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Process Engineering Manager

Product Engineering Manufacturing & Distribution Akron, Ohio, US
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Performance Health is seeking a Process Engineering Manager to join our team. This position is a site expert and owner of manufacturing processes and process validation. Provides manufacturing process leadership and support cross-functionally for internally manufactured products across multiple site locations. 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 & ResponsibilitiesCoach and develop a team of direct reports (engineers and co-ops) to have both the technical capabilities to drive business results, and the resonant leadership to drive engagement and growthProvide engineering support to the existing processes and enable safe and efficient operation through application of engineering principles to our technical platformsCollaborate with peers to lead strategic development and continuous improvement of processing capabilities and systems. Manage resource allocation and project prioritizationWork with the Product Engineering group to ensure manufacturability and capacity of new product ideas and launches. Develop and maintain timelinesOversee the development and execution of Process Validation protocols and reportsOversee the documenting of the PFMEA, IQ, OQ and PQ activities. Maintain master validation plan to ensure products are being produced on validated equipmentInitiate 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 proProvide technical support as needed to productionParticipate on Continuous Improvement Team and lead Lean Manufacturing initiatives in the areas that full under the scope of responsibility for the Process Engineer Develop, recommend, and implement measures to improve production methods, equipment performance, and quality of product Interface 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 process are in place to meet these requirements Participate on the Validation Team and function as the manufacturing lead for process validation and process capability. Subject matter expert for all process validation during ISO, FDA and internal auditsDevelop and allocate department budgetPerforms other duties as assignedJob Qualifications Bachelor’s degree in Engineering5-8 years process engineering experience; prefer medical device industry experienceAt least 2 years of experience managing a teamHigh proficiency in Microsoft Office SuiteExperience using ERP systems, Minitab and Document ControlAbili
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  • Manufacturing & Distribution, Akron, Ohio, United StatesRemove