Process Engineer

· Leads process development activities for all new products for silicone molded rubber applications including prototyping, validation using IQ/OQ/OQ, and launch efforts during entire product development process.
· Participates in related molding, inspection, characterization. and other manufacturing processes and generates all process documentation including work instructions, SOP’s, control plans, and PFMEA’s.
· Participates in validation protocol development and running of experimental tests for First Article samples and validation runs
· Communicates status with the engineering, quality, and sales team members to ensure project deadlines are met
· Identifies areas for improvement in equipment and processes, and works with the engineering team to implement solutions
· Trains manufacturing operators related to material, molding tools, and equipment for new and existing processes
· Troubleshoots existing process and implements improvement initiatives via cost savings projects, CAPA implementation, or lean/Six Sigma projects
· Cooperation and professional conduct with coworkers, staff, and managers.
· Meet our standards for quality and productivity.
· Follow all procedures for cleanroom operation, cleanroom attire, and contamination control.
· Follow all of our procedures for traceability, line clearance, process control, safety, and housekeeping.

· 5-7 years’ experience

· Must be motivated and creative, work well under pressure and operate effectively in a fast-paced team environment.

· Must meet internal deadlines and customer due dates

· Must have excellent interpersonal skills and ability to communicate needs and demands in an effective manner.

· Must be detail oriented, focused and able to produce accurate and professional documents

· Must have advanced skills in Microsoft Word, Excel, PowerPoint, and Minitab (or other statistical analysis software). Solidworks or CAD modeling software is a plus