Hardware Test Engineer

Beacon Biosignals•Boston, MA

8d•Hybrid

About The Position

Beacon Biosignals is seeking a hardware test engineer specializing in hardware and firmware to support development of new and modified EEG and Home Sleep Test systems that meet application, business, customer, and regulatory requirements. The role is part of the Device Team, reports to the VP of Device Systems, and works closely with hardware, firmware, system, and software engineers. The engineer is responsible for hardware characterization and verification testing, firmware unit and integration testing, system integration, root cause analysis, and quality documentation. The role contributes to product ideation, development, integration verification, manufacturing, and commercialization, while documenting design and production processes in accordance with applicable development procedures and quality and regulatory requirements. The position requires working from the Boston office on average approximately three days per week, with flexible days and hours. Beacon also offers asynchronous work practices and office hubs in Boston, New York, and Paris. Success in the role includes developing and executing device tests in accordance with Beacon’s QMS; preparing test plans, protocols, and scripts for embedded systems; maintaining test procedures, fixtures, and equipment; conducting functional, integration, system, and regression testing; troubleshooting issues with hardware and firmware engineers; ensuring products meet relevant industry, safety, and regulatory requirements; and improving processes and test automation.

Requirements

Bachelor of Science in engineering or a related field.
At least 5 years of professional engineering experience with a BS degree, or at least 3 years with an MS 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 of hardware and firmware issues in electromechanical systems.
Experience with tools such as Git and JIRA and platforms such as GitHub.

Nice To Haves

Knowledge of design controls and regulations for medical devices.

Responsibilities

Develop and execute device testing in accordance with Beacon’s QMS.
Develop and document test plans, test protocols, and test scripts for embedded 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.
Work with hardware and firmware engineers to troubleshoot and resolve product issues.
Ensure products meet industry standards, safety requirements, and regulatory requirements, including FDA, CE, and 60601.
Implement process improvements and test automation to enhance product quality and testing efficiency.
Perform hardware characterization and verification testing, firmware unit and integration testing, system integration, and root cause analysis.
Collaborate with design, research, manufacturing, and quality colleagues on product development from concept through commercialization.
Document design and production processes in accordance with applicable product development procedures and quality and regulatory requirements.