Hardware Engineer

Indotronix Avani Group - San Diego, CA

Full-time

Remote - San Diego, CA

About the position

The Hardware Engineer will be responsible for defining and documenting hardware-centric design control elements and deliverables, ensuring compliance with regulatory requirements such as FDA guidance. This role involves remediating design control documentation for accuracy and traceability, driving continuous improvement efforts, and collaborating with multi-disciplinary teams to achieve successful project outcomes.

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 and completeness.
• Establish clear upstream and downstream traceability from design control elements.
• Drive continuous improvement efforts in hardware engineering processes.
• Collaborate across multi-disciplinary teams to ensure project success.
• Provide technical expertise to support project outcomes.

Requirements

• Bachelor's degree in Science or Engineering; postgraduate degree preferred.
• Minimum of 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.
• Strong background in hardware engineering and requirements management.
• Experience in hardware product development, including user needs assessment and system analysis.
• Extensive experience in the creation and maintenance of design and development documentation.
• Experience in Quality engineering and design control management is a plus.
• Experience with ALM/PLM and/or CAD tools is a plus.