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Hardware Specialist

2 months ago

San Diego, California, United States Indotronix Avani Group Full time
Job Title: Hardware Engineer

Indotronix Avani Group is seeking a skilled Hardware Engineer to join our team.

Job Summary:

We are looking for a highly motivated and experienced Hardware Engineer to play a critical role in shaping our hardware-centric design control elements and deliverables. The ideal candidate will have a strong background in hardware engineering, requirements management, and implementation of test processes.

Key Responsibilities:

  • Define and document hardware-centric design control elements and deliverables
  • Ensure alignment with regulatory requirements such as FDA guidance
  • Remediate design control documentation for accuracy, completeness, and clear upstream and downstream traceability
  • Drive continuous improvement efforts and collaborate across multi-disciplinary teams
  • Provide technical expertise to ensure successful project outcomes

Requirements:

  • Bachelor's degree in Science or Engineering required; postgraduate degree preferred
  • Minimum 8+ years of related work experience in hardware engineering
  • Experience with regulatory standards (e.g., IEC 62304, FDA guidance, IEEE standards) in a regulated industry highly preferred
  • Strong background in hardware engineering, requirements management, and implementation of test processes
  • Experience in hardware product development, including user needs assessment, hardware system analysis and decomposition, architectural design, integration and testing, etc.
  • Extensive experience in the creation and maintenance of design and development documentation
  • Experience in Quality engineering and design control management a plus
  • Experience with ALM/PLM and/or CAD tools a plus

What We Offer:

Indotronix Avani Group offers a dynamic and challenging work environment with opportunities for professional growth and development.

Language: English