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    Manufacturing Principal Engineer - North Haven, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences North Haven, United States

    1 week ago

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    Description

    Responsibilities:
    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. Travel to supplier sites as required. International travel required. Mentor and guide less experienced employees for professional development and advancement. Continue to enhance engineering and leadership skills through additional training, development projects, and education. Follow established guidelines and management direction with regard to engineering decisions and departmental / company policy.


    Requirements:

    BS Mechanical Engineering or Mechanical Engineering Technology BS Manufacturing Engineering or Manufacturing Engineering Technology 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 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 Exemplify team-work approach Dynamic, positive attitude Strong interpersonal, communication, project management and presentation skills Strong design, trouble-shooting, assembly tooling, and manufacturing process skills Strong computer skills (Microsoft Office, Project, Mini-Tab) bility to mentor and provide guidance to associate team members bility to work with fellow employees and suppliers on an international level.

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