Manufacturing Engineer

Fenton, MI 48430

Posted: 10/03/2019 Industry: Manufacturing Job Number: 62979

  • Ensure engineering documentation and manufacturing processes are accurate and appropriate for converting engineering design specifications to a product that achieves customer requirements; coordinate cross functionally as appropriate.
  • Develop, document and utilize proven manufacturing processes; conduct and document verification and validation processes as appropriate.
  • Utilize CAD to accurately document product or process specifications that are necessary to achieve design requirements.
  • Support and or engage in direct communication with customers to understand product to improve design for manufacturability and align process capability.
  • Analyze changes for feasibility and impact on specifications; implement approved changes as appropriate.
  • Control product and process specifications to comply with quality management system (QMS), FDA 21 CFR Part 820, and ISO 13485 requirements.

  • Product Design Support Contribute manufacturing process knowledge and experience to ensure requirements such as tolerances, fit, finish, etc. Are compatible with our process capability; assure cost estimates are accurate. Examples of this work include, but are not limited to:
    • Evaluate new products or proposed changes to existing products to confirm material requirements are compatible with Company process, identify concerns for manufacturability and recommend solutions/alternatives; support the estimating process as appropriate;
    • Participate or lead meetings (phone, video, or onsite) to understand and or refine product requirements with the objective of achieving manufacturability
    • Utilize CAD to create or edit designs and details to achieve a documentation package that can be understood and utilized by Manufacturing, Quality, Purchasing, and Sales.
  • Manufacturing Process Development and Documentation Optimize production processes to assure repeatability, reliability, and efficiency. Examples of this work include but are not limited to:
    • Determine and document process capability
    • Document production processes, document engineering masters in ERP system
    • Design, verify, and when appropriate, validate production tools, molds, and fixtures;
    • Determine sequence of operations, parts, tools and work instructions needed in order to achieve manufacturing goals according to product specifications; apply error proofing methods
    • Conduct and document process failure modes and effects analysis (PFMEA)
    • Engage with manufacturing subject matter experts to promote successful production integration
    • Develop proficiency with manufacturing equipment, write programs to optimize performance
    • Train manufacturing personnel on process work instructions and requirements
  • Continuous Improvement Assess products and manufacturing processes to identify, evaluate, and implement improvements to product quality and costs.
    • Utilize data to identify priorities to focus efforts for improvement
    • Utilize Lean Manufacturing tools to achieve manufacturing efficiency, improve quality, reduce scrap, increase yield, and reduce lead-times or cycle-time through the development of new processes, optimizing work flows, space requirements, and equipment layouts.
    • Collaborate with cross functional team members and as appropriate customers to implement improvements

  • Bachelors degree in mechanical or industrial engineering or proven experience in lieu of degree.
  • 5+ years-experience in manufacturing or mechanical engineering is preferred, experience with medical devices is beneficial.
  • Familiarity in the development of engineering and manufacturing processes.
  • Familiarity with Lean manufacturing principles.
  • Extensive experience with CAD (Preferred SolidWorks) and EPDM or equivalent is required.
  • Experience with CNC programming is desirable.
  • Technical writing experience is desirable.
  • Proficiency in Microsoft Word and Excel.
  • Must possess solid communication skills (verbally and in writing) and able to interface well with both technical and non-technical staff in various departments.
  • Possess excellent problem-solving skills.
  • Ability to organize work load and manage time effectively.
  • Ability to think analytically.
  • Displays a focus on quality and being a results-oriented individual.
  • Team player attitude with the ability to work constructively with other disciplines
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