Process Engineer

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 DOE, 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.
• Owes tooling and process from a manufacturability standpoint from development to production release.
• Presents 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.

Qualifications

• 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.

Education and Experience

• 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.
• Proficient in use of problem solving tools such as 5-Why, Fishbone, 8D etc.
• Good understanding of manufacturing processes for medical components and devices.
• Good understanding of metrology principles and methods.