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Hardware Engineer

2 months ago

san diego, United States Indotronix Avani Group Full time

Role: Hardware Engineer

Location: Remote

Duration: 12 Months


The pay rate is applicable only under W2 guidelines, and we do not offer sponsorships or transfers.



The engineer will play a critical role in shaping the process for defining and documenting hardware-centric design control elements and deliverables, ensuring alignment with regulatory requirements such as FDA guidance, and meeting both user and business needs. They will also be remediating the design control documentation for accuracy, completeness, and clear upstream and downstream traceability from hardware-centric design control elements. The ideal candidate will drive continuous improvement efforts, collaborate across multi-disciplinary teams, and provide technical expertise to ensure successful project outcomes.



Minimum Qualifications

Bachelor’s degree in Science or Engineering is required; a postgraduate degree is preferred.


Experience

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 is 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 is a plus

Experience with ALM/PLM and/or CAD tools is a plus