Senior Hardware Engineer

Position OverviewWe are looking for a hands-on, multi-skilled Senior Hardware Engineer to own the end-to-end design, development, and lifecycle management of our handheld point-of-care IVD reader hardware.

In this role, you will lead high-precision mixed-signal PCB design (analog front-ends for micro-current electrochemical sensing and digital interfaces), firmware development on microcontrollers like PIC and Holtek, vendor coordination for components and plastic tooling/enclosures, and technical authoring of the Device Master Record (DMR) / Design History File (DHF) to satisfy ISO 13485 and CDSCO medical device standards.

• Key Responsibilities1. Hardware & PCB DesignSchematics & PCB Layout: Design high-density, multi-layer rigid/flexible PCBs using industry EDA tools (Altium Designer, KiCad, or OrCAD).
• Analog & Mixed-Signal Engineering: Design low-noise, high-sensitivity Analog Front-Ends (AFE) tailored for electrochemical biosensing (potentiostat circuits, picoamp/nanoamp current measurement, signal conditioning, filtering, and ADC conversion).
• Power Management & Battery Systems: Architect ultra-low-power battery management systems (Li-ion/Li-Po charging, fuel gauging, DC-DC buck/boost converters, and sleep-mode optimization) suitable for portable handheld devices.
• Prototyping & Bring-up: Perform board bring-up, signal integrity testing, hardware debugging using oscilloscopes, logic analyzers, and multimeters.
• 2. Embedded Firmware DevelopmentFirmware Coding: Develop, debug, and optimize bare-metal and RTOS-based embedded firmware in Embedded C / C++.
• Microcontroller Expertise: Implement robust firmware targeting Microchip PIC (PIC16/PIC18/PIC24/dsPIC) and Holtek (e.g., HT66F, BH66F, or specialized medical/metering MCUs) series microcontrollers.
• Peripherals & Communication: Implement device drivers for ADC/DAC, PWM, timers, displays (monochrome/color LCD, OLED), storage (EEPROM/Flash), and communication protocols (I2C, SPI, UART, USB, Bluetooth/BLE).
• Algorithm Implementation: Implement signal processing routines, calibration lookup tables, lot-specific curve calculations, and error-handling routines for test-strip insertion and measurement.
• 3. Vendor Management & DFM/DFAComponent Sourcing: Identify, evaluate, and select electronic components, balancing technical parameters, lifecycle availability, second-sourcing, and BOM cost.
• Fabrication & Assembly Management: Coordinate directly with PCB fabricators (bare-board specifications, stackups, surface finishes) and PCBA assembly houses (stencil design, pick-and-place, AOI/X-ray inspection).
• Enclosures & Mechanical Integration: Interface with mechanical designers and tooling/injection molding vendors for custom plastic enclosures, snap-fits, connector alignment, and strip-port ingress protection.
• 4. Medical Device Compliance & Documentation (ISO & CDSCO)Design Controls & DHF: Build and maintain the Design History File (DHF) and Device Master Record (DMR) in compliance with ISO 13485:2016 and CDSCO MDR 2017.
• Standards Compliance: Ensure circuit designs comply with IEC 61010-1 / IEC 61010-2-101 (Safety requirements for electrical IVD equipment) and IEC 61326-2-6 (EMC requirements for IVD medical equipment).
• Firmware Lifecycle Documentation: Generate firmware lifecycle documentation, verification test protocols, and traceability matrices in accordance with IEC 62304 (Medical Device Software Lifecycle).
• Verification & Validation (V&V): Formulate and execute hardware verification protocols, environmental stress testing, drop testing, and electrostatic discharge (ESD) mitigation.
• Required Qualifications & ExperienceEducation:
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• Bachelor’s or Master’s degree in Electronics & Communication Engineering (ECE), Electrical Engineering (EEE), Embedded Systems, or Instrumentation Engineering.
• Experience:
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• 3 to 8 years of core hands-on experience in mixed-signal PCB hardware design and embedded firmware programming.
• Proven experience developing battery-operated handheld consumer electronics or medical/IVD instrumentation.
• Strong hands-on coding background in C/C++ with specific expertise in Microchip PIC and Holtekmicrocontroller architectures.
• Demonstrated experience taking a product from schematic concept through prototype fabrication, tooling/enclosure integration, to volume manufacturing.
• Working knowledge of medical regulatory expectations (ISO 13485, CDSCO, IEC 60601 / IEC 61010, IEC 62304).

Technical Skills & ToolsAreaTools & TechnologiesEDA / CAD ToolsAltium Designer, KiCad, OrCAD / AllegroMicrocontrollersHoltek (BH66F / HT66F series), Microchip PIC (PIC16, PIC18, PIC24, dsPIC)Languages & ToolchainsEmbedded C, C++, MPLAB X, Holtek Hope3000 / HT-IDE3000, GCCProtocols & BussesI2C, SPI, UART/USART, USB, BLE, ModbusHardware DisciplinesLow-noise Analog Front-End (AFE), Transimpedance Amplifiers (TIA), SMPS/LDO design, ESD/EMI protectionQuality & ComplianceISO 13485, CDSCO Medical Device Rules 2017, IEC 62304, IEC 61010-2-101, IEC 61326