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Lead Hardware & Systems Engineer (Biomedical)
NewPosted 4 months ago
Lead Hardware & Systems Engineer (Biomedical)
- Wearable Patch Hardware • Design and engineer a flexible, body-worn medical-grade patch in compliance with applicable biocompatibility and electrical safety standards • Develop the electrode array and stimulation delivery system, optimizing signal parameters for therapeutic efficacy and user comfort • Integrate wireless communication, power management, and charging systems into a discreet wearable form factor • Ensure IPX-rated durability and reliability for daily wearable use • Wireless communication: Bluetooth Low Energy (BLE) stack connecting patch to companion app; reliable pairing, session management, real-time intensity control • IPX4 minimum waterproofing: robust sealing for daily-wear activities
Biosensor Integration
• Integrate a multi-modal physiological sensing layer into the wearable device for continuous health monitoring
• Solve the signal integrity challenges inherent in combining therapeutic stimulation with concurrent sensing on a shared hardware platform
• Develop robust signal processing to produce clinically reliable data from an ambulatory wearable environment
• Ensure sensor data quality meets the standards required for the AI pattern analysis and clinical escalation functions downstream
Firmware and Embedded Software
• Write and own all embedded firmware for the device: power management, therapeutic protocol execution, sensor data acquisition, and wireless communication
• Develop and maintain software lifecycle documentation compliant with IEC 62304 for medical device software
• Over-the-air (OTA) firmware update capability
• Implement safety-critical behaviours appropriate for a Class IIa active medical device worn on skin
Regulatory Technical Documentation
• Build and maintain the technical file for CE Mark (EU MDR 2017/745) and MOHAP UAE regulatory submissions
• Own the risk management file per ISO 14971 throughout the product development lifecycle
• Electromagnetic compatibility testing preparation per IEC 60601-1-2
• Biocompatibility testing protocol and pre-screen per ISO 10993 series
• Electrical safety verification per IEC 60601-1
• Usability engineering file per IEC 62366-1
