Manufacturing Process Specialist

2 weeks ago

North Haven, Connecticut, United States Katalyst Healthcares and Life Sciences Full time
Key Responsibilities:
  • Engage in Design for Assembly (DFA) and Design for Manufacturing (DFM) initiatives to assess the manufacturability of product designs.
  • Actively contribute to PFMEA, DFMEA, process mapping, and Critical to Quality (CTQ) evaluations, ensuring specifications are clearly defined and documented.
  • Develop and review process flow diagrams, assembly tooling strategies, assembly line configurations, balance tables, assembly capacity assessments, and EHS project plans.
  • Participate in the formulation of capital expenditure requests, project timelines, make-or-buy analyses, and other financial documentation.
  • Provide insights for all assembly tooling necessary to support new product development efforts.
  • Create, assemble, detail, and review tooling and fixtures using Creo and SolidWorks software.
  • Develop and review defining documents, RFQ packages, engage with suppliers during the quoting process, ensure supplier compliance with tooling specifications, and oversee the manufacturing and qualification of assembly tooling.
  • Formulate protocols and conduct Factory Acceptance Testing (FAT) on all procured tooling, systems, and fixtures.
  • Manage and support line validation and qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), Measurement System Analysis (MSA), and Performance Qualification (PQ).
  • Draft testing protocols for product evaluations and oversee the analysis of product evaluation requests.
  • Create process documentation such as Standard Work Instructions (SWI), Control Plans, and job safety analysis sheets.
  • Actively engage in Lean initiatives to stabilize production lines and streamline the transition to the plant.
Qualifications:
  • Proficient in CREO for reviewing custom tooling, fixtures, gauges, and components.
  • Review modifications and development of machine specifications for manual, semi-automated, and fully automated machinery.
  • Fundamental understanding of Industrial Engineering principles, including balance tables, process flow diagrams, line layouts, ergonomic designs, etc.
  • Experience with assembly equipment technologies.
  • Familiarity with equipment and line process validations (IQ/OQ/PQ/MSA).
  • Working knowledge of Lean Principles and/or Six Sigma Methodology.
  • Proficient understanding of GD&T.
  • Knowledge of FMEA methodologies.
  • Understanding of DFA and DFM principles.
  • Bachelor’s degree in Mechanical Engineering or Mechanical Engineering Technology.
  • Bachelor’s degree in Manufacturing Engineering or Manufacturing Engineering Technology.
  • Minimum of 3 years of relevant experience for mid-level positions.
  • Minimum of 7 years of relevant experience for senior-level positions.
  • Familiarity with statistical analysis, including capability, process control, Design of Experiments (DOE), control charts, etc. Minitab experience is preferred but not mandatory.
  • Experience or working knowledge of control systems, PLC logic, and vision systems.

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