Job Description

Job Responsibilities:

• 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 troubleshooting manufacturing processes. Must be able to perform/deliver specific project tasks as necessary
• Ensure that all appropriate documentation, drawings, and specifications are generated in compliance with Client’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

Skills:

• 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.

Education/Experience:

• Bachelor's degree in Engineering (Mechanical Engineering, Pharmaceutical Engineering, Chemical Engineering, Biomedical Engineering).

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