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Sr. Manager, Manufacturing & Mfg Engineering

Company: Endologix
Location: Irvine
Posted on: January 14, 2021

Job Description:

OverviewDirects and coordinates all production activities through subordinate supervisors, manufacturing engineers, and supply chain to attain production goals consistent with high quality, reliability, cost, and service levels requirements. Plans capacity (equipment and personnel) to ensure production needs are met and manufacture in a save work environment. Directly prioritizes work for engineers assigned to production support and/or new product development. Works closely with R&D teams and other cross functional groups to ensure timely introduction of new product transfer and/or new processes into Manufacturing. Directs the design and scale-up of processes, instruments, and equipment from concept thru commercialization and manufacturing scale up. Ensures resources are trained and capable. ResponsibilitiesEstablishes operational goals and objectives to meet production build targets. To include daily/weekly/monthly mfg dashboard metrices along with KPI targets.Provides direction and guidance to all production support groups relative to business requirements.Reviews production demands or schedules to ascertain production capabilities.Reviews and approve Document and Engineering Change Requests affecting manufacturing.Reviews production and operating results/reports to resolve operational, manufacturing, and maintenance problems. Compiles, stores, and retrieves production and quality data. Reviews and analyzes data and makes recommendations and implements changes based on data. Develops and monitors departmental budgets, both operating and capital against AOP targets.Directly and through subordinates manage the hiring, training and performance management processes for all Production and Engineering personnel. Ensure that accurate and complete records of department activities are kept and that they meet regulatory requirements.Identifies hazards and mitigates risks associated with identified hazards in Design and Process FMEA.Establish direction and strategies relative to product and process quality plans. Establish direction and strategies for introduction of new process/products into production.Represents the interests of the production environment within management and cross functional meetings.Monitors inventory goals (WIP, Kanbans, etc) to meet schedule requirements while minimizing investment and obsolescence exposure. Drives reductions in cycle times. Oversees execution of periodic WIP and cycle counts ensuring proper reconciliation with Finance.Ensures that scheduled delivery dates are met with minimum work-in-process time consistent with proper utilization of facilities. Keeps senior management informed on the status of production schedules. Directs, and clears away obstacles that create delay in production.Drive continuous improvements in production thru Lean Manufacturing and Six Sigma methodologies/best practices.Responsible for ensuring that subordinates follow all company guidelines related to Health, Safety and Environmental practices as well as company policies and that all resources needed to do so are available and in good condition.Follows all standard operating procedures. Make recommendations for additions and/or improvements to policies and procedures. Updates as appropriate.Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.Develops or revises standard operational and working practices and ensures compliance with standards.Oversees company goals and objectives, policies and procedures, Good Manufacturing Practices and FDA or other agency regulations. Maintains GMP compliance relating to Document Control, R&D, and Quality Assurance. Ensure that all regulatory and internal policies are followed. Participates in internal and external audits. Ensures self and team promptly address observations and/or required corrective actions.QualificationsProven track record of leading a team to consistently deliver high-quality products.Demonstrated leadership skills; clear examples of motivating, coaching, influencing, and developing team members at all levels.Strong project management skills, including the ability to prioritize, balance and manage multiple efforts with strong results/goal orientation.Strong communication and interpersonal skills; ability to effectively communicate complex information to all employee levels, and to set clear expectations.Extensive working experience with ERP System (preferably QAD) and Microsoft Office products.Experience with lean manufacturing (or similar) principles.Ability to work on abstract problems across functional areas of the business. Ability to audit production areas, identify non-compliance to requirements and develop and oversee action plans for corrective action.In-depth knowledge of Annual Operating Plan (AOP) planning cycle, such as resource capacity planning, department budgets (i.e. Labor, Expense & Capital), manufacturing cost accounting (i.e. standard cost, COGS).Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. In-depth understanding of production and quality control techniques including statistical process control.Has the ability to use moderate to advanced statistic techniques when analyzing data and make rational and logical decision base the that analysisApplicable knowledge of Minitab or other statistic toolsAble to read blueprints, schematics, and drawings. Applicable knowledge of Solidworks or other CAD software (not a requirement but a desirable skill)Job SummaryJob ID: 2020-2392Location: US-CA-IrvineCategory: Manufacturing

Keywords: Endologix, Irvine , Sr. Manager, Manufacturing & Mfg Engineering, Executive , Irvine, California

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