Process Engineer

Apply by

2026-07-30

The Process Engineer follows good manufacturing practices (GMP) and principles to develop robust manufacturing processes. Has a primary role in the engineering of new or modified manufacturing operations in a clean-room environment.

Salary band $79,500-102,000

Tasks and 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.
  • Expert user of manufacturing equipment, intimately understands machine functions and can determine what equipment is required to produce a given product
  • Working knowledge of automation systems to be able to use and troubleshoot them once implemented by the automation team
  • Conducts reviews of new and revised tooling.
  • Acts as tooling design review input champion.
  • Develops and optimizes process parameters for new tools.
  • Develops process parameters for secondary operations such as ultrasonic welding, bonding, cutting, slitting, and testing.
  • Conducts data analysis and collaboration with Quality Engineering.
  • Understands process validation steps and goals and works with the quality engineering team to provide guidance on how to validate new production processes
  • Identifies Operational Qualification (OQ) process parameters and Performance Qualification (PQ) settings.
  • Develops and documents standard operating procedures and product-specific operating procedures
  • Trains manufacturing personnel on new production processes
  • 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.
  • 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.
  • Leads internal projects to investigate equipment or process related items
  • Understands basic material chemistry
  • Understands test methods used to inspect the products being produced
  • Works directly with customers to discuss topics such as design for manufacturing and material selection

Education and Experience

Required:

  • Bachelor's degree in Industrial, Manufacturing, Plastics or Mechanical Engineering or related discipline or 10 years equivalent work experience.

Desired:

  • Hands-on (operating manufacturing equipment) processing experience with injection molding and elastomer extrusion

Competencies

  • Ability to read, write and speak 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
  • Use of 3D modeling software such as SolidWorks
  • 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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