Lead product sustaining and life-cycle engineering effort for current production products.
Design new and re-design existing 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.
Requirements
Minimum of a Bachelor Degree in Electrical Engineering or similar discipline
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 Microsoft Office (Word, Excel, PowerPoint)
Experience with engineering tools: Cadence OrCAD, PCB Editor, MATLAB, Minitab
Strong verbal and written communication skills for reporting status to senior management.