Designation Senior Hardware Designer

Key Responsibilities

• Hardware and embedded System design & sustainability
• Responsible for hardware design, engineering changes ,design updates, obsolescence management, hardware validation and ensuring full compliance with IEC 60601-1 standards related to electrical safety and EMI/EMC along with the test coverage, traceability, and maintaining regulatory readiness in alignment with ISO 13485,ISO 14971 requirements.
• Responsible for designing hardware circuits involving analog op-amp configurations, including DC-DC converters, LDO regulators, sensor interface modules, microcontrollers, and various communication interfaces.
• Design and develop detailed test cases, drafting protocols and procedures based on system-level hardware requirements and use cases, performing system integration, verification, and validation testing, including dry runs, pre-verification, and formal testing to ensure design inputs and user needs are met.
• Expertise in design schematics and BOM as per requirements using OrCAD or Altium Tool.
• Responsible for hardware defect management,Troubleshoot and resolved hardware issues while providing technical support during prototype builds, ICT/FCT execution, and board bring-up activities in PCBA manufacturing.
• Responsible for pre-compliance, compliance testing activity as per IEC-60601-1 and its collateral standards with associated documentation and certifications with test report release.
• Responsible for standards assessment, gap analysis, and maintenance of requirement traceability matrices in alignment with applicable IEC and ISO standards.
• Coordinated and executed EMI, EMC, ESD, and Reliability testing both in-house and at certified external laboratories, identified and debugged issues and implemented design modifications to ensure compliance with product standard requirements
• Collaborate with software engineers, mechanical engineers, and other team members to integrate hardware with software and mechanical designs.
• Conduct tests, board bring up, Validation, simulations to ensure the functionality and reliability of hardware systems using test equipment like Power analyzers, High speed Oscilloscopes, Spectrum & logic analyzers, Safety tester, RF Shield rooms/chambers.
• Analyzing and addressing field issues, component obsolescence and EOL, Alternate parts approvals BOM optimizations.
• Responsible for maintaining project lifecycle documentation, including DCP/DCN, ECR/ECO processes, using Agile PLM tools.
• Supporting DFMEA/FMEA risk management file report preparing and reviewing activities.

Skills

Hardware Design:

Electronic Product Hardware Integration:

Characterization and Data Analysis:

Debugging and Repair Expertise:

Cad Design and Simulation:

Failure Modes and Effects Analysis (FMEA):

Standards Compliance Testing:

Familiarity with IEC Basic Safety and EMI/EMC Standards:

Hardware Validation: