About the Role:
We are seeking a highly motivated and detail-oriented Medical Device Hardware Engineer to join our team. This role is critical in the design, development, and testing of hardware systems for innovative medical devices. The ideal candidate will have strong technical expertise, a passion for solving complex engineering challenges, and a commitment to delivering high-quality products that improve patient outcomes.

Key Responsibilities:

Hardware Design and Development

• Design, develop, and optimize hardware components for medical devices, including analog, digital, and mixed-signal circuitry.
• Create schematics, PCB layouts, and design documentation using CAD tools (e.g., Altium, Eagle, or OrCAD).
• Develop embedded systems hardware, including microcontrollers, sensors, and communication interfaces.

Prototyping and Testing

• Build and evaluate hardware prototypes to verify design concepts.
• Conduct hardware testing to ensure compliance with regulatory standards (e.g., IEC 60601, ISO 13485).
• Perform failure analysis and implement design improvements based on testing results.

Collaboration and Integration

• Collaborate with cross-functional teams, including software, mechanical, and quality engineers, to integrate hardware components into complete systems.
• Work closely with suppliers and manufacturing teams to ensure efficient production of hardware components.

Regulatory and Documentation

• Ensure all hardware designs meet medical device regulatory requirements (FDA, CE marking, etc.).
• Maintain detailed design history files, risk assessments, and test reports for regulatory submissions.

Continuous Improvement

• Research and incorporate new technologies, components, and methods to enhance product performance and reliability.
• Provide technical input to improve hardware development processes and workflows.

Qualifications:

Education:

• Bachelor’s or Master’s degree in Electrical Engineering, Biomedical Engineering, or a related field.

Experience:

• 3-5 years of experience in hardware design for medical devices or a regulated industry.
• Familiarity with medical device standards such as IEC 60601 and ISO 14971 is highly desirable.

Technical Skills:

• Expertise in analog and digital circuit design, PCB layout, and embedded systems.
• Proficiency with CAD tools for schematic capture and PCB design (e.g., Altium, Eagle, or OrCAD).
• Strong understanding of power supply design, RF communication, and sensor integration.
• Experience with hardware testing tools such as oscilloscopes, multimeters, and spectrum analyzers.
• Knowledge of signal integrity, EMC/EMI design, and mitigation techniques.