Katalyst Healthcares and Life Sciences
Responsibilities:
- Develop Standard Work for all injection molding processes and support activities and help train leaders in each functional area.
- Establish and maintain internal specifications and process documentation for injection molding processes and tooling ensuring processes and procedures are clearly stated and understandable for all employees
- Work closely with Product Development and Manufacturing to incorporate Design for Manufacturing (DFM) principals into all injection molded parts and assemblies
- Justify and generate capital expense proposals and manage capital projects for new machinery, automation and tooling
- Resolve technical tooling and process problems associated with both new and existing tooling. Hands-on technical resource for shop floor support when necessary
- Monitor and report issues with injection molds; make recommendations for refurbishment based on production factors such as cycles, process capability, and tooling history
- Validation Protocol & Report support. Preparation of validation samples as required;
- Create, support, and/or execute Installation Qualification ("IQ")/Operational Qualification ("OQ")/ Performance Qualification ("PQ");
- Support creation of Process Failure Mode Effects Analyses ("PFMEAs") and process control plans;
- Support Design Transfer Agreement Plan (DTAP), Process Assessment Tool, & Design Transfer Checklist. (6) Assist & Support New Product Introduction Quality Engineers ("NPI QE") with other NPI deliverables as requested;
- Creation/Release of validation/documentation in Valgenesis & OnePLM
- Bachelor's degree preferably Manufacturing, Industrial Engineering