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Manufacturing Engineer III - Plainsboro, United States - Katalyst HealthCares & Life Sciences
Description
Responsibilities:
Assist in the overhaul of the process related to the visual inspection of in process products s from an engineering perspective.
SME for the visual inspection equipment/process and will perform various duties related to maintaining compliance and the continuous improvement of the visual inspection program
Ensure that the Visual Inspection Program operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements
Complete projects aimed to evaluate, analyze, and improve existing processes, support the development of new manufacturing processes, and manufacturing process troubleshooting.
Ensure that all appropriate documentation, drawings, and specifications are generated in compliance with Integra's procedures and statutory requirements (US FDA and ISO).
Support projects to implement statistical process control (as necessary), analyze and trend existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.
As required, conduct Non-Conformance Investigations, assist or lead in the prompt implementation of Non-Conformance resolution, and Corrective and Preventive Action(s) (CAPA support).
Participate and collaborate in technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs.
Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities.
Provide plant input in manufacturing process development, to include but not limited to, process design requirements, risk analysis, traceability matrix, design history file, etc.
Apply experience with manufacturing process equipment to lead the selection and/or design of equipment for prototype and full-scale manufacturing.
Evaluate and upgrade process equipment as required.
Utilizes scientific methods and statistical tools to perform investigations, root cause analyses, and impact assessments in support of timely resolution of deviations/discrepancies related to Visual Inspection
SME for the visual inspection equipment/process and will perform various duties related to maintaining compliance and the continuous improvement of the visual inspection program
Ensure that the Visual Inspection Program operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements
Execute other work as assigned by management
Requirements:
Bachelor's degree in Engineering (Mechanical Engineering, Pharmaceutical Engineering, Chemical Engineering, Biomedical Engineering).
3+ years of experience in manufacturing engineering within the medical device industry.
Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines, Engineering Change Controls, ISO, Design Control and Regulatory guidelines are required.
General chemistry, processing, and material expertise.
Considerable knowledge of the principles and practices of engineering as applied to various types of projects.
Ability to prepare complex technical reports, project summaries, and correspondence.
Exceptional practical problem-solving skills, excellent organizational and communication skills.
Experience with conducting 100% manual visual inspection, and ability to translate that expertise and train others
Desired:
experience qualifying a fully manual visual inspection process
Experience using and / or developing qualification kits and qualifying operators.
Manufacturing Process Optimization:
Lead efforts to optimize manufacturing processes, including equipment selection, process flow, capacity planning, and cycle time reduction to maximize efficiency and productivity.
Process Validation and Documentation:
Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing processes, ensuring compliance with regulatory standards.
Coordinate specific efforts as required by the project team, including development of manufacturing process requirements, specifications, standard operating procedures (SOPs), Engineering studies, Engineering Change Orders (ECO) and Engineering Drawings.
Lead technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Regulatory Affairs.
Continuous Improvement:
Identify opportunities for process improvement and cost reduction through the application of Lean methodologies.
Drive initiatives to enhance product quality, yield, and reliability.
Provide manufacturing input and support for the successful transfer of new products and processes into production.
Statistical process control:
analyze and trend existing process parameters, process inputs and outputs to improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.
Root Cause Investigations:
Conduct thorough investigations into nonconformances and product failures to identify root causes.
Utilize problem-solving techniques (e.g., 5 Whys, fishbone diagrams) to determine corrective actions and implement preventive measures.
Corrective and Preventive Actions (CAPAs): Lead the implementation and tracking of CAPAs.
Ensure timely completion of CAPA activities, including root cause analysis, action plan development, implementation, and effectiveness verification.
Compliance and Quality Assurance:
Ensure that all appropriate documentation, drawings, and specifications are generated in compliance with Integra's procedures and statutory requirements (US FDA and ISO).
Support internal and external audits to maintain compliance and address quality issues.Training and Mentoring:
Provide technical guidance and mentorship to junior engineers and manufacturing personnel.
Execute other work as assigned by management
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