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Manufacturing Process Engineer II
2 months ago
As a Manufacturing Process Engineer II, you will tackle intricate challenges and devise innovative solutions. Your role will focus on providing manufacturing technology and effective solutions aimed at bringing new products to market while continuously enhancing production methodologies.
Collaboration is key in this position, as you will work alongside engineering teams throughout the organization, as well as with Production, Quality Control, and Quality Assurance departments. Your engineering expertise and creativity will be essential in addressing issues that arise on the production floor, leading to adaptations and modifications in both production and quality systems.
Being a team player is crucial, as you will actively engage in cross-functional teams that explore, develop, optimize, test, and implement robust, scalable solutions for Guardant Health's Manufacturing Operations. A strong understanding of business and user requirements, along with a focus on improving efficiency, throughput, and quality, will be vital to your success.Key Responsibilities:
1. Enhance production processes by designing fixtures, sourcing off-the-shelf tooling and equipment, and integrating new fixturing on the production line.
2. Assist in investigating non-conformances and ensuring CAPA closure.
3. Conduct thorough root cause analyses and propose validated solutions.
4. Support production efforts by training manufacturing associates and quality control technicians, maintaining product and process documentation, and implementing process enhancements that boost yield, efficiency, and throughput.
6. Develop, refine, and release Standard Operating Procedures (SOPs) or Forms from the Development team into Manufacturing through Change Control.
7. Provide user requirements to project teams to guarantee the manufacturability of processes and methods.
8. Develop, characterize, and optimize processes utilizing statistical techniques and engineering knowledge.
9. Coordinate with suppliers and external resources to formulate and execute process improvement plans.
10. Engage in project planning and scheduling activities.
11. Offer ongoing support, including troubleshooting, process enhancement, and new equipment specifications.
12. Establish Key Performance Indicators (KPIs) and monitor progress.
13. Lead 5S and continuous improvement initiatives.
14. Collaborate with cross-functional teams on label design, Safety Data Sheets, and validation processes.
15. Ensure manufacturing processes remain in a validated state.
