Covidien - Santa Clara, CA
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Provide technical support and sustaining engineering directly to the manufacturing floor. Work with R&D teams to provide DFM analysis and transfer manufacturing processes into production per applicable regulations and quality system requirements. Provide strong continuous improvement and leadership competencies to drive quality, delivery, and cost improvement in manufacturing. Establish and review process capabilities, control procedures, and output data. Write manufacturing process instructions, design fixtures, configure equipment, provides operator training, and perform field failure analysis.
- Provide engineering support to the manufacturing floor and resolve issues impacting production fulfillment (e.g. troubleshoot existing manufacturing processes, fixtures, tooling or equipment).- Provide primary DFM analysis and guidance to R&D teams.- Champion's continuous improvement projects to enhance yield, consistency, performance, capacity, etc. of equipment and processes.- Define, write, and update process limits, process instructions, BOMs, and LHRs/Work Orders.- Design, build or procure improved fixtures, tooling or equipment to increase quality, reliability, capacity, and yield.- Work with production team to ensure controlled environment room is well maintained, safe, and provides a suitable work environment for assembly operations. - Provide floor layouts for areas associated with manufacturing operations.- Work with R&D teams to transfer new products into commercial manufacturing.- Write test protocols, perform teststo fully characterize new equipment or processes utilizing DOE methodology or other statistically sound methods, then write completion reports.- Perform process capability assessments and establish methods to control process output.- Create process validation protocols, conduct process optimization studies, conduct process verifications and validations, and generate verification and validation reports.- Write and perform IQ's, OQ's and PQ's when introducing new or changing existing manufacturing equipment.- Provide engineering support to outside suppliers, ensuring quality and production targets are met.- Train, develop, and/or provide work direction to operators and technicians.