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    Manufacturing Principal Engineer - North Haven, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences North Haven, United States

    4 days ago

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    Description
    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.
  • 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 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)
  • Ability to mentor and provide guidance to associate team members
  • Ability to work with fellow employees and suppliers on an international level.
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