Quality Systems Engineer

We are creating devices that enable a bi-directional interface with the brain. Join the Quality Systems Team, where our mission is to ensure compliance with applicable regulatory standards by designing scalable, efficient, and automation-driven systems.

Requirements

• Design and implement scalable software design controls systems aligned with IEC 62304 and FDA design control requirements (21 CFR 820.30)
• Develop and maintain end-to-end traceability frameworks linking user needs, software requirements, risk controls, design outputs, verification and validation evidence
• Integrate software risk management into design controls, ensuring alignment with ISO 14971 principles
• Build change control mechanisms capable of supporting rapid iteration, parallel development, same-day deployment
• Partner closely with software engineering teams to embed compliance with CI/CD pipelines, automated evidence generation, controlled release processes
• Own subsets of the Quality System related to software design controls, including but not limited to software design control processes, software risk management, software change control, software verification & validation traceability

Benefits

• Excellent medical, dental, and vision insurance through a PPO plan
• Paid holidays
• Commuter benefits
• Meals provided
• Equity (RSUs)
• 401(k) plan
• Parental leave
• Flexible time off