Abbott Reliability Engineer - CAPA Investigation in Alameda, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Conduct investigations into field quality issues on ADC On Market Products. Support R&D and Operations in resolving product technical issue to ultimately improve product reliability and manufacturing yield. Develop and implement continuous improvement programs for on market products by giving input into current meter development based on what has been learned from investigations. Identify, collect, analyze, and manage various types of data to minimize failures and improve performance, using failure analysis and other types of root cause analysis in support of reliability for On Market Products. Originate and develop analytical methods for determining reliability of components, equipment, and processes. Prepare diagrams, charts, drawings, calculations, and reports for defining product reliability and investigation results; to make recommendations for improvements.
Collect and examine basic reliability and investigation data from engineering studies or database, and correlate the data for analysis using established engineering techniques, principles, and/or procedures.
Perform engineering analysis on failure modes.
Initiate elemental engineering studies into equipment/process failures and present details of the analysis to more experienced engineers for approval/feedback for gaining in-depth experience and improving judgment for advancing to higher level jobs.
Work with a cross functional team to develop Corrective and/or Preventive Actions resulting from investigations.
Engage in effective written and verbal communications within the area and cross functionally.
Support a work environment that ensures team effectiveness.
Four-year degree or equivalent experience in a technical (e.g. electrical/mechanical/software) or scientific (e.g. statistics/math) discipline. Equivalent experiences is defined as five years in a role responsible for product engineering, ideally in a medical device industry. Mechanically adept, technically literate, computer literate. Knowledge of FDA Quality System Regulations (QSR) and/or ISO13485 desired, as work product is governed by these regulations and standards; however, this knowledge can be learned on the job. Computer proficiency, preferably with knowledge of software packages such as Word, Excel, and Access, to analyze data and produce reports desired. Tool proficiency, including multi-meters, environmental chambers, calipers, electronic microscopes, etc. Experience with diagnostic or medical device products preferred.
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