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