Manufacturing Engineer

Novozen Healthcare LLC
CA, United States
Full-time
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Title : Manufacturing Engineer

Location : Costa Mesa, California

Job Description : Responsibilities :

Responsibilities :

  • Lead and manage OQPQ and TMV processes as the primary engineer.
  • Oversee and guide cross-functional teams and shared resources to ensure project success.
  • Develop comprehensive project scopes, action plans, and allocate resources efficiently.
  • Collaborate with project engineers to execute tasks across various stages of project release, including new product introductions and sustaining engineering efforts.
  • Review customer designs to ensure manufacturing processes and procedures are optimized and compliant.
  • Conduct Design for Manufacturing (DFM) analysis, specifically for cable and wire harness sub-assemblies, and design associated tooling and fixtures.
  • Evaluate current processes to identify opportunities for automation or advanced tooling implementation.
  • Propose new materials (such as 3D printing) to improve processes, particularly within manual work environments.
  • Design or modify CAD models for manufacturing tooling and fixtures.
  • Develop detailed work instructions for both new and existing manufacturing processes.
  • Collaborate with customers to refine designs, enhancing manufacturability through adjustments in pins, tolerances, and processes.
  • Participate in customer meetings, providing expert insights on manufacturing processes and addressing Q&A.
  • Perform equipment validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Provide general support for additional activities related to New Product Introduction (NPI) as required.

Qualifications :

  • Background in both Project Management and Engineering.
  • Strong communication skills, both written and verbal.
  • Experience in interacting directly with customers, providing updates, presenting solutions, and driving project progress.
  • Ability to work with key decision-makers, ensuring alignment and progress on project objectives.
  • Skilled in prioritizing tasks, identifying critical issues, and organizing workload efficiently.
  • Capable of leading projects and taking ownership of programs to ensure successful outcomes.

Experience :

  • ISO 13485 : 5+ years (Required)
  • Manufacturing : 5+ years (Required)
  • 16 days ago
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