Quality Systems Engineer

About this role

Neuralink is seeking a Quality Systems Engineer to enhance software design control systems, ensuring regulatory compliance and streamlined processes. The role involves optimizing design controls to support rapid development in alignment with FDA standards while facilitating effective communication within engineering teams.

What you'll do

• Design and implement scalable software design control systems.
• Develop end-to-end traceability frameworks linking user needs to verification evidence.
• Integrate software risk management into design controls.
• Establish change control mechanisms for agile development.
• Collaborate with software engineering to embed compliance.
• Manage subsets of the Quality System related to software design and risk management.

What they're looking for

• Bachelor's degree in Electrical Engineering or Computer Science
• Experience with structured engineering compliance systems
• Familiarity with regulated software development lifecycles
• Knowledge of Design Controls and software requirements management
• Proficiency in scripting and automation tools (e.g., Python, SQL)
• Strong problem-solving and communication skills
• Systems thinking mindset
• Familiarity with IEC 62304 and ISO 14971 principles

Benefits

• Base salary range of $71,000 to $119,000
• Equity compensation in the form of RSUs
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