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Sr Process Engineer
Product EngineeringManufacturing & DistributionAkron, Ohio, US
Performance Health is seeking a Sr. Process Engineer to join our team in Akron, OH. This position is the subject matter expert for manufacturing processes and process validation by providing manufacturing process leadership and support cross-functionally for internally manufactured products. Leads initiatives to drive manufacturing improvements. Lead capex projects to acquire and implement new/modified manufacturing equipment.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 accommodations may be made to enable individuals with disabilities to perform the essential functions. Essential Job Duties & ResponsibilitiesDevelop and execute Process Validation protocols and reports, fully documenting the PFMEA, IQ, OQ, and PQ activities for both existing and new/revised processes.Create and revise product specifications and operating procedures to reflect results of process validationMaintain master validation planProvide technical support and act as subject matter expert for process validation during all external audits by FDA, ISO, and customersInitiate process engineering change orders and execute implementation plan from start to finish Operate various pieces of manufacturing equipment during the development, evaluation, and validation of raw materials and finished goodsInitiate new/revised equipment capex projects via business case development and lead project throughout acquisition/modification of equipment and implementationImplement continuous improvement/lean manufacturing initiatives to drive improvement using tools such as: Six Sigma, 5-S, Toyota production systemsLead projects to continuously improve existing processes or create new processes to support operations in the reduction of downtime and scrapProvide training and support for new/modified equipment and processesInterface with product managers and customers to understand their product requirements to ensure that formulations and processes are in place to meet the requirementsInterface with product engineering to complete both new design and design change requirements as pertaining to the manufacturing processInterface with sourcing to identify and evaluate new and replacement raw material suppliers and ingredientsPerforms other duties as assigned Job Qualifications Bachelor’s Degree in Chemical, Mechanical, or Electrical Engineering3-5 years of experience in a process engineering role2 or more years of experience leading and performing process validation in regulated industriesAbility to use the following applications: Word, Excel, PowerPoint, Minitab or other statistical software, ERP softwarePreferred experience in a medical device manufacturing environmentExperience with rubber mixing and milling and/or extrusion processingAbility to travel up to 10% of the time; including overnight travel Performance Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender, gender identity, sexual orientation, race, color, religion, national origin, disability status, protected Vete