Staff Electrical Engineer (Hybrid - Acton, MA)

Position Overview: 

This is a senior electrical engineering position responsible for the design, development, and manufacturing transfer of low-power, battery-operated medical device electronics, focusing on wearable device wireless connectivity (Bluetooth Low Energy/BLE) and EMI/EMC/ESD robustness.

The role requires a strong understanding of analog and digital circuit design, proven expertise in leading technical projects, and managing multiple tasks concurrently. This individual will collaborate closely with other electrical engineering team members, outside contract design houses, vendors, and the manufacturing, software, mechanical, and quality groups. As a senior technical contributor, this individual collaborates cross-functionally and reports directly to the Sr. Manager of Electrical Engineering. 

Key Responsibilities: 

• Lead the design and development of low-power battery operating devices, including Bluetooth-connected wearable devices or similar wireless-enabled medical technology. 

• Architect, review, and approve Block Diagrams, Schematics, PCB Layout, and Bills of Material (BOM). 

• Define and execute EMI/EMC/ESD requirements and compliance test plans for the product, including defining and reviewing compliance pre-screening and test plans. 

• Design and execute BLE connectivity on-body characterization plan. 

• Lead root cause analysis for design and manufacturing issues at the PCB/PCBA and system level. 

• Ensure design and documentation comply with medical device quality system guidelines, including FDA design control guidelines, ISO 13485, 21 CFR 820, and IEC 62304. 

• Ensure smooth design transfer from R&D to Manufacturing and post-release support. 

• Mentor and manage technical teams. 

Education and Experience: 

Minimum Requirements: 

• Minimum of a Bachelor Degree in Electrical Engineering or similar discipline and minimum of 7 years’ experience in electrical engineering related fields. 

• Proficiency in analog, digital, and mixed-signal circuit design and analysis 

• Strong expertise in all aspects of wireless communications, particularly Bluetooth Low Energy (BLE) connectivity.  

• Solid expertise in all aspects of PCB/PCBA design, schematic review, layout, and BOM management. 

• Strong background in embedded electronics design (ARM processors). 

• Demonstrated expertise in device-level EMI/EMC/ESD design, test, and analysis. 

• Experience working with external compliance labs and managing external service providers. 

• Hands-on experience with lab equipment: oscilloscopes, logic analyzers, signal generators, VNA, spectrum analyzer, etc.  

• Proficiency in