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Beacon BiosignalsBeacon BiosignalsBoston, MA

Test Engineer, Medical Devices

Tests and verifies embedded hardware and firmware for EEG and home sleep-test medical devices, developing protocols, fixtures, automation, and documentation while supporting troubleshooting and regulatory compliance. Requires an engineering degree and 5+ years of experience with a bachelor’s degree, or 3+ years with a master’s degree.

120k – 140k/yr
Hybrid5+ YOEQA Engineering

About the role

Responsibilities

  • Develop and execute device testing in accordance with Beacon’s quality management system (QMS).
  • Develop and document test plans, test protocols, and test scripts for embedded systems, including hardware, firmware, and software, based on design specifications and requirements.
  • Develop and maintain test procedures, fixtures, and equipment.
  • Conduct functional, integration, system, and regression testing on hardware and firmware.
  • Perform hardware characterization and verification tests, firmware unit tests, integration tests, system integration, root cause analysis, and quality documentation.
  • Collaborate with hardware, firmware, system, software, design, research, manufacturing, and quality engineers from concept through commercialization.
  • Troubleshoot and resolve product issues with hardware and firmware engineers.
  • Ensure products meet industry standards, safety, and regulatory requirements, including FDA, CE, and IEC 60601.
  • Implement process improvements and test automation to improve product quality and testing efficiency.
  • Document design and production processes according to product development procedures 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 or above.
  • Experience writing detailed technical specifications and documentation, including requirements, test plans, protocols, and reports.
  • Ability to read and follow electrical schematics.
  • Experience with embedded software running on a real-time operating system (RTOS).
  • Experience with scripting languages such as Python.
  • Experience troubleshooting, debugging, and performing root cause analysis on hardware and firmware issues in electromechanical systems.
  • Experience with Git, Jira, and GitHub.

Nice-to-haves

  • Knowledge of medical-device design controls and regulations.

Compensation and Benefits

  • Salary range: $120,000–$140,000.
  • Total compensation includes equity, paid time off, and other benefits.

Skills

PythonGitJiraGitHubrtoselectrical schematicsfirmware testinghardware testingtest automationRoot Cause AnalysisEmbedded Systemsfda regulationsiec 60601medical device design controls