Provide support for all processes, new and old, to improve processes, reduce costs, improve quality, resolve process, tooling and CNC program problems, and provide necessary formal process documentation in compliance with GMP requirements and ISO Standard. This job includes providing training assistance, as required, for production management and supervision regarding process details, function, performance and control. The engineer will be responsible for many disciplines of support for production, coordination and documentation of new product transfers, prepare Capital Appropriation Request (CARs), and implement engineering changes.
Principal Duties and Responsibilities
•Coordinate all phases of product process introduction into production, including all manufacturing procedures and definitions.
•Provide training, as required, for manufacturing management or supervision and provide technical support in problem-solving situations.
•Conduct ongoing projects aimed at elimination of non-value added activities, reducing cost of goods sold, improving plant productivity, reducing cost of overhead, and improving product quality.
•Provide identification and preparation of operating procedures, OCPs, process control procedures, and any other information required to establish and maintain control of critical process parameters.
•Prepare Capital Appropriation Request for the implementation of methods and process improvement projects.
•Interface with the Warsaw development, Quality Assurance, Marketing and Manufacturing groups to provide the necessary support for cell product processes and new product transfers.
•Assists in the establishment of plant layouts for the purpose of improving work flow, methods, processes, and equipment utilization. Establishes workplace layouts for an efficient and smooth workflow.
•Prepares and verifies changes to the master router.
•Provide engineering support by troubleshooting problem and effecting timely solutions to maintain the continuity of production flow. This includes cell product processes and equipment.
•Prepare and provide support to cell processes and equipment validations.
•Develop and implement SPC programs, and work with the Quality Department to develop a barrier-free work environment.
•Interfaces with vendors and outside sales personnel to evaluate, cost estimate, and select raw material, tooling and equipment parts.
•Assist upper management in the establishment of cell and department goals.
Expected Areas of Competence
Ability to train and coach others. Must have project management skills. Computer literate. Knowledge of statistics and SPC programs, GMP and ISO standard. Good interpersonal skills. Team work and customer focus oriented. Good oral and written communication skills in English and Spanish languages.
Bachelor Degree in Engineering with CNC Systems experiences a must. Two (2) to five (5) years of work experience on process engineering, machining, metal fabrication using CNC mills and lathes. CNC programming and cellular manufacturing experience, desirable. Experience on Non-Destructive testing a plus. Experience on a regulated industry environment a plus.
Licensed Engineer and member of the College of Engineer of PR.
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