Manufacturing engineer - Katalyst Healthcares & Life Sciences
North Haven, CT 06473
About the Job
Responsibilities:
- Participate in Design for Assembly (DFA) / Design for Manufacturing (DFM) activities to verify manufacturability of Product Designs.
- Actively participate in PFMEA, DFMEA, Process Mapping, and Critical to Quality (CTQ) reviews assuring specifications are well defined and documented.
- Create and review process flow charts, assembly tooling strategies, assembly line layouts, balance tables, assembly capacity analysis, and EHS project plans.
- Participate in the development of capital expense requests, project schedules, make-buy analysis and other financial documents.
- Provide input for all assembly tooling required to support new product development activity.
- Create, assemble, detail and review tooling and fixturing utilizing Creo and Solidwork's software.
- Develop and review defining documents, RFQ packages, interact with suppliers during the quoting process, ensure supplier adherence to tooling specifications, oversee manufacture and qualification of assembly tooling.
- Develop Protocols and execute Factory Acceptance Testing (FAT) on all purchased tooling, systems and fixtures.
- Manage and support line validation / qualification activities for including IQ, OQ , MSA and PQ.
- Write testing protocols for product evaluations; oversee and analyze product evaluation requests.
- Create process documentation including SWI, Control Plans and job safety analysis sheets.
- Actively participate in Lean initiatives to stabilize production lines and reduce the time to transfer to Plant.
Source : Katalyst Healthcares & Life Sciences