Abbott Senior Manufacturing Process Engineer in Menlo Park, 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.
Summary: this position is focused on process validation for on-market products (MitraClip). The ideal candidate comes from a medical device manufacturing or quality engineering background, working in a manufacturing environment.
Degreed engineer (Mechanical or Materials engineer preferred) with 5+ years experience. Medical device manufacturing experience required. Experience with medical device compliance practices, device manufacturing and electro-mechanical equipment is preferred. Knowledge of validations , statistics and good documentation practices is required.
Provide validation strategy, create documents and perform process validations for both equipment and process improvements. Daily activities include understanding the medical device manufacturing process/equipment and proposed changes (both vendor processes and in house processes/ equipment), assessing potential impact to product specifications and create a strategy on how to best test and ultimately validate changes. Some specific job duties include developing master validation plans, support compliance audits, create and implement changes, lead Root Cause Analysis (RCA) and documentation as required to ensure validated state of the product is maintained.
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