Senior Manufacturing Process Engineer

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Company: Katalyst HealthCares and Life Sciences

Location: Holtsville, NY 11742

Description:

Responsibilities:
  • Manufacturing/process engineering.
  • Experience working with enterprise-wide tools like, Creo, Agile, Windchill, etc.
  • Automation and experience working with EMS (Electronic Manufacturing Services) companies.
  • Exposure to project management tools.
  • Design, develop, analyze, and implement manufacturing process in collaboration with Tier 1 suppliers or Distribution Centers.
  • Lead Tier 1 suppliers or Distributions center teams identify the root causes and resolution of manufacturing and quality issues.
  • Drive day-to-day manufacturing operation and New Product Introduction.
  • Supports various operational groups in cost reduction projects of Mass Production and New Products Introduction.
  • Drive continuous improvement to enhance quality, efficiency and cost using LSS and I4.0 as framework.
  • Lead, implement and validate Lean Six Sigma and Industry 4.0 maturity level with Tier 1 suppliers or Distribution Centers.
  • Drive process improvements using LSS and Industry 4.0 tools: for example: Line Balancing, Continuous Flow Line Layout, Point of Use, 5S, TPM, OMS, Cross training, CTQ, PFMEA, Automation, Digitization solutions, etc.
  • Conduct LSS & Industry 4.0 audits to measure maturity level and identify opportunities and gaps.
  • Work with internal and external teams to analyze and improve process focusing on root cause and eliminate the re-occurrence.
  • Manage Engineering Change, Deviations and MFGO process Evaluating the impact, risk, and material disposition.
  • Review and approve work instructions and validate the approved manufacturing process and parameter are correctly implemented.
  • Ensure production BOM is accurate and aligned with Agile references.
  • Drive Cost reduction projects implementation with cross functional teams.
  • Manage assets/fixtures/tools development/fabrication/validation/management.
  • Review and update Labor and MVA Models.
  • Make and implements recommendations to improve process capabilities for Mass Production and New Products introduction.
  • Develop positive relationships with other engineering disciplines and other functions for solving problems and innovative solutions implementation.
Requirements:
  • BS degree in Engineering (Industrial, Electrical, Mechanical etc.) with 4+ years of experience in Manufacturing Engineering/Process engineering /Industrial engineering/Logistics/ Distribution Centers/ Lean Six Sigma.
  • Knowledge/ Experience in with GMP (Good Manufacturing Practices) and working in Medical Devices, Personal Care, Consumer Electronics or Pharmaceutical manufacturing is a plus.
  • Strong Knowledge of Process/Industrial Engineering and Lean & Six Sigma (E.g., Design of Experiments & Root-Cause Analysis.
  • New Product launch and Project Management experience.
  • Process FMEA, Control Plan and Error proofing implementation experience.
  • Creating cost models and performing feasibility analysis.
  • Working knowledge for project payback analysis and financial justification - ROI.
  • Working with cross-functional teams including Product Development, Analytical, Safety, Regulatory, Technology Assurance (or equivalent), and Quality Assurance (where applicable), in a technical role.
  • Proficient in MS office software.
  • Green Belt as a plus.

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