Senior Systems Engineer — Neurotech Medical Device

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

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,