Engineering Process Optimization Lead
3 days ago
In this critical position, you will be responsible for identifying, procuring, and commissioning key process equipment to meet CGMP standards, ensuring compliance with quality, output, and cost goals.
Key Responsibilities
- Equipment Selection and Commissioning: Identify, order, and commission key process equipment to meet CGMP standards in the Operations Engineering Cycle, aligning with key business objectives.
- Process Development and Optimization: Develop and modify manufacturing documentation and procedures to support commercial products and new product introductions on the production floor (assembly procedures, BOMs, etc.).
- Quality Assurance: Evaluate and ensure new products meet business, quality, output, and cost goals upon introduction to the production floor.
- Process Improvement: Develop and optimize various manufacturing processes to enhance product and process quality and output.
- Vendor Qualification: Perform product/process/vendor qualification activities as necessary.
- Material Discrepancy Review: Support material discrepancy review and disposition activities (MRB) for existing commercial products.
Requirements
- Bachelor's degree in Mechanical Engineering or Biomedical Engineering or related fields.
- Minimum 8 years of demonstrated process development/improvement experience.
- Process development, equipment validation, process characterization, and validation experience.
- Prefer candidates from medical device or regulated industry backgrounds.
- Required: Six Sigma Black Belt certification and demonstrated use of Design for Six Sigma tools.
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