The Sr. Manager Manufacturing Engineering will be responsible for: • Ownership of operation engineering plan to improve production processes, upgrades in equipment/layout changes to optimize production flow and efficiency, expanded capacity to support growth, and product quality improvements to achieve production of safe, effective, and compliant IVD and RUO instrumentation. • Act at site for process engineer projects and activities that reduce safety risks, improve product quality/purity, enhance delivery capabilities and support cost improvements • Plans, implements, and executes engineering projects, including defining the project philosophy, activities, milestones, and staff requirements, per customer requirements. • Evaluate and select equipment to support process upgrades and new product introductions. • Partner with R&D as part of manufacturing transfer and scale up for new product introductions • Engage with manufacturing teams to find opportunities and provide improved production capabilities • Manage department and project budgets and implementation schedules to plan and forecast • Develop staff and improve capabilities/talent of the organization to meet current and future business needs. • Responsible for providing technical direction and functional management of manufacturing engineers and technicians assigned to the new product launch programs.What you will doPerforms required administrative functions, including preparation of annual capital expenditure budget, control of expenditures within approved limits, personnel administration and training, maintenance of required records and preparation of annual and special reports as required.Ensure effective engagement in design teams and fulfillment of design transfer responsibilities for new and changed product development, validation, and market release phasesEnsure effective prioritization and execution of sustaining engineering projectsManage external design transfers and contract manufacturing scenarios for processes coming into Luminex.Responsible for carrying out capital projects, engineering design, development of specifications, defines scope of work, project planning and execution, as well as organizing and coordinating resource schedules and budgets.Manage outsource process development/design transfer and contract manufacturing scenarios for processes going out of Luminex.Stay current in relevant technology fields and identify opportunities for process, equipment, and analytical innovations toward driving improvements in efficiency, quality, and customer satisfaction.Identify opportunities for business process improvements and efficienciesPerform cost/benefit analysis for product/process improvement projectsDeliver project proposals, assemble teams, and lead chartered projects as requiredLead development and implementation of process automation strategies and solutions.Assume full sustaining engineering support ownership for on-market processesParticipate in product feasibility collaborations with R&D, as needed.Lead and assist in engineering change control and document change control activities; participate in change control reviews.Collaborate with R&D on the development of material specifications, manufacturing processes, test methods, analysis tools, work instructions and related acceptance criteria for new or on market product Prototype release.Assume full design transfer ownership for Production and Market release of material specifications, manufacturing processes, test methods, analysis tools, work instructions and related acceptance criteria for new or on market product.Lead and drive design inputs and implementation oversight of infrastructure improvement projects.Establish and maintain standard architecture of BOMs and Routings to ensure accurate costing.Interface with Cost Accounting for new or existing product COGs roll-upCollaborate with R&D on OQ process validation planning and execution.Assume full ownership of PQ process validation planning, execution, and reporting; collaborate with R&D as required.Assume full ownership of test method and analysis tool validation planning, execution, and reporting; collaborate with R&D as required.Assume full ownership of equipment and test fixture validation planning, execution, and reporting; collaborate with R&D as required.Deliver primary and secondary packaging and labeling design support in collaboration with Commercial Operations and assume full ownership at Production ReleaseDeliver shipping configuration packaging and labeling design support in collaboration with Commercial Operations and Supply Chain. Assume full ownership at Production Release including shipping validations.Ensure assessment of change control training impacts and effective training for affected personnel.Ensure effective knowledge transfer of science, technology, and application context behind new product designs being transferred.Lead and support the investigation and resolution of findings impacting the organization identified through audits, non-conformances, corrective/preventative actions, or customer complaint escalation.Identify processes requiring statistical process control and implement control charts via Control Charting ProgramFacilitate development and drive execution of operational goals aligned with company objectives.Lead and participate in cross-functional teams supporting local and global business process integration, improvement, and alignment initiatives.Participate in or conduct applicable departmental, interdepartmental and intradepartmental training.Participate in departmental and Operations strategic planning encompassing organization, equipment/facilities, capabilities, and priorities.Ensure departmental compliance and influence operational compliance with the Luminex Quality System including FDA, USDA, and ISO 13485 requirements.Ensure departmental adherence and influence operational adherence to safety, waste disposal, etc.Other duties as assigned.Education QualificationsBachelor's Degree Minimum Bachelor of Science degree in a Mechanical, Electrical, or Industrial Engineering related discipline requiredMaster's Degree In Engineering or Business discipline preferredExperience Qualifications8 Years Quality Engineering, Process Engineering, and/or Product Transfer focused operations experience in a relevant ISO 13485 and/or FDA regulated industry setting. required5 Years Operations leadership experience with direct management of teams required3 Years Experience with electromechanical assembly manufacturing preferred1 Years Prior experience in optical designs and calibration preferredTraining and SkillsThorough knowledge of ISO 13485 and FDA Quality System requirementsProficiency in Enterprise Resource Planning and Manufacturing Execution systems desiredProficiency in the use of Product Lifecycle Management and Engineering Change Control toolsApplied knowledge of equipment, process, test method, cleaning, and software validations as required by FDA Quality System guidelinesThorough knowledge of Design Control requirements as defined by the FDA Quality System guidelinesProficiency in measurement and analysis systemsProficiency in data analysis tools, problem solving tools, and technical writingProficiency in statistical process control desiredProven expertise in design and implementation of infrastructure improvements desiredProven results through application of Six Sigma and Lean Manufacturing principles, including applied knowledge of statistical design of experiments desiredWorking knowledge of cost accounting desiredStrong mathematics and statistics aptitudeGeometric Dimensioning & TolerancingPLC programmingInjection molding and material coatingsExcellent oral and written communication skillsProficient in Microsoft Word, Excel, and PowerPoint programs.Highly organized with proven time management and prioritization skillsAbility to handle the pressure of meeting tight deadlines and adapting to rapidly changing prioritiesStandard Physical DemandsMust work onsite at Luminex office - ConstantlyWork is typically performed in an office environment possible exposure to Chemicals, Lasers, Excessive Noise, etc. - FrequentlyPossible exposure to mechanical, biological, and chemical hazards. - OccasionallyFrequent use of personal computer and office equipment - FrequentlyFrequent use of data and word processing programs. - FrequentlyFrequent standing, walking, sitting, listening, writing, typing, and talking. - FrequentlyLifting 20 to 50 lbs. - Frequentlyo Vision (Color) on the job is required occasionally - OccasionallyTravel Requirements10% Travel may be required