Project Engineer - Medical Devices
We are searching for a Project Engineer for a highly regarded medical devices company in Wisconsin. This company is located in a growing suburban community of 35,000 in the Chicago-Milwaukee I-94 corridor within easy driving distance of Milwaukee to the north, Chicago to the south, and Madison to the west. It has been listed on Money Magazines "Top 100 Best Places to Live".
Our client is part of a large global chemical company and provides medical device contract manufacturing and support services to the healthcare industry worldwide. It specializes in silicone molding, precision medical extrusion of thermoplastics and silicone, and medical device assembly services.
The Project Engineer will:
- Manage projects utilizing project management tools in establishing timelines, building action item lists, assigning responsibility, completion dates.
- Working with cross functional teams, lead launch activities and manage feasibility meetings, including FMEA, PFD, part print review, tool design review and kaizen events
- Support costing engineer in determining most efficient manufacturing methods and tool design concepts
- Work closely with sales team and customers to clearly define customer requirements and specifications.
- Work with tooling vendors for mold builds that meet cost, quality and delivery expectations.
- Execute IQ/OQ/PQ protocols for new product, equipment, tooling, and processes.
- Work closely with Process Engineers developing new processes, tooling and manufacturing concepts
- Provide technical assistance and engineering support to the manufacturing floor in ensuring production of quality products.
- Lead process improvement and waste elimination efforts through application of lean principles
- Bachelor's degree in engineering
- 5+ years engineering experience
- 2+ years engineering experience in medical devices
- PMP certification or two or more years of experience in project engineering / new product development.
- Experience in new product realization, cost estimation, design and development of extruded, molded and/or assembled thermoset or thermoplastic materials. Familiarity with medical grade silicone materials preferred
- A depth of experience in interpreting, creating and modifying part prints and tool drawings.
- Strong understanding of GD&T, RMA and ISO standards. Auto-CAD or SolidWorks preferred
- Working knowledge of extrusion, molding and automated assembly equipment, with an understanding of mold and fixture design and build
- Previous experience in electrical, hydraulic and pneumatic systems.
- Good understanding of MSA, GR&R, visual measurement systems and ISO 13485 requirements preferred