Manufacturing Engineer II

SUMMARY DESCRIPTION

Provide Plant Engineering support for Visual Inspection Program activities. The Manufacturing Engineer will support manufacturing operations, process scale up, and manufacturing improvement activities. They will oversee projects to evaluate, analyze, and improve existing processes, and support the development of new manufacturing processes.

Skills:

For the 2 visual inspection related positions (Manufacturing Engineer II), the top 3 skills are:

1. Ability to prepare and execute engineering Studies, complex technical reports, project summaries, and correspondence

2. Experience with Visual Inspection

3. Excellent Communication with ability to work well in a team environment

ESSENTIAL DUTIES AND RESPONSIBILITIES:

" Assist in the overhaul of the process related to the visual inspection of in process products s from an engineering perspective.

" 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

" 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, write, review, and approve SOPs, specifications, and other documents to support the manual visual Inspection, packaging, and AQL sampling

" 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.

" 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

DESIRED MINIMUM QUALIFICATIONS:

" 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.

" 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. #J-18808-Ljbffr