Published Date: December 20, 2025
TMP Worldwide India Private Limited for ERS US, Irvine, CA
Job Description:
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.
