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Performance Health is seeking a Process Engineer to join our team. This position is a site expert and owner of manufacturing processes. Provides leadership and support for Quality and New Product Development projects. Leads initiatives to identify and improve the quality, production efficiencies, and safety of manufacturing operations. Essential Job Duties & Responsibilities Manufacturing Support: Experience with processes such as plastic and/or rubber sheeting and tubing extrusion, punch presses, water jets and injection molding. Create and maintain production processing conditions and keep them up to date within document control system Create and maintain production operating instructions and provide training on new or updated procedures Implement continuous improvement/lean manufacturing initiatives to drive improvement using tools such as: Six Sigma, 5-S, and Kaizan Develop, recommend, and implement measures to improve production methods, equipment performance, and quality of product Operate various pieces of pilot and manufacturing equipment in the development and evaluation of raw materials and finished goods Lead projects to continuously improve existing processes or create new processes to support operations, increase uptime, and reduce scrap Provide technical support as needed to production. This could include providing this service on any of 3 shifts or on weekends Interfaces with others in the organization to ensure customer deadlines, quality requirements, and production metrics are met Interface with facility cost accountants to assist them in developing costing assumptions as it pertains to materials, machine run rates, and labor content Interface with customers to understand their product requirements. Ensure that formulations and processes are in place to meet these requirements Interface with purchasing to identify and evaluate new and replacement raw material ingredients New Product Development: Work with NPD, Operations, and Account Managers to establish well-defined design inputs and coordinate sample runs on production equipment Provide technical leadership on corporate level projects and develop manufacturing plans and timelines for scale up of and release of new products Work directly with quality team to identify and implement control plans for new products Regulatory Support: Develop and execute Process Validation protocols and reports, fully documenting all IQ, OQ, and PQ activities for both existing and new processes. Actively participate on the validation team Lead PFMEA teams and own risk analysis activities throughout the plant Perform root cause analysis and lead teams assigned with addressing corrective actions Provide technical support during all external audits by FDA, ISO, and customers Participate as a member of the internal audit team by leading internal audits as well as participating/leading supplier audits Performs other duties as assigned Job Qualifications Bachelor's degree in Engineering 4-6 years of process or manufacturing engineering experience, preferably in a manufacturing environment Ability to use the following applications: Word processing, spreadsheets, Microsoft Dynamics AX, Netsuite, BPCS, and Document Control CNC Programming experience preferred Ability to travel 20-30& of the time, including overnight travel Benefits Our benefits include healthcare; insurance benefits; retirement programs; paid time off plans; family and parenting leaves; wellness programs; discount purchase programs. This is a full-time position with a base salary range of $90,000 - $105,000 plus benefits. To perform this job successfully, an individual must be able to perform each essential job duties satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accomm