About the Role
Beacon Biosignals is seeking a System Engineer specializing in hardware to contribute to the development of new and modified EEG device systems. You will be responsible for system and sub-system requirements, verification, risk management, root cause analysis, and manufacturing validations, working closely with cross-functional teams to ensure product quality and reliability from concept to commercialization.
Responsibilities
- Develop and maintain device development in accordance with Beacon’s QMS.
- Apply Systems Engineering principles and best practices to new product development.
- 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.
- Interface with Product Management, Algorithm Development team, and Platform team to ensure smooth integration of sub-systems of Beacon’s products.
- Support and write technical and process-related documents.
- Support the transition of the device from development to production.
- Lead root cause analysis of issues in production at contract manufacturers.
Requirements
- BS in engineering, or related field.
- 5+ years of professional engineering experience with a BS degree or 3+ years with an MS degree.
- Strong analytical and problem-solving skills, with the ability to analyze complex systems, identify technical risks, and drive system-level improvements.
- Experience leading cross-functional technical efforts across hardware, software, firmware, and operations teams to deliver complex integrated systems.
- Experience defining system architectures and developing detailed technical specifications and documentation for multidisciplinary electromechanical systems, including system requirements, design documents, test plans, and test reports.
- 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 working in fast-paced environments with evolving requirements and the ability to independently drive technical analysis and decision-making.
- Experience supporting products through manufacturing transfer, sustaining engineering, and change management processes.
- Experience with engineering collaboration and development tools like Git and JIRA, as well as platforms like GitHub and OpenBOM.
- Experience developing medical devices or other regulated/safety-critical products.
- Familiarity with medical device design controls, risk management practices, and applicable regulatory standards.
Skills
- Systems Engineering
- Requirements Elicitation
- Requirements Analysis
- Requirements Documentation
- Traceability
- Verification
- Validation
- Test Plan Development
- Test Case Development
- Risk Management
- Hazard Analysis
- dFMEA
- FMEA
- Risk Mitigation
- System Integration
- Technical Documentation
- Process Documentation
- Root Cause Analysis
- Manufacturing Transfer
- Sustaining Engineering
- Change Management
- Git
- JIRA
- GitHub
- OpenBOM
- Medical Device Development
- Regulated Product Development
- Safety-Critical Product Development
- Medical Device Design Controls
- Regulatory Standards
Location
- Boston
Work Type
- Hybrid
- Remote
Experience Level
- 5+ years of professional engineering experience with a BS degree
- 3+ years with an MS degree
Education Level
- BS in engineering, or related field
Salary/Compensations
- $120,000 – $140,000
Benefits
- Equity
- PTO
- Other benefits
About the Company
- Beacon Biosignals is on a mission to revolutionize precision medicine for sleep and brain health.
- 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.
- 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.
- At Beacon, we've found that cultural and scientific impact is driven most by those that lead by example.
- As such, we're always seeking new contributors whose work demonstrates an avid curiosity, a bias towards simplicity, an eye for composability, a self-service mindset, and - most of all - a deep empathy towards colleagues, stakeholders, users, and patients.
- We believe a diverse team builds more robust systems and achieves higher impact.
