Manufacturing Engineer III - Katalyst Healthcares & Life Sciences

• Assist in the remediation of identified gaps related to operations and packaging for EU MDR technical files from an engineering perspective.
• Process engineering and project management to support remediation projects.
• These projects are typically of increased complexity and can pose significant risk to product and processes if not designed and implemented correctly.
• Complete projects aimed to evaluate, analyze, and improve existing processes, support the development of new manufacturing processes, and manufacturing process troubleshooting.
• Must be able to perform/deliver specific project tasks as necessary
• Ensure that all appropriate documentation, drawings, and specifications are generated in compliance with Integra's procedures and statutory requirements (US FDA and ISO).
• Coordinate specific efforts as required by the project team.
• Includes such tasks as development of manufacturing process requirements, specifications, validations, Engineering Change Orders (ECO) and Engineering Drawings.
• 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.
• Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture.
• 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.
• Provide technical input for analysis of process and equipment changes.
• 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.
• 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.
• Experience with Statistical Process Control tools required (SPC, Minitab, other software).
• 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.