Product Development Engineer

Cognito Therapeutics•Cambridge, MA

About The Position

Cognito is seeking a Product Development Engineer to drive system level architecture, integration, verification, and lifecycle management for our medical device platform. This role translates user needs and clinical use cases into clear, testable system requirements and ensures end-to-end traceability across requirements, risks, design outputs, and verification evidence in alignment with design control expectations. The Product Development Engineer partners closely with engineering, quality, clinical, and regulatory stakeholders to support change management, system performance, and readiness for design reviews, audits, and regulatory submissions. The Product Development Engineer defines verification strategy and coverage, authors and reviews verification plans and protocols, develops test methods and acceptance criteria, and ensures test setups, fixtures, and tools enable repeatable execution. They coordinate and perform system level integration and verification testing, document results and objective evidence, investigate anomalies, and drive structured root cause analysis and resolution with cross functional teams in a fast-paced startup environment.

Requirements

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.

Nice To Haves

Experience with SolidWorks preferred.
Experience supporting complaint investigations, CAPA, or regulatory submissions.
Experience in an early stage or fast-growing company environment.

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.