Quality Engineer
Cognito TherapeuticsCambridge, Massachusetts, United States
Posted September 26, 2025
Full Time
About the Company
Cognito Therapeutics is a leader in non-invasive neuromodulation aimed at treating neurodegenerative diseases and enhancing cognitive performance. The company has conducted multiple clinical studies showing promise in slowing or stopping cognitive decline and brain volume loss in Alzheimer's disease, with FDA Breakthrough Device Designation. Founded on groundbreaking optogenetics research by MIT professors, Cognito is poised to begin pivotal trials in 2022.
Job Description
Cognito Therapeutics is seeking a Quality Engineer to drive quality engineering methodologies, systems, and practices within their medical device company. The role involves ensuring compliance with regulations, supporting product documentation, and contributing to continuous improvement. They are a fast-growing company dedicated to translating scientific findings into therapeutic approaches for neurodegenerative conditions.
Requirements
- Regulatory experience (FDA Quality System, ISO 13485, IEC 62304, ISO 14971)
- Experience with Design Controls/Product Realization processes
- MDR (Medical Device Manual Required)
- ASQ-certified quality engineer, ASQ-certified quality auditor, and/or Six Sigma/Lean certified
Benefits
- Competitive Salary
- Health Insurance
- Paid Time Off
