Manufacturing Engineer |||
Katalyst Healthcares and Life Sciences - neshanic station, NJ
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Responsibilities and Requirements: Collecting, monitoring, analyzing, troubleshooting, and reporting manufacturing data related to performance in the areas of quality, cost, and speed/service to market Regular on-the-floor manufacturing support Identifying and implementing process and technology improvements to maximize process performance Investigating non-conformances, CAPAs, process performance drifts and implementing corrective and preventative actions Conducting Technical assessments of change orders and Supplier Change Requests Support and monitor Production as required to troubleshoot material, process and equipment problems including product loss and inefficiencies. Utilize technical abilities and experience, including the use of structured analytical techniques and technical tools such as data acquisition (manual and computerized), data analysis especially including process capability analysis, SPC and other statistical tools. Provide technical evaluations and support for Engineering Change Orders and Supplier Changes including updates to specifications, drawings and procedures and required operator training. Design and develop equipment and processes for use in the manufacturing of products. This may include in-house design, or the use of products or components purchased from vendors. Design, build and qualify fixtures, machines, or equipment to facilitate manufacturing capability of products. Support integration of new products into the manufacturing operation. Provide input to Development and Operations on materials, processing, the manufacture, and cost aspects of new products. Assist in the validation of new and revised manufacturing processes and equipment, ensuring compliance with all applicable company standards, procedures, and all other applicable specifications. Occasional travel is required to support continuous improvement initiatives. Significant Work Activities -Continuous standing for prolonged periods (more than 2 consecutive hours in an 8-hour day). A minimum of a bachelor's degree in an Engineering or technical field. 5+ years in the medical device or pharmaceutical field or 3+ years with an advanced degree.
Created: 2024-11-02