Neuralink
Software Design Control Engineer
About this role
Neuralink is seeking a Software Design Control Engineer to enhance software design control systems embedded with regulatory compliance. The role involves optimizing systems for the development of regulated medical devices, with a focus on scalability and efficiency in compliance processes.
What you'll do
- Design and implement software design controls aligned with IEC 62304 and FDA requirements
- Develop end-to-end traceability frameworks linking user needs to verification evidence
- Integrate software risk management into design controls following ISO 14971
- Establish change control mechanisms for rapid software iteration and deployment
- Collaborate with software engineering teams to ensure compliance in CI/CD pipelines
- Manage subsets of the Quality System related to software design controls
What they're looking for
- Bachelor's degree in relevant engineering field
- Experience with structured engineering or compliance systems
- Familiarity with software development lifecycles in regulated environments
- Knowledge of design controls and requirements management
- Proficiency in scripting or automation (e.g., Python, SQL)
- Excellent communication skills
- Strong problem-solving abilities
- Understanding of IEC 62304 and FDA design controls
Benefits
- Competitive salary
- Equity compensation in the form of RSUs
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Neuralink
Neuralink develops brain-computer interface technology and neurosurgical robots to enable direct interaction between the brain and computing systems. The company is hiring engineers across clinical implementation, user interface design, manufacturing, and software development to support its pioneering medical devices and surgical systems.
- Website
- neuralink.com
Likely interview questions
- Can you describe your experience designing or maintaining structured engineering systems in a regulated or safety-critical environment, and what specific standards or frameworks did you work with?
- How have you approached building end-to-end traceability systems linking requirements, risk controls, design outputs, and verification evidence?