Company Type
Medical Manufacturer
Location
Maple Grove, Minnesota OR Harrisburg, Pennsylvania
Job Description
• Responsible for assisting in the construction, modifications, conditioning and pre-production phases of new molds.
• Coordinate the development of new molds from inception through final conditioning to their release to manufacturing for production.
• Participate in Tool Design Reviews and recommend improvements to optimize molding, setup, and overall manufacturing
• Ensures consistent and repeatable processes are developed
• Identify key products characteristics to be monitored at Product validation and during production phase.
• Ensure that Molding Instructions and standard work are accurate and fully reflect the process.
• Complete product validations being capable of generating process window / IQ / OQ / PQ protocols and reports for new and existing product lines
• Troubleshoot molding and manufacturing processes and material issues. Work with internal and external resources to resolve molding and manufacturing issues and implement long term solutions.
• Review and coordinate New Product Releases and Engineering Change Notices for feasibility and cost concerning mold changes..
• Provides effective technical solutions for mold tool repair.
Job Skills
• Bachelor degree in an engineering related field
• At least 5 years of prior work experience in mold engineering related field
• Product/process sustaining and working in a medical environment preferred
• Strong knowledge in Validation processes (IQ, OQ, PQ)
• Molding process development
• Knowledge on Thermoplastic and Silicon process
• Experience in problem solving implementation
• Knowledge on statistical analysis
• Quality and process control knowledge and implementation (FMEA, CP, SPC)
• Experience in Six Sigma & LEAN
Job ID: 6063
