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