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