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Job Description
Job Description: Develop and implement process improvements in a 24/7 environment, utilizing Lean Six Sigma tools and data to drive continuous improvement. Identify and eliminate machine failures, provide consultative support, and develop safety and quality improvements.
- Design and implement process and equipment improvements with minimal impact to production.
- Provide consultative support to the Manufacturing and Maintenance groups.
- Utilize Lean Six Sigma tools and data to drive continuous improvement.
- Develop and implement Safety and Quality improvements.
- Develop methods to ensure personnel have sufficient knowledge to perform their assigned tasks.
- Prepare design specifications and associated documentation for equipment and system upgrades.
- Fault-finding and troubleshooting of equipment and process issues.
- Installation, commissioning, and validation of automation.
- Implement improvements under change control.
- Develop Functional and Detailed Design Specifications from User Requirement Specifications.
- Familiar with 21 CFR part 820 guidelines.
- Presents technical data to internal/external audit and inspection groups.
- Ensures Health and Safety Regulations and Procedures are adhered to.
Qualifications: Bachelor's Degree in engineering (mechanical/electronic) preferred. 3-5 years in a technical role in a high-volume manufacturing environment. Solidworks experience preferred. Six Sigma experience preferred. Good problem-solving abilities. Medical device and/or pharmaceutical industry experience preferred. Experience working in a validated environment with strong discipline regarding change control is preferred.