Process Engineer, Molding

Piscataway, New Jersey | Engineering

PROCESS ENGINEER, MOLDING

 

Our client is a successful Plastic Injection Molder with several facilities, providing components, subassemblies & assemblies to the Medical Device space.  This position will have a primary focus on the implementation of new projects (e.g. in calendar 2021 it will implement >20 new tools). Your “customers” will be internal and external; internally you will interact with the departments you are supporting and externally with the clients whose projects you are leading. 

 

Your experience with IQ/OQ/PQ, Validation & Verification, DOE’s and the use/application of RJG and/or Scientific Molding is imperative insofar as this is a “hands-on” engineering role.  Your ability to mentor by showing operators the steps/variables associated with the molding decision tree and subsequently document that information in concurrence with ISO 13485 tenets needs to be intrinsic to your personality and experience.  Our client understands that their success is dependent upon clearly defined strategies implemented by employees with an entrepreneurial spirit. 

 

RESPONSIBILITIES:

  • Follows the cGMP’s as defined by 21CFR and the company’s practices, policies & SOP’s to ensure FDA regulations are met and ISO 13485 certifications are upheld
  • In sustaining engineering, identifies opportunities for improvement and/or supports improvement projects using Lean/Six Sigma principals
    • Optimizes conditions by understanding the impacts of material temperature, flow rate, pressure and cooling as integral components of the tooling development process
    • Is involved with machine improvements targeting cost improvements through reliable, repeatable molding results
    • Surveys continuous or recurring runs to demonstrate ongoing Process Control working with QA/QC to analyze data and recommend improvements where needed
    • Writes and/or Supports Protocol Writing to provide objective evidence that equipment, process, test methods and final outputs meet design intent
    • In-depth involvement with Lean Manufacturing efforts for cost/lead-time/inventory reduction as well as quality improvements
  • In NPD ensures tooling designs meet the criteria needed to provide for repeatable manufacturing results
    • Drives process design during development, uses data-driven decision-making based upon results from SPC and other inspection modalities
    • Develops R&D testing and validation to predetermine process effectiveness and provide compliance to standards/regulations as well as providing verbal or written reports
    • Understands the outputs of tools like FEA, Stress/Fatigue and Mold Flow recognizing which data points will impact molded components
    • Develops training materials for new processes, materials and equipment providing the greatest probability of success to the manufacturing group
    • Designs and procures process specific tooling
  • Must be a strong communicator adept in situations ranging from outside to inside customers; reviewing material, tooling, fixturing, process capability and other issues including the need to effectively work with QA and outside vendors

REQUIRED EDUCATION & SKILLS: 

  • Bachelor’s degree in Engineering (prefer Plastics), Polymer or Materials Science
  • Minimum of 5 years hands-on experience including medical device manufacturing
  • Must have in-depth Injection Molding Experience
  • Trained and experienced in the use of RJG (eDart) or Scientific Molding
  • In-depth knowledge of V&V, IQ/OQ/PQ, DOE, Risk Analysis & SPC
  • CAD proficiency especially in 2-D and dimensioning
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