Hardware Engineer

Natus•Schaumburg, IL

17h

About The Position

As a Senior Principal Engineer within our R&D department, you will lead the hardware architecture and design of our global medical device portfolio. Collaborating with cross-functional teams, you will oversee hardware system architecture, embedded software/firmware development, schematic and PCB layout, design reviews, and system verification through analysis and testing. Your analytical problem-solving skills will be essential in identifying root causes, evaluating optimal solutions, and recommending comprehensive upgrades to prevent future issues. Thriving in a fast-paced environment, you will ensure projects are completed on time, meet regulatory standards, and align with our commitment to quality and innovation.

Requirements

Bachelor’s or master’s degree in electrical engineering or a related field.
Minimum of 10 years of relevant experience in hardware design and development within heavily regulated environments, preferably in the medical device industry.
Demonstrated leadership in driving new medical device product development projects to completion.
Proficiency in microcontroller unit (MCU) design and board bring-up; experience with the STM32 family is a plus.
Comprehensive knowledge of processor architecture, digital circuit design, and various communication protocols such as I2C, UART, SPI, USB, MIPI, and I2S.
Hands-on experience in electrical safety testing and ensuring compliance with relevant standards.
Expertise in leading hardware or firmware design through system integration, encompassing microcontrollers, analog, digital, and power design.
Thorough understanding of FDA Quality Systems Regulations and EU Medical Device Regulations (MDR).
Familiarity with medical device standards and regulations, including ISO 13485 and IEC 60601.
Excellent communication skills with fluency in English, both written and verbal.
Collaborative attitude with the ability to work effectively in a team environment.
Strong engineering, design, and analytical skills, with a proven track record of problem-solving.
Experience guiding medical devices from concept through commercialization, ensuring adherence to regulatory standards and successful market entry.

Responsibilities

Electrical System Design and Development:
Lead the design and development of electrical circuits, including analog and digital systems, power supplies, signal processing units, and data acquisition modules, ensuring compliance with medical device standards.
Capture and review electrical design requirements and features, ensuring alignment with project objectives and regulatory standards.
Create detailed schematics, select appropriate components, and oversee PCB layout using industry-standard ECAD tools.
Prototyping and Testing:
Develop and test prototypes to validate design concepts, identify potential issues, and ensure functionality aligns with clinical needs.
Conduct comprehensive verification and validation testing, including risk assessments and failure mode effects analysis (FMEA), to ensure product safety and reliability.
Ensure designs comply with Electromagnetic Compatibility (EMC) regulations by conducting necessary testing and implementing mitigation strategies.
Regulatory Compliance and Documentation:
Adhere to relevant regulatory standards (e.g., FDA, ISO 13485, IEC 60601-1) throughout the design and development process, including meticulous documentation and reporting.
Review and approve technical documents related to architecture, design, and coding inspections, participating actively in cross-functional technical reviews.
Process Improvement and Cross-Functional Collaboration:
Suggest and implement improvements to hardware development processes, including Design for Reliability (DFR), Design for Manufacturability (DFM), and Design for Test (DFT).
Lead the analysis of external testing results for EMC, Electrostatic Discharge (ESD), and safety testing, addressing any failures through appropriate testing or design modifications.
Collaborate closely with cross-functional teams, including manufacturing engineers, suppliers, and production teams, to optimize designs for manufacturability and scalability.