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Coghlin Companies Senior Manufacturing Engineer in West Boylston, Massachusetts

Responsibilities: Under the direction of the Manager of Engineering, the Senior Manufacturing Engineer will: Provide engineering, operational, Lean manufacturing, Six Sigma leadership and mentoring. Lead by example and promote the criticality of strict compliance adherence at Cogmedix. Lead in the training of personnel, including customers and suppliers on workmanship and quality standards. Compliantly implement and maintain Cogmedix procedures. Collaborate with Program Managers, Manufacturing Engineers and other departments to analyze customer ECO?s and ensure effective implementation to the production floor through proper use of the Cogmedix ECO process. As part of the ECO Process and new proposal review, oversee the management of the customer BOM structure, creation of part numbers and structuring of Supplier Relationships and costs. Define PP/PA/Phantom, Commodity codes, documentation packages commodity and Work Instruction evaluation. As part of the ECO Process, oversee the generation and updating of DMR Indexes to ensure accuracy. As part of the ECO Process, provide ECO final approval for release. Oversee ECO implementation performance metrics. Effectively interact with customers and internal departments to create value-add propositions. Working with all internal groups, identify trends and process gaps and suggest and assist in the implementation of corrective actions and process improvements. Collaborate with internal groups and customers to help determine root cause of customer issues, Complaints, and CAPAs. Oversee and ensure prompt ME responses to manufacturing floor quality issues, taking appropriate action within the Cogmedix Quality System and continually building strong rapport with customers and suppliers. Oversee the development and approvals of optimal work order routings and Device History Records. Review redlined documentation and review prior to sign off. Lead and oversee complex troubleshooting efforts. Lead Manufacturing Engineers in the generation of Rework Instructions and review and approve prior to implementation. Generate the more complex Rework Instructions and assist when needed. Lead and oversee the development and deployment of Lean Manufacturing Cells. Working with the Quality Department, support the review of quality and inspection plans. Oversee regular audits of calibrated tools, tools requiring Preventive Maintenance and perishable floor stock items. Oversee the training of Assembly Technicians, Test Technicians on procedures as needed. ME oversight, management and scope of work for Scaled Product Launch/transitions. Oversee and review the generation of process validation/qualification documentation (e.g., validation protocols, IQ/OQ/PQ) and lead the implementation of protocols and completion of reports. Lead and oversee the preparation of Process Flows, PFMEA?s, Time Studies and Value Stream Mapping. Evaluate Product Performance Data and Internal Metrics for stability and continuous improvements, utilizing Six Sigma practices where appropriate, including SPC (statistical process control). Generate Manufacturing Engineering Bulletins to communicate Continuous Improvement Opportunities to customers. Contribute in DFcx exercises. Oversee and approve Risk analysis, Risk management and Risk reports. Oversee Customer Specific Daily Team Meetings. Oversee new customer documentation package review. Lead and oversee co-build activities. Assist in the containment of nonconforming product. Approve rework instructions and non-conformances. Review and approve Equipment enrollment forms. Train Manufacturing Engineers and Engineering Document Control Specialists. Support DFcx Engineering programs. Perform other activities as directed. Click Here for Full Job Description

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