Senior Hardware Engineer

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.