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Manager, Maintenance & Manufacturing Engineering

The Manager, Maintenance & Manufacturing Engineering will be responsible for leading the manufacturing engineering group and the maintenance engineering & maintenance technical group. Responsibilities include:

• 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.
• 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.
• Responsible for the installation, maintenance, calibration and troubleshooting of all manufacturing equipment.
• Responsible for developing strategies to detect and prevent issues that affect safety, quality and throughput.
• 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.
• 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, maintenance engineers and maintenance technicians.

What you will do
  • Performs required administrative functions, including preparation of annual capital expenditure budget, equipment spares parts management budget, control of expenditures within approved limits, personnel administration and training, performance management, and managing communications with excecutive level staff.
  • 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.
  • Foster a challenging and rewarding work culture where engineers and technicians can grow and contribute to their maximum potential.
  • Responsible for career management/development and providing high quality performance reviews
  • Align manufacturing engineering, maintenance engineering, and maintenance technician support to match production schedules.
  • Responsible for driving team engagement, morale, and overall team effectiveness
  • Must be able to work flexible hours and respond to emergencies after work hours.
  • 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.
  • Mentor, coach, and train staff on validation practices, policies, and procedures required to support GMP operations
  • Lead the engineering teams to successfully deliver validations (IQ/OQ/PQ/PV) for production equipment, laboratory equipment, utilities, product labeling, product packaging, and controlled manufacturing environments.
  • Develop and manage project schedules to achieve aggressive program timelines by using parallel planning and leveraging cross-functional resources.
  • Responsible for implementing robust change management systems to detect changes, control changes, and document changes made to the process and/or the equipment in order to protect ‘validated state’.
  • Perform capacity, equipment efficiency, and labor utilization analysis to optimize manufacturing processes. Identify opportunities for business process improvements and efficiencies
  • Implement standard system for troubleshooting manufacturing processes/equipment and lead root cause investigations.
  • Drive the investigation and response of NCMR’s and related root-cause analysis to prevent recurrence that may result in poor quality or scrap.
  • Lead and support the investigation and resolution of findings impacting the organization identified through audits, non-conformances, corrective/preventative actions, or customer complaint escalation.
  • Recommend equipment purchases, repairs, upgrades, obsolescence, and maintenance schedule changes to improve equipment efficiency.
  • Lead the design and development of tooling, fixtures, jigs, etc. needed to improve the performance of the equipment and/or improve product quality.
  • Maintain schedules for all GMP systems/ lab equipment to ensure that they are requalified/revalidated/calibrated on time.
  • Responsible for the installation, troubleshooting and maintenance of all manufacturing equipment.
  • Responsible for the team that supports ‘line down’ calls. Ensure that production lines operate with minimum downtime and occurrences eliminated via robust solutions.
  • Maintain operating performance of production-related equipment according to manufacturer's preventative maintenance procedures and approved Company policy.
  • Responsible for the implementation and management of asset performance metrics (MTBF, MTRR,MTTF, OEE, etc) and visual management of KPIs.
  • Responsible for the deployment of Total Productive Maintenance systems using tools such as Reliability Centered Maintenance methodology.
  • Responsible for the accurate and timely documentation of all work performed in manufacturing equipment. Use data for trending and predictive maintenance systems.
  • Facilitate 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.
  • Establish and maintain standard architecture of BOMs and Routings to ensure accurate costing.
  • Interface with Cost Accounting for new or existing product COGs roll-up
  • Deliver shipping configuration packaging and labeling design support in collaboration with Commercial Operations and Supply Chain. Assume full ownership at Production Release including shipping validations.

Education Qualifications
  • Bachelor's Degree in a Mechanical, Electrical, or Industrial Engineering related discipline required

Experience Qualifications
  • 8+ Years Manufacturing Engineering, Process Engineering, Maintenance Engineering and/or Product Transfer focused operations experience in a relevant ISO 13485 and/or FDA regulated industry setting. required
  • 2+ Years Operations leadership experience with direct management of teams required
  • 2+ Years Experience with electromechanical assembly manufacturing preferred
  • 1+ Years Experience with optical designs and calibration preferred

Training and Skills
  • Preferred Training and Skills
  • Thorough knowledge of ISO 13485 and FDA Quality System requirements
  • Proficiency in Enterprise Resource Planning and Manufacturing Execution systems desired
  • Proficiency in the use of Product Lifecycle Management and Engineering Change Control tools
  • Applied knowledge of equipment, process, test method, cleaning, and software validations as required by FDA Quality System guidelines
  • Thorough knowledge of Design Control requirements as defined by the FDA Quality System guidelines
  • Proficiency in measurement and analysis systems
  • Proficiency in data analysis tools, problem solving tools, and technical writing
  • Proficiency in statistical process control desired
  • Applied knowledge of Six Sigma and Lean Manufacturing principles, including applied knowledge of statistical design of experiments desired
  • Working knowledge of cost accounting desired
  • Strong mathematics and statistics aptitude
  • Geometric Dimensioning & Tolerancing
  • PLC programming
  • Injection molding and material coatings
  • Excellent oral and written communication skills
  • Proficient in Microsoft Word, Excel, and PowerPoint programs.
  • Highly organized with proven time management and prioritization skills
  • Ability to handle the pressure of meeting tight deadlines and adapting to rapidly changing priorities

Standard Physical Demands
  • Must work onsite at Luminex office - Constantly
  • Work is typically performed in an office environment possible exposure to Chemicals, Lasers, Excessive Noise, etc. - Frequently
  • Possible exposure to mechanical, biological, and chemical hazards. - Frequently
  • Frequent use of personal computer and office equipment - Constantly

Travel Requirements
  • 10% Domestic