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Senior Manufacturing Engineering Specialist

1 month ago

Canton, United States Cook Group Full time
Overview

The Senior Manufacturing Engineer plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure a quality product is produced in a timely manner. The Production Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, or improve quality.

Responsibilities

- Independently produce, organize, and maintain documentation or systems critical to the function of the engineering team or department.- Run short-term, long-term, and/or system-focused projects, or complete significant tasks critical to projects.- troubleshoot manual and/or automated processes and systems - Troubleshoot design, process, testing, and/or documentation issues.- Installs, qualifies, and validates equipment and processes in the production area to improve yield and/or reduce cycle time.- Support installation, calibration, qualification, and maintenance of the equipment- Define, implement, and support preventive maintenance activities. - Coordinate maintenance and facilities functions in asset management system- Assist with emergency and scheduled System Breach and Recover plan.- Develop or revise documents and procedures such as Drawings, Work Instructions, and Standard Operating Procedures- The integration of machined components with off the shelf parts to complete the equipment. (Keeping spares to a minimum)- The integration of electrical components. (HMI/PLC/Loadcell/sensors etc)- The integration of any pneumatic components into the equipment. (Cylinders/regulators etc)- The debugging of equipment PLC.- Assisting New Product Introduction Team to introduce new equipment into manufacturing.- Research and provide technical support of new automation/control technologies for implementation into new and existing equipment.- Liaise and communicate with the other project team members.- Ability to complete projects within specific timelines and meeting performance expectations.- Drive the development and execution of experimentation and testing to enable process characterization, optimization, and troubleshooting of processes and equipment- Build prototypes, develop manufacturing processes, perform testing, and/or develop appropriate documentation based on area of focus within the engineering department.- Use judgment and experience to independently accomplish project objectives.- Maintain high knowledge level related to the team's focus and relevant company systems. - Serve as a mentor, trainer, and resource to the team within area of expertise.- Prioritize work based on assigned goals- Read, comprehend and follow product and packaging specifications and manufacturing instructions and drawings.- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

Qualifications

- AS degree in relevant field; or experience of such kind and amount as to provide a comparable background.- 5+ years experience that relates directly to the above essential job functions/duties.- Knowledge of medical device quality standards/practices or similar regulated industry.- Ability to use machine shop equipment (milling machines, lathes etc) is an advantage.- Familiarity with 3D Cad package such as Creo/Solidworks is preferred.- Experience working independently and with minimal supervision.- Working knowledge of Microsoft Office Software (ie: Word, Excel).

- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.- Must strictly adhere to safety requirements.- Maintain regular and punctual attendance.- Must maintain company quality and quantity standards.- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.- Ability to remain calm and receptive in fast paced situations.

- Personal protective equipment including safety glasses, lab coat and gloves required in some areas associated with this position.- Sitting for extended periods, utilizes close visual acuity for working with computers, etc.- Works under general office environmental conditions.- Moderate exposure to noise level in the work environment that is moderate to occasionally loud.- Occasionally lifts and/or moves up to 50 pounds- Frequently required to stand, walk, use hands to grasp, carry, feel or touch; reach with hands and arms; talk and communicate.