Principal Hardware Engineer

FOR MORE THAN 80 YEARS, Natus has been committed to serving the varying needs of clinicians, delivering the highest-quality solutions to raise the standard of care for patients everywhere.

Our comprehensive diagnostic and therapeutic sensory solutions are designed to simplify workflows for sensory specialists, ensuring care teams have the right instrumentation to give patients the right support - and greater peace of mind.

As a Principal Hardware 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.

• 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.

• Education & Experience
• 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.
• Technical Expertise
• 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 STM
  32 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.
• Regulatory and Compliance Knowledge
• Thorough understanding of FDA Quality Systems Regulations and EU Medical…