Process Engineer

Responsibilities:

  • Analyzes new product specifications and translates these into manufacturing processes to establish production rates, achieve expected quality levels and establish reliability of finished product.
  • Conducts reviews of new and revised mold tooling.
  • Acts as mold design review input champion.
  • Develops and optimizes polymer conversion process parameters for new tools.
  • Develops decoupled molding parameters to ensure process control.
  • Develops process parameters for secondary operations, including ultrasonic welding, bonding, and testing.
  • Conducts data analysis and collaboration with Project Engineering and Quality Engineering.
  • Identifies Operational Qualification (OQ) process parameters and Performance Qualification (PQ) settings.
  • Develops and documents standard operating procedures (SOP) and product-specific operating procedures (PSOP).
  • Trains manufacturing personnel on SOPs and PSOPs.
  • Performs DOEs, and participates in the development of control plans, Process Maps, and PFMEA documentation.
  • Organizes internal cross-functional teams and corresponding outside vendors needed to meet project needs. Procures equipment as needed.
  • Uses standard problem solving tools, e.g., 8D, 5 Whys, Fishbone.
  • Applies effective inter-departmental communication and escalation.
  • Owns tooling and process from a manufacturability standpoint from development to production release.
  • Partners with Quality department on investigation and corrective action for any failed First Article Inspection or OQ/PQ.

Qualifications:

  • 4 Year degree in Industrial, Manufacturing, Plastics or Mechanical Engineering or related discipline required.
  • Ability to read, write, speak and understand the English language
  • Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
  • Ability to demonstrate adequate job knowledge to deliver a world class performance
  • Ability to challenge oneself to consistently meet all goals and deadlines
  • Willingness to strive for excellence by producing work that is free of errors and mistakes
  • Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
  • Commitment to making improvements company wide
  • Demonstrated competence using Microsoft Office
  • Use of statistical analysis software
  • Interpersonal skills and good communication technique
  • Ability to coordinate multiple projects and deadlines, manage and identify scope
  • Act as a project leader on major projects
  • Lean Manufacturing- Proficient in use of problem solving tools such as 5 why, Fishbone, 8D, etc.
  • Understanding of manufacturing processes for medical components and devices.
  • Good understanding of metrology principles and methods.

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