Maintenance Engineer - Us

Luminex, a DiaSorin Company is seeking dedicated and talented individuals with a proactive and positive ‘can-do’ attitude to join our team. If changing the diagnostic landscape and revolutionizing patient care sounds like something you would like to be a part of, we invite you to apply today! Together, we can help healthcare providers improve patient outcomes, make a difference in fighting the COVID-19 outbreak, and tackle the world’s most pressing health issues. You can learn more about our values, mission, and vision by visiting our website https://www.luminexcorp.com/about-luminex/ .
The Maintenance Engineer will be responsible for:
Apply fundamental engineering principles towards the maintenance and optimization of equipment and procedures to achieve better maintainability, reliability, and availability of equipment. Proven skills in the areas of equipment maintenance, equipment design, implementation of automated control systems, and equipment validations. Able to collaborate with vendors, suppliers, and internal cross functional teams to ensure effective validation, maintenance, and calibration of critical equipment per cGMP. Responsible for evaluating and optimizing equipment/processes to improve quality, consistency, and productivity. Support company goals, policies, and procedures while complying with applicable regulations. Responsible for assisting or leading the development and performance of validations on equipment. Supports applicable regulations including ISO13485, Local, State, and/or Federal requirements.
What you will do

• Lead the administration of Luminex's asset management system to ensure the maintenance system is compliant with cGMP, Luminex's quality system, and related regulations. Responsible for creating, maintaining and implementing periodic maintenance and calibration schedules.
• Perform other related duties as required or assigned.
• Perform capacity and equipment efficiency analysis to optimize manufacturing processes. Able to develop asset performance metrics (MTBF, MTTR, MTTF, OEE, etc) and create plans to improve metrics and performance.
• Responsible for performing assigned asks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies.
• Support manufacturing engineering in the development of equipment URS (user requirement specifications), as well as the development, execution and reporting of validation protocols (for installation qualifications, operational qualifications, performance qualifications and process validations).
• May supervise technicians. Responsible for enforcing all EHS policies in their span of control.
• Perform preventative maintenance and calibrations on equipment per asset management schedules. Perform updates in the asset management system to record all work performed. Use the asset management software to create reports for management.
• Lead initiatives to improve production processes to grow productivity, increase manufacturing yields, reduce production costs and decrease scrap. Collaborate with manufacturing engineering on automation projects to improve quality and manufacturing efficiency.
• Troubleshoot manufacturing processes / equipment and provide manufacturing engineering support to resolve production or equipment issues. Lead efforts to perform root cause investigations, troubleshoot issues and address root causes. Sustain record integrity of all issues and resolutions in the asset management system.
• Support the development of manufacturing processes by recommending equipment purchases, repairs, upgrades, obsolescence, best practices, and maintenance schedule changes to improve efficiency and cost within the manufacturing environment.
• Schedule and supervise visits from service contractors to perform repairs, maintenance, and calibration.
• Proficient in technical writing. Ability to write clear, concise and complete (detailed) manufacturing standard operating procedures (SOPs), technical reports, and other documents as needed.
• Use CAD to design tooling and fixtures in order to upgrade or repair an equipment or process.

Education Qualifications

• Bachelor's Degree Degree in Electrical, Chemical or Mechanical Engineering required

Experience Qualifications

• 2+ Years Experience in in-vitro diagnostics manufacturing, medical device manufacturing, pharmaceutical manufacturing or other related industries. preferred
• 1+ Years Experience with basic machine tools and machining desirable (mill, lathe, hand tools, etc.) required
• 2+ Years Proficient in PLC coding and troubleshooting. required
• 2+ Years Experience working in clean room manufacturing environments. preferred
• 2+ Years Extensive experience in process automation, equipment design, validation, and hands on maintenance. required
• 2+ Years Thorough understanding of quality control, process control, corrective actions, root cause analysis, failure mode effects analysis (FMEA), design of experiments (DOE) and asset performance metrics, and their application as a problem identification and resolution tool. required
• 2+ Years Experience with reliability centered maintenance. preferred
• 2+ Years Computer skills in Microsoft Office applications, asset management software, ERP software, CAD software and MINITAB. preferred

Training and Skills

• Ability to effectively present technical information and respond to questions from a variety of people that include managers, clients, customers, vendors and the general public. (High proficiency)
• Ability to handle and reason through complex information, define problems, collect data, establish facts, and draw objective conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. (Medium proficiency)
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and actor analysis. (High proficiency)
• Ability to write reports, business correspondence, manufacturing documents, maintenance schedules and standard operating procedures. (High proficiency)
• Ability to read, analyze, and interpret equipment manuals, electrical/ mechanical /P&I schematics, general business periodicals, professional journals, technical procedures and/or governmental regulations. (High proficiency)

Standard Working Conditions

• Must work onsite at Luminex office - Frequently
• Possible exposure to biological or chemical hazard, extensive noise, and/or working with lasers - Occasionally
• Work situations include dealing with people; working alone; making judgments and decisions; and directing, controlling or planning the activity of others - Frequently

Travel Requirements

• 10% Travel may be required

Luminex Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability status of an otherwise qualified individual, citizenship status, membership or application for membership in a uniformed service, or any other protected characteristic or category protected by applicable law.
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