Advanced Manufacturing Engineer (AME) you will champion the manufacturability of new product introductions from product design to the serial production and is accountable for the practical application of design for excellence principles on the product/process development efforts. You will also be responsible for the formalization of manufacturing documentation, coordinating project schedules between R&D and functional teams in Operation (e.g., Supply Chain, Production, QA, Mfg. Engineering,) and lead the transition of new products into serial manufacturing, in quality, budget and time.
As part of your day to day you will:
Work as part of the development team to bring new products to market on time; in budget and within predetermined specifications.
Be core team member on the product development process (PDP) teams representing operations (Eng., Mfg., Procurement, Logistics) and is accountable for leading manufacturing core teams during the different PDP phases.
Be accounable for key operations related deliverables within the (PDP) including but not limited to Mfg Plan; Make/Buy decision analysis/recommendation; Capacity Planning; COGS estimation; Test strategy, Process Validation; Prototype Builds; Capital Equipment Specifications and Procurement; etc.
Be responsible for operations related activities and tasks within the PDP. Part of it, responsible on managing Operations project Gantt and timeline, task definition and synchronization between different matrix teams and functions; act as a main interface to R&D.
Be responsible and present project status to higher management.
Be a consultant on inquiries posted by team members related to manufacturing and testing technologies or other operations related processes.
Be accountable for the application of Design for Excellence (DFX) principles such as DFM; DFC; DFQ; DFT.
Apply methodologies such as Six Sigma and LEAN to identify, validate and improve defect sources in a variety of business processes.
Apply risk management methodologies such as DFMEA and PFMEA to identify actions that can be taken to eliminate or reduce the potential causes leading to failures.
Adhere to SOP’s and have the ability to prepare written policies, procedures, proposals, and reports in accordance with cGMP/FDA/ISO-13483 guidelines and regulations.
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