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Senior Hardware Engineer

2 months ago

madurai, India Aurolab Full time

Job Title: Medical Device Hardware Engineer

Job Summary: We are seeking a skilled and innovative Medical Device Hardware Engineer to join our team focused on advancing healthcare technology. The ideal candidate will have a strong background in hardware engineering, with specific experience in medical device development. As a Medical Device Hardware Engineer, you will be responsible for designing, testing, and optimizing hardware components and systems for medical devices, ensuring compliance with regulatory standards and industry best practices.

Responsibilities:

  • Collaborate with cross-functional teams to define hardware requirements and specifications for medical devices, considering factors such as performance, reliability, and regulatory compliance.
  • Design and develop hardware architectures, including circuit boards, sensors, microcontrollers, and interfaces, to meet the functional and safety requirements of medical devices.
  • Conduct schematic capture, PCB layout, and prototyping of hardware designs using CAD tools such as Altium Designer, Eagle, or KiCad.
  • Perform design verification and validation activities, including electrical testing, signal analysis, and compliance testing (e.g., EMC/EMI, safety) according to applicable standards (e.g., IEC 60601, ISO 13485).
  • Work closely with software engineers to integrate hardware components with embedded software/firmware, ensuring seamless operation and system functionality.
  • Collaborate with suppliers and manufacturing partners to select components, establish manufacturing processes, and support product assembly and testing.
  • Conduct risk assessments and participate in risk management activities, including hazard analysis and mitigations, as part of the design control process.
  • Document all aspects of hardware design, development, and testing activities in compliance with regulatory requirements and internal quality management systems.
  • Stay informed about emerging technologies and industry trends related to medical device hardware, and propose innovative solutions to enhance product performance and competitiveness.
  • Provide technical support to internal teams, including troubleshooting hardware-related issues, analyzing root causes, and implementing corrective actions as needed.

Qualifications:

  • Bachelor’s, Master’s in Electrical Engineering, Electronics Engineering, or a related field.
  • Proven experience in hardware design and development, preferably in the medical device industry.
  • Proficiency in schematic capture and PCB layout software (e.g., Altium Designer, Eagle, KiCad).
  • Strong understanding of analog and digital circuit design principles, including signal processing, power management, and communication interfaces (e.g., UART, SPI, I2C).
  • Familiarity with regulatory standards and requirements for medical devices, such as IEC 60601, ISO 13485, and FDA 21 CFR Part 820.
  • Experience with design verification and validation testing, including electrical testing, EMC/EMI testing, and safety testing.
  • Knowledge of design for manufacturability (DFM) and design for reliability (DFR) principles, with the ability to optimize hardware designs for production.
  • Excellent problem-solving skills and the ability to work effectively in a multidisciplinary team environment.
  • Strong communication skills, with the ability to convey technical information clearly and concisely.

Preferred Qualifications:

  • Minimum 10 years of Experience with embedded systems development and programming languages (e.g., C, C++, Python) for microcontrollers and DSPs.
  • Familiarity with wireless communication technologies (e.g., Bluetooth, Wi-Fi, cellular) and their integration into medical devices.
  • Knowledge of sensor technologies commonly used in medical devices, such as accelerometers, pressure sensors, and biosensors.
  • Previous experience with electromechanical systems and mechatronics, including motors, actuators, and feedback control systems.