-solving to build a robust compliance framework that fosters rapid development. Our vision is to create internal design and quality systems that not only meet but exceed FDA standards, facilitating swift iteration and deployment of complex, safety-critical software products.
Role Responsibilities:
This job posting is a duplicate for the "Quality Systems Engineer" position. We are testing different titles to attract the most qualified candidates. Please apply to only one of the listings.
As a Design Controls Engineer, you will be primarily responsible for designing, implementing, and continually enhancing software-focused design control systems, embedding regulatory compliance into their architecture.
Your role will involve creating systems that eliminate ambiguity, minimize manual processes, and enable the efficient development of regulated medical device software. These systems will encompass the entire software lifecycle, from requirements definition through verification, validation, risk management, and product release.
You will also focus on optimizing these systems to enhance speed, traceability, and audit readiness, all while accommodating rapid development timelines and frequent design changes. Your duties will include, but are not limited to:
- Designing and implementing scalable software design control systems that comply with IEC 62304 and FDA design control requirements (21 CFR 820.30)
- Developing and maintaining comprehensive traceability frameworks that link:
- User needs
- Software requirements
- Risk controls
- Design outputs (including code and architecture)
- Verification and validation evidence
- Integrating software risk management into design controls, ensuring alignment with ISO 14971 principles
- Establishing change control mechanisms to support ongoing development efforts