Changing lives. Building Careers.Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.The Process Engineer II is responsible for the following:
Responsible for engineering and project execution to support existing product transfers from the existing manufacturing facilities to the new CMC 109 Facility ensuring that well characterized and robust processes are put in place.
Collaborate with Product Development, Process Engineering, local plant Engineering, Quality, and Manufacturing stakeholders to ensure existing process issues are not transferred to the new manufacturing facility, and where appropriate, conduct characterization of processes/equipment. Ensure lessons learned are communicated and improvements are shared between the plants.
Drive the implementation of six sigma methodologies in the characterization of process to ensure robust and well identified CTQs.
Responsible for project management, process development, process improvement, IQ/OQ//PQ validations, developing and meeting transfer goals and metrics, optimization of the transfer process to ensure that new equipment and processes are delivered in an efficient, timely, and compliant manner with robust manufacturing processes.
Provide daily analytical and technical support to meet manufacturing objectives once products are transferred.
Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture.
Lead, support, and participate on special operations improvement projects as needed.
Apply experience with manufacturing process equipment to lead the selection and/or design of equipment for prototype and full-scale manufacturing working with outside suppliers.
Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities.
Ensure that all appropriate documentation, drawings and specifications are generated in compliance with Integra’s procedures and under current change control procedures as required.
Responsible for process scale up to plant standards and manufacturing volumes.
Assist in executions of validations, work orders, drawings, and procedures.
Qualifications:BS in Mechanical, Chemical, Electrical Engineering or equivalent combination of education and experience. Scientific degrees will be considered with appropriate work experience.
Two to five years of experience in a medical device or regulated industry. Experience in new Process and Equipment development preferred.
Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines, Engineering Change Controls, QSR, ISO, and Design Control and Regulatory procedures is preferred.
Experience in clean room automation, environmental control, and biomaterials a plus.
Exceptional practical problem solving, organizational and communication skills,
Expert Microsoft Office software and tools.
Experience in the application of robotics for manufacturing a plus.
Use of statistical process tools highly desirable. Minitab or Statgraphics a plus.
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