Senior Systems Engineer

This is a rare opportunity to join a team that is bringing an entirely new category of brain health to the world. At Cognito, we are developing therapies designed to promote dignity, clarity, and coherence in the lives they touch.

Cognito is a neurotechnology company developing a new therapeutic approach to cognitive and neurological health, designed to work with the brain's own activity and biology. Born from pioneering neuroscience research at MIT, Cognito brings together neuroscience, engineering, medicine and technology to translate breakthroughs in brain science into practical therapies designed for everyday life.

Our first therapeutic application, Spectris AD, is an investigational, prescription, at-home therapy for Alzheimer's disease. With our pivotal HOPE study now complete, Cognito is entering an important new phase as we advance Spectris AD toward regulatory review, prepare for potential commercialization and continue exploring the broader potential of our science across neurological health.

We are building an interdisciplinary team united by a shared purpose: protecting and progressing the human ability to think, learn and remember. For innovators who want to work at the intersection of breakthrough science, technology and human health, Cognito offers the chance to help shape what comes next.

About the Job

Cognito Therapeutics is seeking a Senior Systems Engineer to lead systems engineering across the Spectris AD product development lifecycle, from requirements definition through commercialization and post-market support. Reporting to the Senior Vice President of Software Engineering, the Senior Systems Engineer is a cross-functional engineering leader responsible for aligning patient and clinician workflows, product functionality, quality, reliability, serviceability, manufacturability, regulatory compliance, and cost objectives across the therapy delivery modality (headset), the companion app, and the supporting software systems that together deliver Spectris AD.

Core responsibilities include requirements definition and flow-down, system architecture and design, integration, modeling, risk management, design verification and validation, reliability assessment, manufacturing support, and resolution of field issues. The Senior Systems Engineer applies systems engineering principles to translate clinical, patient, and caregiver needs into product solutions through design trade-off analyses, integration, and verification.

The position shapes engineering approaches, projects, and programs across Cognito, driving improvements in product quality, team effectiveness, and operational efficiency. The role calls for deep technical expertise, sound judgment, the ability to coach and influence cross-functional colleagues, and substantial input into priorities, processes, and technical decisions at a company preparing for FDA authorization and commercial launch.

Responsibilities

• Leads systems engineering activities for Spectris AD across the medical device development lifecycle, from concept through commercialization and post-market support.
• Owns the definition, development, and delivery of product features and clinical applications, including requirements management, architecture development, design analysis, integration, verification, validation, and risk management.
• Drives technical risk identification and retirement while ensuring compliance with applicable quality, regulatory, cybersecurity, and safety requirements.
• Leads cross-functional development teams spanning engineering, clinical, quality, regulatory, product management, manufacturing, service, and commercial organizations.
• Ensures requirements flow-down and traceability from patient, caregiver, and clinician needs through system, subsystem, and component level specifications.
• Conducts system design trade-off analyses and makes evidence-based decisions that balance performance, reliability, manufacturability, serviceability, scalability, and cost objectives.
• Leads design control activities including failure modes and effects analysis (FMEA), hazard analysis, design verification and validation planning, reliability testing, defect prevention, and corrective and preventive actions (CAPAs).
• Serves as the primary systems engineering representative for internal and external audits, regulatory submissions including the De Novo submission, design reviews, and compliance activities.
• Provides technical leadership and mentoring to engineering teams, shaping program priorities,…