The NPI Medical Engineer is a new role within Kimball Electronics, Jasper. This position is located in Jasper, IN and reports to the Manufacturing Engineering Manager. It is a plant position that will be responsible for the introduction of new medical products from customer to the KEJ production floor. This engineer will interface with Product Managers, Process Engineers, Production and Quality to ensure a seamless first run and address issues going forward to improve upon initial success.
The NPI Medical Engineer will drive procurement of required unique tooling to support NPI and working with customer and suppliers for production requirements ensuring that all FDA requirements are met.
The primary function of this role is to drive processes and documentation for Medical NPI production assembly and ECN requirements and maintain revision control of products. The NPI engineer will work with the customer to ensure products are designed for manufacturability (DFM) and work with Customer to implement DFM recommendations. The NPI will also work with the Subject Matter Experts to design the processes necessary to successfully run all the customer’s products and to drive quality improvements and costs reductions.
This position will require:
Key Performance Objectives
- Minimum 5 years experience in Electronics Manufacturing.
- Strong mechanical and electronics knowledge and experience
- Disciplined problem solving approach
- Project Leadership skills
- Six Sigma Black Belt certification
- Thorough knowledge of Lean principles
- Thorough knowledge of FDA
- Previous Medical Device Introduction and Launch
- Proven success in running Kiazen events.
- B.S. degree in Industrial, Electrical, or Mechanical Engineering or equivalent experience
Short Term: (0 to 6 months)
Long Term: (6+ months)
- Work with Customer Focus Team to successfully learn the assigned customer and their products
- Work with Customer, Materials Group and Doc Control to Develop and maintain Bill of Materials (BOM's) for new and existing products and to rectify any material issues
- Own the Front line for Production product issues for given Customer, monitor health of production and initiate investigation of problem areas, and root cause product failures and drive corrective action.
- Coordinate technical review of product from customer
- Audit and Ensure that Kimball Systems are meeting FDA requirements
- Analyze defects to root cause and suggest design improvements and/or process improvements. Reduce PPM to below 500.
- Act as the primary technical interface between Kimball and assigned customers to support manufacturing of assigned products.
- Drive pre-production operation readiness, supporting product bring-up, providing training and gathering feedback on DFx and yield issues to Operations and Customer
- Ensure that all Delivery Requirements to the Customer are met. Drive 100% OTD.
- Complete ECO analysis for given customer and drive to implementation within 5 days.
- Drive changes to improve Kimball systems adequately meet FDA requirements and are best in class
Kimball Electronics Group - 13 months ago