Systems Engineer at Beacon Biosignals | United States | Rezi

Systems Engineer at Beacon Biosignals

Systems Engineer

Beacon Biosignals · United States

1 weeks ago

Systems Engineer

Beacon Biosignals · United States

8 days ago
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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.