Lead Systems Engineer, Neurotech Medical Devices

Cognito Therapeutics, Inc.; Cambridge (MA); Presencial; USD 150 000 - 210 000; Tempo integral

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Systems engineering

Cross-functional leadership

Regulatory compliance

Risk management

Product development lifecycle

Design control

Audits/regulatory submissions

Formação académica

BS in engineering or related technical discipline

Descrição da oferta de emprego

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