Katalyst HealthCares and Life Sciences
Manufacturing Process engineer Job at Katalyst HealthCares and Life Sciences in
Katalyst HealthCares and Life Sciences, North Haven, CT, United States
Responsibilities:
Requirements:
- Participate in Design for Assembly (DFA) / Design for Manufacturing (DFM) activities to verify manufacturability of Product Designs.
- ctively 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.
- ctively participate in Lean initiatives to stabilize production lines and reduce the time to transfer to Plant.
Requirements:
- Experience in CREO to review custom tooling, fixtures, gages, and components.
- Review modification and development of Machine Specifications for manual, semi-automated and fully automated machines
- Basic understanding of Industrial Engineering principles including balance tables, process flow diagrams, line Client-outs, ergonomic designs, etc.
- Experience in assembly equipment technologies
- Experience with equipment and line process validations (IQ / OQ / PQ / MSA's)
- Working knowledge of Lean Principles and/or 6 Sigma Methodology
- Working knowledge of GD&T
- Working knowledge of FMEA
- Working knowledge of DFA and DFM principles BS Mechanical Engineering or Mechanical Engineering Technology
- BS Manufacturing Engineering or Manufacturing Engineering Technology
- 3 Years Applicable Experience for mid-Level
- 7 years Applicable Experience for Senior level
- Familiarity with statistical analysis including capability, process control, DOE's, control charts, etc. Minitab experience preferred, but not mandatory
- Experience or working knowledge of control systems, PLC logic, and vision systems.