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Beacon BiosignalsBeacon BiosignalsBoston, MA

Systems Engineer

Develops and integrates hardware-focused EEG and cardiopulmonary device systems from concept through manufacturing, with responsibility for requirements, verification and validation, risk management, and root cause analysis. Requires an engineering degree and at least five years of professional engineering experience, or three years with a master’s degree.

120k – 140k/yr
Hybrid5+ YOEHardware Engineering

About the role

Responsibilities

  • Develop and maintain device development in accordance with Beacon’s quality management system (QMS).
  • Apply systems engineering principles and best practices to new product development.
  • Elicit, analyze, and document system and subsystem requirements, ensuring coherence and traceability throughout the product lifecycle.
  • Implement verification and validation with traceability for system, hardware, and software components.
  • Develop and execute test plans, test cases, and procedures to assess system performance, functionality, and reliability.
  • Contribute to risk management, including hazard analysis, dFMEA, and FMEA, and identify and mitigate risks associated with system development, production, and post-production maintenance.
  • Interface with Product Management, Algorithm Development, and Platform teams to integrate product subsystems.
  • Write technical and process-related documentation.
  • Support device transition from development to production.
  • Lead root cause analysis of production issues at contract manufacturers.
  • Collaborate with design, research, manufacturing, and quality teams across product ideation, development, integration verification, validation, and manufacturing.
  • Document designs in accordance with product development processes and quality and regulatory requirements.

Requirements

  • Bachelor’s degree in engineering or a related field.
  • 5+ years of professional engineering experience with a bachelor’s degree, or 3+ years with a master’s degree.
  • Strong analytical and problem-solving skills, including 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.
  • Experience defining system architectures and developing technical specifications and documentation for multidisciplinary electromechanical systems.
  • Experience with system requirements, design documents, test plans, test reports, requirements traceability, risk analysis, verification and validation, and root cause investigations.
  • Strong written and verbal communication skills.
  • Ability to work independently and make technical decisions in fast-paced, changing environments.
  • Experience supporting products through manufacturing transfer, sustaining engineering, and change management.

Nice-to-haves

  • Experience with Git, JIRA, GitHub, or OpenBOM.
  • Experience developing medical devices or other regulated or safety-critical products.
  • Familiarity with medical device design controls, risk management practices, and applicable regulatory standards.

Compensation and Benefits

  • Salary range: $120,000–$140,000.
  • Compensation includes base salary, equity, paid time off, and other benefits.

Skills

Systems Engineeringelectromechanical systemsrequirements traceabilityverification and validationRisk ManagementfmeaRoot Cause Analysismanufacturing transferGitJiraGitHubopenbommedical devicesquality management systemsregulatory standards

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