Manufacturing Manager
Summary Our client, a Fortune 500 Medical Device Company, has engaged GForce Life Sciences to provide a Manager, Equipment Maintenance.
This position will report to a Sr. Manager, Engineering within the engineering department. This individual will be responsible for leading the manufacturing engineering group and the maintenance engineering & maintenance technical group, as well as be responsible for the installation, maintenance, calibration and troubleshooting of all manufacturing equipment.
This individual will also be responsible for developing strategies to detect and prevent issues that affect safety, quality, and throughput.
This position requires someone to take ownership of the operation engineering plan to improve production processes, upgrades in equipment / layout changes to optimize production flow and efficiency, expand capacity to support growth, and product quality improvements to achieve production of safe, effective, and compliant IVD and RUO instrumentation.
They will take ownership of the development and execution of validation protocols (IQ / OQ / PQ / PV) for production equipment,laboratory equipment, utilities, and other related systems in an FDA regulated environment, as needed.
They will Partner with R&D as part of manufacturing transfer and scale up for new product introductions and engage with manufacturing teams to find opportunities and provide improved production capabilities.
Duties / Expectations of Role Responsible for carrying out capital projects, engineering design, development of specifications, defining scope of work, project planning and execution, as well as organizing and coordinating resources and budgets.
Align manufacturing engineering, maintenance engineering, and maintenance technician support to match production schedules.
Ensure engineering sustains effective engagement with the design transfer groups of new and changed product development, validation, and market release phases.
For new product / process designs the manager is responsible for providing technical input to ensure product and systems are designed with safety, quality, scalability, and sustainability as a top priority.
Lead the industrialization of current and new processes. This includes lean process area design, development of process / production metrics and targets, visual management systems, etc.
Responsible for implementing robust change management systems to detect changes, control changes, and document changes made to the process and / or the equipment to protect validated state’.
Perform capacity, equipment efficiency, and labor utilization analysis to optimize manufacturing processes. Identify opportunities for business process improvements and efficiencies.
Maintain schedules for all GMP systems / lab equipment to ensure that they are requalified / revalidated / calibrated on time.
Responsible for the implementation and management of asset performance metrics (MTBF, MTRR, MTTF, OEE, etc) and visual management of KPIs.
Mandatory Requirements Bachelor’s degree in mechanical, electrical, or industrial engineering related discipline. 8+ years of manufacturing engineering, process engineering, maintenance engineering and / or product transfer focused operations experience in a relevant ISO 13485 and / or FDA regulated industry setting.
2+ years of leadership experience with direct management of teams 2+ years of experience with electromechanical assembly manufacturing 1+ years of experience with optical designs and calibration Thorough knowledge of ISO 13485 and design control requirements as defined by the FDA quality system guidelines.
PLC programming Nice to Have Six Sigma and Lean Manufacturing principles, including applied knowledge of statistical design of experiments.
Proficiency in enterprise resource planning and manufacturing execution systems. Working knowledge of cost accounting. Term & Start Permanent role Start date ASAP- 2 weeks from an offer Full time, 40 hours a week Onsite, Northbrook, IL Travel 10%, domestic Benefits included : Medical, Dental, Vision, 401k, PTO Two interviews Powered by JazzHR
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