Beacon Biosignals
Systems Engineer
Boston, MA · Director
Sponsorship not specifiedDetected 11 days ago
GitProduct ManagementJiraSystems EngineeringAvidFDA RegulatoryMedical DevicesResearchCommunicationCollaborationProblem Solving
About the role
- Our FDA 510(k)-cleared at-home sleep testing devices integrate multi-channel cardiopulmonary and EEG signals into a single streamlined workflow powered by AI-enabled analytics.
- With a dedication to patient experience and scientific rigor, Beacon enables high-quality clinical diagnostics at scale and powers the development of novel neuromedicines.
- Beacon Biosignals is changing the way that patients are treated for any disorder that affects brain physiology.
Responsibilities
- Develop and maintain device development in accordance with Beacon's QMS.
- Elicit, analyze, and document system and sub-system requirements, ensuring coherence and traceability throughout the product lifecycle.
- Implement verification and validation with proper traceability for system, hardware, and software components. Develop and execute test plans, test cases, and procedures to assess system performance, functionality, and reliability.
- Actively contribute to risk management, including hazard analysis (dFMEA and FMEA) and risk mitigation. Identify, assess, and manage risks associated with system development, production, and post-production maintenance.
- Support and write technical and process-related documents.
- Support the transition of the device from development to production, and lead root cause analysis of issues in production at contract manufacturers.
- To accomplish this goal, you will collaborate with other design, research, manufacturing and quality colleagues to develop products from concept to commercialization.
- Additionally, you will document design in accordance with applicable product development processes, quality and regulatory requirements.
Requirements
- Experience with requirements traceability, risk analysis, verification & validation (V&V), and root cause investigations throughout the product development lifecycle.
- Strong written and verbal communication skills, with the ability to communicate complex technical concepts effectively to both technical and non-technical stakeholders.
- Experience supporting products through manufacturing transfer, sustaining engineering, and change management processes.
Nice to have
- Experience with engineering collaboration and development tools like Git and JIRA, as well as platforms like GitHub and OpenBOM.
Benefits
- Beacon Biosignals is on a mission to revolutionize precision medicine for sleep and brain health.
Company info
- We are the leading at-home sleep test and EEG platform supporting clinical sleep testing and development of novel therapeutics for neurological, psychiatric, and sleep disorders.
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This listing is sourced directly from Beacon Biosignals's careers page and normalized into a canonical job model.