Manufacturing Engineer - integrated resources : Job Details

Title: Manufacturing Engineer Location: Exton PA Duration: 1 year( Possibility to extend to FTE) Shift: M-F 8am-5 Education: Bachelor of Science degree in Mechanical, Chemical, or Industrial Engineering. Other engineering-related degrees will be considered with relevant experience. Skills: 7+ years of hands-on experience in a fast-paced manufacturing environment, preferably in medical equipment or devices. • Demonstrated experience designing, building, and maintaining small tools and fixtures using Creo or related software packages. • Experience generating ideas, getting business support, and then driving the idea to an implemented solution. ccountability / Responsibility • Identifying and optimizing product/process variables required for maximizing product/process performance at prototype, lab/pilot, and full production scale • Leading evaluation of final product specifications by prototyping products/processes and performing experiments; from lab to production scale • Developing Client process/tooling concepts for new process development, and evaluate concepts based upon manufacturing key performance indicators (KPIs) • Proving product/process performance at prototype, lab/pilot scale, and full production scale • Leading evaluation of scale up options, selection, & implementation by leading sub projects, providing project updates, and offering input for the next phases • Evaluate, identify and recommend/implement improvements (productivity, efficiency, reliability) to existing processes (melt processing, chemical, machining or mechanical) or products. • Support research efforts related to identifying and/or evaluating new technologies, biomaterials and/or medical implants. • Support Operations to address plant layout, resources, and start up milestones • Developing all necessary documentation to support new/or improved process scale up to manufacturing verification • Design, assemble and test semi-automated and automated tooling required to improve current processes, or needed for new projects/product lines • Create and/or process ECN's, process routers, drawings, and other written documentation in accordance with GMP requirements to support product development, process development, validations and manufacturing. • Leading evaluation of potential new product/process proposals and provide recommendations as to the Product and necessary timing required for specific production targets • Developing project plans, estimating project costs, operating costs, project schedules milestones, and resource requirements. • Support customer quotations for new/changes to products/processes • Leading improvement of infrastructure and capabilities • Analyzing results of experiments aProductst objectives/targets • Working with supervisor and other associates to ensure execution of experiments in a timely manner • Leading Machine design verifications reviews. • Support Design Verifications, Design & Development reviews, and Verifications & Validations for new product development. • Providing in-house development and/or technical support to Operations • Conducting investigations and implementation of improvements into manufacturing product/processing issues • Support Operations in the daily manufacturing of commercial products. • Conducting investigation into customer complaints and resolution as it relates to manufacturing process, equipment or product requirements • Providing in-house development and/or technical leadership to Operations • Leading continuous improvement on projects/processes to achieve improvements in productivity, yield and/or operating costs • Leading investigation and perform root cause analysis into customer complaints • Support preparation of applicable technical sections for grants, patent, & regulatory filings • Leading Management of Change (MOC) review process • Participate on HAZOP and PSA teams as needed • Leading Machinery Safety Assessment (MSA) • Following Client Life Saving Rules (LSR), encourage fellow colleagues to work to the same standards. • Following Design Control and Risk Management procedures • Participate in auditing medical device design history files • Assist in the preparation of applicable technical sections of regulatory documents (FDA 510k, IDE, PMA, CE), grants, & patent filings. • Keep up to date on industrial and academic technological developments and exploring opportunities to incorporate them into process development/commercialization process • Directing or participating on project teams within the PMP/Project Management process • Execute the job within the applicable Client, GMP, OSHA, EPA, ISO, FDA, CE, & other requirements. • Directing or participating in a variety of projects with cross-functional project teams. Collaborating with Strategic Business Innovation, Strategic Business Management, Research & Development, Quality, Regulatory, Safety, Finance, & Manufacturing groups. • Participating on Engineering Change Notice (ECN) Board