Cognito Therapeutics, Inc. · 19 hours ago
Product Development Engineer
Cambridge, Massachusetts, United States
Full-time
Onsite
Senior Level
5+ years expCognito Therapeutics, Inc. is a late clinical stage company focused on developing therapeutic approaches for brain health. The Product Development Engineer will drive system level architecture, integration, verification, and lifecycle management for their medical device platform, ensuring alignment with design control expectations and collaborating with various stakeholders.
BiotechnologyHealth DiagnosticsMedical DeviceNeuroscienceTherapeutics
Responsibilities
Participate in early-stage system definition activities, including concept development, feasibility assessments, and trade-off analyses to inform architecture, requirements, and risk strategy
Collaborate with cross-functional teams during project planning and brainstorming to translate high-level product concepts into structured system requirements and development plans
Develop, manage, and maintain system level requirements and traceability from user needs through verification and validation
Develop and maintain system architecture documentation, including functional decomposition and interfaces across hardware, software, and human factors
Support system level risk management activities, including hazard analysis and risk controls, in collaboration with Quality and Regulatory teams
Participate in and support design reviews by ensuring system level considerations are documented and communicated clearly
Draft design verification protocols, including objective, scope, test methods, sample size rationale, acceptance criteria, and traceability to requirements
Execute design verification testing, coordinate test readiness, and document results in compliance with quality system requirements
Review and assess the impact of design issues, nonconformances, and verification failures, including impact to requirements, risk, and verification status
Partner with cross functional teams to support root cause analysis, corrective actions, retest strategy, and documentation updates
Support verification, validation, and regulatory documentation needed for design history files and submissions
Work cross-functionally with Quality, Clinical, and Engineering teams to support quality complaint investigations and CAPA activities
Contribute to root cause analysis, impact assessments, and implementation of system level corrective and preventive actions
Create and maintain SolidWorks CAD models and detailed drawings. Prepare engineering change orders that clearly describe design changes, complete full impact assessments, and release documentation packages in accordance with design controls
Collaborate closely with suppliers and contract manufacturers to transfer design specifications for both prototyping and production
Support supplier technical reviews and engineering change activities by ensuring requirements, drawings, and specifications are clearly communicated and fully aligned
Qualification
Required
Bachelor's degree in Engineering or a related technical field with 5+ years of experience in medical device development, or a Master's degree with 3+ years of relevant experience
Experience developing wearable medical electronic devices or other novel therapeutic systems
Working knowledge of requirements management, risk management, and design controls
Experience drafting and executing verification testing
Demonstrated ability to align cross-functional stakeholders through clear communication in ambiguous and evolving technical environments
Experience with ISO 13485, ISO 14971, IEC 62304
Preferred
Experience with SolidWorks
Experience supporting complaint investigations, CAPA, or regulatory submissions
Experience in an early stage or fast-growing company environment
Company
Cognito Therapeutics, Inc.
Cognito Therapeutics is a pioneer in non-invasive neuromodulation to treat neurodegenerative diseases and improve human cognitive performance.
11-50 employees
Funding
Current Stage
Growth StageTotal Funding
$216.77MKey Investors
FoundersX Ventures
2024-01-29Series B· $35M
2023-03-22Series B· $73M
2022-06-27Series Unknown· $108.77M
Leadership Team
Christian Howell
CEO
Zach Malchano
President
Recent News
Longevity.Technology - Latest News, Opinions, Analysis and Research
2025-12-06
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