Process Engineer I
Medbio, Inc.
Job Category: Engineering , Manufacturing , Production , Technical The Process Engineer I is an entry level engineering resource for injection molding processes and associated equipment at Medbio. This role is intended to provide a foundation towards understanding engineering and manufacturing principles. The Process Engineer I will support daily operations as well as gain experience on more advanced topics. Major Duties and Responsibilities Gain and refine knowledge of injection molding processes and best practices. Become familiar with applicable requirements of ISO 9001, ISO 13485, OSHA, and FDA GMPs. Evaluate safety protecting personnel, customer property, and Medbio property from damage or misuse. Learn about the CIM system, data collection, analysis and its relation to manufacturing quality. Receive guidance and practice on new mold and takeover tool process qualifications, including: Providing input during project quoting and applicable design reviews. Suggested machine choice for qualification based on standard factors, including auxiliary equipment capabilities. Develop a statistically stable, capable process producing product to customer specifications. Troubleshoot and correct any tool or equipment related issues which impact product quality or project success. Adhere to all requirements in the SOP for Qualifications and/or customer approved validation protocols. Ensure documentation is completed in a timely fashion and available for qualification approval and close. Be involved in the evaluation of molding machines and auxiliary equipment. Suggest applicable outside vendors and sales personnel for troubleshooting and continuous improvement initiatives. Gain experience on an MRB team to determine proper disposition, root cause, and correction of non-conformances. Act as a Medbio representative with customers and vendors during audits or project development activities. Learn and demonstrate capabilities and functional skills on all automated equipment and systems. Discuss tooling related concerns and observations with peers. Seek knowledge to understand injection mold design elements and function. Provide assistance to Maintenance staff in testing repairs on equipment malfunctions. Provide technical training to staff as applicable. Serve on an off-shift to provide support and enhance technical troubleshooting skills. Learn and demonstrate elements of project management for assigned tasks from planning through completion. Support and adhere to corporate mission, values, and policies. Performance is reviewed both yearly and on a rolling basis by your ability to: Maintain harmonious relationships with other employees and departments. Provide training and support, where applicable, to shift leaders and technicians. Identify and follow through on opportunities for improvement in all production related processes. Occasional travel required, up to 10%. Perform other duties as assigned. Organizational Relationships The Process Engineer I reports directly to the Manager of Operations. The Process Engineer I should look to the Process Engineer levels II and III for training and mentorship in the pursuit of knowledge and experience. Experience and/or Educational Requirements Minimum of an Associate’s degree in a mechanical or technical field required 2 years’ experience in injection molding processing preferred Experience programming in C and PLC Ladder Logic is desired, but not Entry level knowledge of molds and mold design Entry level knowledge of part print reading and statistical methods, including the use of basic measurement tools Physical Requirements Must be able to work a standard 40 hour work week with occasional off-shifts and weekends as a possibility. Sitting and/or standing for an extended period of time as well as some walking within the facility. Must be able to see with or without corrective lenses and distinguish color differences and depth perception for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 100 feet. The ability to lift and carry various items up to 60 pounds. #J-18808-Ljbffr Medbio, Inc.
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