Senior Systems Engineer

Cognito Therapeutics, Inc.; Cambridge (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

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 VP of Software Engineering, you will align patient and clinician workflows, product functionality, quality, reliability, serviceability, manufacturability, regulatory compliance, and cost objectives across the headset, companion app, and supporting

Qualifications

• Minimum of 8 years engineering experience in product development.
• Minimum of 6 years in systems engineering, product development, and design control in a regulated setting.
• Experience with FDA design controls (21 CFR 820), ISO 13485, ISO 14971, IEC 60601-1, IEC 62304, IEC 62366-1.
• Experience leading cross-functional teams and complex programs.
• Knowledge of system architecture and software-hardware interactions.
• FMEA, reliability engineering, and QMS practices.

Responsibilities

• Lead systems engineering across the Spectris AD lifecycle, from concept to post-market support.
• Define, develop, and deliver product features including requirements, architecture, and risk management.
• Drive technical risk retirement while ensuring quality, regulatory, cybersecurity, and safety compliance.
• Lead cross-functional teams including engineering, clinical, regulatory, quality, and manufacturing.
• Ensure traceability from patient needs to system and component specifications.
• Conduct system trade-off analyses balancing performance, reliability, manufacturability and cost.
• Lead design control activities including FMEA, hazard analysis, V&V planning, and CAPAs.
• Represent systems engineering in audits, regulatory submissions, design reviews, and compliance.
• Provide technical leadership and mentoring across product generations.

Skills

Systems engineering

Cross-functional leadership

Regulatory compliance

Risk management

Product development lifecycle

Design control

Audits/regulatory submissions

Education

BS in engineering or related technical discipline

Job description

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, development strategies, and execution plans across multiple product generations.
• Collaborates with internal teams and external development and manufacturing partners to resolve complex technical challenges, manage dependencies across subsystems, and ensure the components of Spectris AD integrate into a single coherent service.
• Supports manufacturing, field service, and patient support escalations, driving root cause analysis and continuous product improvement.

Reporting Relationship

This role reports directly to the Senior Vice President of Software Engineering, with close day-to-day collaboration with Cognito’s engineering, quality, regulatory, clinical, and manufacturing teams on design control, tooling, and process standards.

Qualifications

• BS in engineering, computer science, biomedical engineering, electrical engineering, mechanical engineering, or a related technical discipline; an advanced degree is a plus but not required.
• Minimum of 8 years of engineering experience in product development.
• Minimum of 6 years of experience with systems engineering, product development, and design control processes within medical device, healthcare technology, or another highly regulated industry.
• Demonstrated command of the product development lifecycle, requirements management, risk management, design verification and validation, and regulatory compliance.
• Experience leading cross-functional product development teams and complex technical programs.
• Knowledge of system architecture, subsystem integration, and the interaction of software and hardware.
• Working knowledge of FDA design controls (21 CFR 820), ISO 13485, ISO 14971, IEC 60601-1, IEC 62304, and IEC 62366-1.
• Expertise in failure modes and effects analysis (FMEA), reliability engineering, and Quality Management System (QMS) practices.
• Experience supporting regulatory submissions, audits, or inspections is a plus but not required.
• Experience with neurotechnology, wearable or home use medical devices, or connected device and companion application architectures is a plus but not required.
• Experience leading new product introductions and multi-generational product development programs is a plus but not required.
• Strong analytical, problem solving, communication, and stakeholder management skills.
• Proven ability to lead and influence technical strategy, mentor engineers, and drive execution across teams without formal authority.
• Comfort operating in a fast-paced, dynamic environment with evolving priorities.

Cognito Therapeutics is proud to be an Equal Opportunity Employer.