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. Hands-on (operating manufacturing equipment) processing experience with injection molding and elastomer extrusion 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 Salary band $79,500-102,000 Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor. #J-18808-Ljbffr