Sr. Manufacturing Engineer
Description
As Manufacturing Engineer, you develop and implement optimal, cost-effective manufacturing processes and methods in accordance with product specifications and quality standards; you recommend and implement improvements to our production processes, methods and controls; coordinate manufacturing launches for new or revised products.
Key responsibilities:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· Generate manufacturing documentation for new products. To include BOM, routers, drawing.
· Update current manufacturing work instructions, drawings, package labeling, and test procedures.
· Develop process improvements, generate new tooling and fixtures
· Implement Lean improvements
· Write, review and sign all engineering documentation
· Train manufacturing personnel as part of introducing new products/processes from the engineering phase to the production floor.
· Generate documentation and initiate validation of production methods.
· Provide engineering support and expertise in the investigation of nonconformances and CAPA
· Support manufacturing, documentation and quality personnel in ISO 13485, GMP controlled environment.
· Analyze existing manufacturing processes, identify and implement process improvements.
· Manage the Preventative Maintenance (PM) system
· Troubleshooting and problem solving
· Provide support to all production sites within the US
· Train and mentor Junior Manufacturing Engineers
· Other duties as necessary
Skills, know-how and experience:
· Must have worked in a manufacturing environment with some experience with product and/or process development.
· A mechanical background is necessary.
· Auto Cad, Solid Works, ERP or MRP experience is a plus.
· Medical device manufacturing experience desired. Design Transfer and plastic/molding experience.
· Must be proficient in using Microsoft Office.
· Experience working under a microscope is preferred