Senior Systems Engineer

Cognito Therapeutics; Cambridge (MA); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Unlimited PTO

Wellness perks

Virtual medical support

Health insurance

Dental insurance

Vision insurance

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. You will align patient workflows, product functionality, quality, reliability, and regulatory compliance across the headset, companion app, and supporting software systems.

Responsibilities include defining requirements, architecture, integration, risk management,

Qualifications

• BS in engineering, computer science, biomedical engineering, electrical engineering, mechanical engineering, or related technical discipline.
• Minimum of 8 years of engineering experience in product development.
• Minimum of 6 years of experience with systems engineering, product development, and design control in medical device or regulated industry.
• Experience leading cross-functional product development teams and complex programs.
• Knowledge of system architecture and software-hardware interactions.
• Working knowledge of FDA design controls and standards.
• Experience with regulatory submissions, audits, or inspections is a plus.

Responsibilities

• Leads systems engineering across the product lifecycle from concept to post‑market support.
• Owns requirements management, architecture development, design analysis, integration, verification, validation, and risk management.
• Drives technical risk identification and mitigation while ensuring quality, regulatory, cybersecurity, and safety requirements.
• Leads cross‑functional teams spanning engineering, clinical, quality, regulatory, product management, manufacturing, service, and commercial.
• Ensures traceability from patient and clinician needs through system and component specs.
• Performs design trade‑offs balancing performance, reliability, manufacturability, serviceability and cost.
• Leads design control activities including FMEA, hazard analysis, V&V planning, reliability testing, CAPAs.
• Represents systems engineering in audits and regulatory submissions including De Novo.
• Provides technical leadership and mentoring across multiple product generations.
• Collaborates with internal teams and external partners to integrate components into a cohesive service.
• Supports manufacturing, field service, and patient support escalations with root cause analysis.

Skills

Systems engineering

Regulatory compliance

Cross-functional leadership

Design control processes

Risk management

FMEA

QMS practices

Education

BS in engineering or related technical discipline

Tools

FDA design controls (21 CFR 820)

ISO 13485 / ISO 14971

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.

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.

Competitive Benefits

Taking care of our own is one of our highest priorities. That's why we offer benefits including unlimited PTO, wellness perks, virtual medical support, and health, dental, and vision insurance.

Physical Requirements & Work Environment

• This role is primarily performed in an office or home‑office setting. Essential physical requirements include the ability to work at a computer for extended periods, communicating effectively in written and verbal formats, and participate in video and in‑person meetings.
• Occasional travel to partner sites may be required. For remote roles, occasional travel to Cognito's Cambridge, MA office may also be required.

Cognito Therapeutics is committed to providing reasonable accommodation for qualified individuals with disabilities throughout the application and hiring process. If you require accommodation, please contact us at [e-mail].

Cognito Therapeutics is an Equal Opportunity Employer. We are committed to building a diverse and inclusive workplace and make employment decisions based on qualifications, merit, business needs, and job requirements. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable federal, state, or local law.

All applicants must be legally authorized to work in the United States.