Senior Hardware Test Engineer

Beacon Biosignals•Boston, MA

1d•Hybrid

About The Position

Beacon Biosignals is developing at-home EEG and cardiopulmonary monitoring platforms for clinical development and precision diagnostics. The Senior Hardware Test Engineer will contribute to developing and modifying 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, firmware unit and integration testing, system integration, root cause analysis, and documentation that meets quality requirements. The role collaborates with design, research, manufacturing, and quality colleagues across product ideation, development, integration verification, and manufacturing, with a focus on product quality and reliability. Design and production processes must be documented in accordance with applicable product development procedures and quality and regulatory requirements. Beacon supports asynchronous work and has office hubs in Boston, New York, and Paris. This role is required to work from the Boston office approximately three days per week on average, with flexible days and hours.

Requirements

Bachelor of Science degree 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 conducting 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 medical-device design controls and regulations.

Responsibilities

Develop and execute device testing in accordance with Beacon’s Quality Management System (QMS).
Develop and document test plans, protocols, and 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.
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 requirements.
Implement process improvements and test automation to improve product quality and testing efficiency.
Perform hardware characterization and verification tests, firmware unit tests, integration tests, verification tests, 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.