Senior Manufacturing Engineer - Medical Devices

Description Support cross-functional Product Development teams with technical inputs to product Design for Manufacturability, product design Hazard Analysis, process FMEA and manufacturing transfer planning.  RESPONSIBILITIES: •Lead Lean initiatives to eliminate Muda in existing and future manufacturing operations with Contract Manufacturers and internal manufacturing. •Coordinate plastics tooling and part debug efforts in mfg per corporate procedures and Standards. •Manage and resolve any issues, questions, or challenges to the manufacturing process. •Promote flexibility within the development process such that change is expected, reacted to quickly, and handled with ease. •Ensure that projects are completed on time and on budget. •Monitor the component supply chain such that parts are procured when and where they are expected. •Communicate often and effectively across all departments regarding projects the manufacturing group is involved in. •Utilize a high degree of systems thinking to constantly improve the present needs of the company in areas such as design control, engineering changes, purchasing and procurement, and the general quality system.

Requirements •Minimum BS degree in Mechanical, Plastic, or Industrial Engineering. •Minimum 5 years with a track record of leading cross-functional teams through to successful, on-time launches of novel new products, plus 5 years minimum experience in development and manufacturing implementation of disposable medical devices. •Hands-on, implementer type personality required. •Experience with transfer of disposable medical device production to offshore or domestic secondary source required. •Black Belt in Lean Mfg or 6 Sigma with Focus on Lean.  (A)Hands on experience value streaming and coordinating creation of value streams with Contract Manufacturers and other Manufacturing Engineers. (B)Hands on experience with Takt time vs. cycle times and cycle time reductions with single piece mfg assembly flows. (C)Hands on experience developing process flows. (D)Hands on experience leading and participating in Kaizen events to attack Muda. •Hands on experience working with Contract Manufacturers. •Hands on experience with Minitab. •Hands on experience developing assembly instructions. •Line layout experience. •Plastics Tooling, Processing, debug, secondaries and part Design for manufacturability. •(DFM)/Design for Assembly (DFA) experience. •Automation Experience. •Assist in engineering change orders by correcting documents and updating CAD model using SolidWorks. •Must have excellent communication, interpersonal and leadership skills. •Extensive knowledge of assembly and test methods and machines, in manual and semi-automated manufacturing environments. •Extensive knowledge of engineered plastic and metals materials for medical devices required. •Must have solid knowledge of FDA regulations and ISO compliance. •Must have working knowledge of CAD and basic computer spread sheets