Manufacturing Engineer

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.

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 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