Job Location : Exton,PA, USA
Duration: 1 year( Possibility to extend to FTE)
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.
Accountability / 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 novel 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 scope 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 against 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
• Following Design Control and Risk Management procedures
• Participate in auditing medical device design history files
• 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
• Directing or participating on project teams within the PMP/Project Management process
• Execute the job within the applicable 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