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Process Engineer II

Company: Biomerics
Location: Athens
Posted on: November 25, 2022

Job Description:

Description:General Summary -The Process Engineer II will be responsible for completing CIP's (Continuous Improvement Projects) and identifying opportunities to improve products or reduce costs using knowledge of fabrication processes, tooling and production equipment, assembly methods, quality control standards, product design, materials, and parts. Description of Responsibilities - Leads major product and process improvement initiatives from identification to execution with little to no supervision. Identifies gaps in processes, develops project plan, costs, and resources. - Develops and maintains key relationships across cross functional teams - Trains, coaches and motivates team members in the understanding and adoption of new Lean principles and techniques. - Ability to mentor and develop team members at lower tier levels - Managing/Executing process validation activities for IQ (installation qualification), OQ (Operational Qualification), PQ (Performance Qualification), and Gage R&R on medical devices per ISO and FDA regulations - Analyzes and maintains accurate workforce utilization, facility layout, and operational data such as production scrap trends, process flow charts, and other key production metrics to determine efficient utilization of workers and equipment. - Continuously improve current production methods using knowledge of product design, materials, tooling, production equipment capabilities, and other related metrics. - Manage cross functional teams within assigned projects - Refine project management methodologies for quality and project or program risk management - Manage and create timelines for project and task completion, as well as provide a means for tracking completion of project task and milestones - Utilize engineering methods (e.g., mathematical models, simulation, statistics) to support the design of optimal processes, identify and eliminate inefficiencies and non- value-added tasks, and ensure the maximum and efficient utilization of resources. - Draft and design layout of equipment, materials, and workspace to illustrate maximum efficiency using drafting tools. - Lead process development and project activities based on a clear understanding of the critical path of projects and recommend the allocation of resources accordingly. - Capable of working within the constraints of budget, schedule, and scope while managing risk and ensuring adherence to established processes and methodologies - Contribute technical expertise to development of overall project and departmental strategies - Must be able to author/co-author risk assessments and failure mode element analysis (RA.FMEA) per ISO-14971 - Analyzes manufacturing problems and customer issues related to design, process, and function, and interfaces with all aspects of engineering personnel to give prompt corrective solutions. - Interface directly with assemblers, leads, production supervisors, and production support team in resolving production problems - Work directly with Product Development and Technology Transfer to effectively launch new manufacturing lines within project due dates - Interface with Quality Engineering to determine critical manufacturing process and control characteristics. - Ability to complete hands-on tasks, up to and including actual equipment and pre-validation testing. - Additional tasks as assignedRequirements:Requirements - BS or higher degree in engineering: Biomedical, Industrial, Manufacturing, Mechanical or related field of study). - 2-5 years of experience in an Engineering or related field - Ability to handle tight deadlines, frequent assignment changes, periodic heavy workload, rapidly changing technology, and dynamic business growth - Ability to analyze and interpret 2D and 3D drawings - Strong understanding of statistical data analysis - Ability to effectively solve complex technical problems - Develop in-depth knowledge across multiple business units & technical areas. - Knowledge of statistical process control (SPC). - Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Medical Device Manufacturing Practices is preferred. - Experience using a systematic approach for Root Cause Analysis and demonstrated knowledge of systems/processes to ensure data driven decisions. - Excellent interpersonal and communication skills. - Some knowledge and experience with clean room environments /or process validation as related to sterile products and medical devices preferred - Experience with LEAN Manufacturing and Six Sigma Problem solving Methodology. Preferred Qualifications: - 2 - 5 years of Engineering experience in the medical device Industry. - Experience with design for manufacturability and assembly/design for six sigma (DFMA/DFSS) - Experience and familiarity with mechanical design using Solidworks - Six Sigma green belt certification - Understanding of Extrusion, injection-molding/polymer fabrication methods - Experience using project management tools to manage large and complex projects - Experience executing projects via a phase-gate analysis (Concept, Feasibility, Verification) using a risk-based approach (DFMEA) compliant with 21CFR/ISO-1497 - Experience facilitating the identification of project or program risks, developing and assigning responsibility for mitigation actions, and managing the mitigation plan - Experience interacting with customers, suppliers, and internal resources for medical device production

Keywords: Biomerics, Tyler , Process Engineer II, Other , Athens, Texas

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