ISO 13485 medical device manufacturer with ultrasound transducer focus
Sonele manufactures medical devices in an FDA-registered facility, with deep expertise in ultrasound transducers backed by proprietary hardware. The tech stack—SolidWorks, MATLAB, FPGA design tools (Xilinx, Verilog, SystemVerilog), ANSYS, COMSOL—reflects a hardware-centric engineering culture bridging simulation, PCB/FPGA design, and manufacturing. Active hiring across engineering and manufacturing (10 roles posted in the last 30 days) combined with pain points around design transfer, manufacturability, and cost reduction suggests the company is scaling production of mature designs while building next-generation ultrasound acquisition and beamforming pipelines.
Sonele is a 11–50 person medical device manufacturer based in Markham, Ontario, specializing in ultrasound transducers and electro-mechanical medical devices. The company operates an ISO 13485 and FDA-registered facility and handles product development through commercialization, including supply chain management, manufacturing line setup, assembly, and international distribution. The ultrasound division markets transducers with proprietary performance advantages. Current project activity spans design transfer, pilot production, prototype development, and process optimization—typical of a manufacturer scaling products from engineering into high-volume manufacturing.
SolidWorks for CAD and PDM; MATLAB, ANSYS, COMSOL for simulation; Xilinx, Verilog, SystemVerilog, VHDL for FPGA design; C/C++ and Python for firmware; Altium and Cadence for PCB/schematic design; Oracle and Microsoft Office for business operations.
Headquartered in Markham, Ontario, Canada, and currently hiring in Canada only.
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