Manufacturing Engineer

Responsibilities: Perform equipment validation. Collaborate with Quality Engineering to provide manufacturing support. Responsible for providing manufacturing engineering support to specific projects including change analysis, risk analysis, and manufacturing readiness. Need to conduct qualification, verification, and validation activities to produce medical devices. Work with CFT teams in troubleshooting problems on the production floor. Design, develop, testing, and validate equipment and processes; analyze and interpret process models and recommend process improvements. Drive the execution of various validation and PFMEA activities as per the project plan. Execute Site acceptance test and Factory acceptance test based on North Haven Execute Validation Gap analysis of various product families based in Healthcare. Plan and initiate CDPs associated with the various validation activities. Coordination with stakeholders Collaborate with Quality Engineering to provide manufacturing support. Responsible for providing manufacturing engineering support to specific projects including change analysis, risk analysis, and manufacturing readiness. Should be experienced in conducting Time Study for various assembly line. Should be experienced in Medical device manufacturing assembly lines. Troubleshoot and resolve issues relating to the safety, efficacy, quality, cost, or delivery of components and finished devices. Need to conduct qualification, verification, and validation activities to produce medical devices. Need to be responsible for completing engineering work and contributing to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, six sigma, process studies, process improvements, and report preparation. Need to design, procure, and fabricate tooling and fixtures. Design, document, and improve manufacturing processes and operations that control the safety and efficacy of finished devices. Train, develop, and/or provide work direction to operators and technicians. Participate on cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions. Participate in design control efforts related to risk analysis (failure mode and effect analysis) & design reviews. Work with CFT teams in troubleshooting problems on the production floor. Need to identify and implement process/product improvement alternatives to increase/optimize yield, efficiency, throughput, and/or performance. Design, develop, testing, and validate equipment and processes; analyze and interpret process models and recommend process improvements.