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:

1. Collaborate with cross-functional teams to define hardware requirements and specifications for medical devices, considering factors such as performance, reliability, and regulatory compliance.
2. Design and develop hardware architectures, including circuit boards, sensors, microcontrollers, and interfaces, to meet the functional and safety requirements of medical devices.
3. Conduct schematic capture, PCB layout, and prototyping of hardware designs using CAD tools such as Altium Designer, Eagle, or KiCad.
4. 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).
5. Work closely with software engineers to integrate hardware components with embedded software/firmware, ensuring seamless operation and system functionality.
6. Collaborate with suppliers and manufacturing partners to select components, establish manufacturing processes, and support product assembly and testing.
7. Conduct risk assessments and participate in risk management activities, including hazard analysis and mitigations, as part of the design control process.
8. Document all aspects of hardware design, development, and testing activities in compliance with regulatory requirements and internal quality management systems.
9. Stay informed about emerging technologies and industry trends related to medical device hardware, and propose innovative solutions to enhance product performance and competitiveness.
10. Provide technical support to internal teams, including troubleshooting hardware-related issues, analyzing root causes, and implementing corrective actions as needed.

Qualifications:

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

Preferred Qualifications:

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