Hardware Engineer

HCLTech is looking for a Senior Systems/Hardware Engineer with over 7 years of experience in medical device new product development (NPD). The ideal candidate will possess strong skills in analog and digital design, system integration, and a thorough understanding of IEC 60601 and FDA regulations. This full-time position is based in Irvine, CA and requires onsite work.

Responsibilities:

• Lead end-to-end NPD processes including system architecture, design, rapid prototyping, integration, testing, verification and validation (V&V), and design transfer.
• Design analog and digital boards involving microprocessors, microcontrollers, memory, sensors, and amplifiers.
• Utilize interface protocols such as I2C, UART, SPI, USB, and PCI in product development.
• Engage in high-density cable design, harnessing, and cabling.
• Employ ECAD tools like OrCAD or Allegro for schematic generation and PCB layout, including DFx and Gerber release.
• Manage component engineering and BOM generation for prototypes, pilot, and production phases.
• Ensure compliance with IEC 60601, FDA submissions, and medical regulatory standards.
• Conduct VAVE analysis and vendor discussions for qualifications.
• Utilize test equipment such as oscilloscopes, multimeters, flow meters, and signal analyzers for testing and troubleshooting.
• Draft test protocols and generate comprehensive reports on findings.
• Perform bench testing, system characterization, troubleshooting, and verification.

Qualifications:

• Bachelor’s degree in Electrical Engineering or equivalent.
• 7+ years of relevant work experience in medical device NPD.

Skills:

• Strong analog and digital design expertise.
• Proficient in system integration and testing.
• Knowledge of medical capital systems product life cycle and disposables.
• Familiarity with interface protocols (I2C, UART, SPI, USB, PCI).
• Experience with ECAD tools (OrCAD, Allegro) and PCB layout.
• Understanding of IEC 60601 and FDA regulatory standards.
• Excellent communication and cross-functional collaboration skills.