Manufacturing Engineering Manager - Exton, PA

Manage evaluation of scale up options, selection, & implementation by leading projects, providing project updates, and offering input for the next phases. Manage evaluation of potential new product/ process proposals and provide recommendations as to the scope and necessary timing required for specific production targets. Develop and review project plans, cost estimates, schedules, and resource requirements. Lead Manufacturing Reviews of new products and process improvements. Cultivate a team with the expertise to provide in-house development and/or technical leadership to Research & Development, Commercialization, and Operations Groups. Manage continuous improvement of products/ processes to achieve improvements in productivity, yield and/or operating costs. Manage annual goals/objectives. Perform Personal Development Reviews (PDR) on direct reports, fostering individual growth and development. Manage the preparation of applicable technical sections of regulatory documents (FDA 510k, IDE, PMA, CE), grants, & patent filings. Execute the job within the applicable DSM, OSHA, EPA, ISO, FDA, CE, & other requirements. Ability to apply Project Management techniques according to PMP. Ability to lead & manage and/ or function as part of a multifunctional and multi- departmental team. Proficient in the use of MSOffice, Word, Excel, PowerPoint, MS Project, IYlinitab, and SharePoint.