Manufacturing Engineer

Manufacturing Engineer IThe position of Manufacturing Engineer I is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will support manufacturing processes improvements, quality/cost savings initiatives while assuring compliance with cGMP, quality and safety standards.ResponsibilitiesWorks to identify root cause of manufacturing failures using structured problem solving.Evaluates machine logic, electromechanical systems and process controls to troubleshoot equipment.Supports design of experiments, validation, completion of testing and analysis of data for continuous improvement activities.Analyzes current equipment for process suitability and provides detailed plans for improvementCreates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to ensure compliant, efficient and safe proceduresWorks with other engineers and technicians in developing solutions and improvements in materials, equipment and process as necessaryActively participates in teams as necessary to ensure continual improvement, safety and complianceProvides training to technicians and operators on Standard Operating Procedures.Basic Qualifications | Education:Bachelor's degree (BS) in Engineering or equivalent combination of education and experience.Previous experience in an engineering role in a manufacturing environment.Familiarity with Database software; CAD software; Development software; Internet software; Inventory software; Manufacturing software; Project Management software; Microsoft Excel software and Microsoft Word software.Familiarity with a variety of material testing and measuring methodsPreferred Qualifications:Experience working in a GMP, FDA, ISO and USDA regulated environment.Familiarity with statistical analysis software (Minitab).Familiarity with cGMP and ISO 13485 regulations and practices.