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Beacon Biosignals is transforming precision medicine for the brain through at-home EEG and cardiopulmonary diagnostic platforms. The company serves two markets: clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders, and FDA 510(k)-cleared at-home diagnostics combining EEG and cardiopulmonary signals for reimbursable assessments.
As a Systems Engineer specializing in hardware, you will drive the development of new and modified EEG device systems from concept through commercialization. Reporting to the Director of Device Engineering, you will own system and sub-system requirements, verification, risk management, root cause analysis, manufacturing validation, and integration with Algorithm and Platform teams.
Key responsibilities include: developing and maintaining device development per Beacon's Quality Management System; applying systems engineering principles to new product development; eliciting, analyzing, and documenting system requirements with full traceability; implementing verification and validation with proper test plans and procedures; actively contributing to risk management including hazard analysis (dFMEA, FMEA) and mitigation; interfacing with Product Management and Algorithm teams to ensure smooth sub-system integration; writing technical and process documentation; and supporting manufacturing transition and leading root cause analysis of production issues at contract manufacturers.
You will collaborate across hardware, firmware, software, and product teams to deliver complex integrated systems. The role requires strong analytical and problem-solving skills, experience with requirements traceability and V&V throughout product lifecycle, and the ability to work independently in fast-paced environments with evolving requirements. This is a hybrid role based in Boston, with office hubs also available in Paris, New York, and San Francisco Bay Area.
