Maintenance Technician

Job Scope

The Maintenance Technician is primarily responsible for supporting the Operations teams by providing maintenance and repair support. The Maintenance Technician will perform operations to install, troubleshoot, repair and maintain production and facility equipment according to safety and quality standards. He/she is expected to take ownership of the repair and maintenance of a wide range of production and development equipment, verify and document work performed, and administer and maintain a spare parts and calibrations programs for production equipment.

Key Duties and Responsibilities

• Administer and execute a Preventative Maintenance Program and Calibrations Program for the equipment
• Maintain a professional manufacturing environment for Medical Device Manufacturing
• Administer, develop, and maintain a Spare Parts program
• Read and understand electrical and pneumatic schematics, assembly drawings, data sheets, and process sheets to perform testing and troubleshooting of equipment.
• Troubleshoot Production Equipment problems,resolve, verify and document work performed.
• Maintain proper Equipment Documentation (Device Master Equipment Files) and maintain event records
• Quantify processing times and identify areas for process improvements.
• Assist with hands on training of manufacturing employees on new tooling, equipment and process revisions.
• Assemble and modify tooling, fixtures, and equipment.
• Assists with Facilities maintenance on an as-needed basis
• Assist Manufacturing Engineering in installing and validating equipment and processes in the production area following the established validation procedure.
• Assist Manufacturing Engineering in executing testing (FATs, SATs, IQ/OQ, Process and Product Qualifications and Validations).
• Comply with policies, guidelines and regulatory requirements with the Luminex Quality System including FDA and ISO 13485 requirements
• Interfaces/coordinates with departmental management to meet departmental maintenance objectives
• Provides guidance and resolution to technical or operational problems
• o Assist Manufacturing Engineering with revisions and improvements to manufacturing methods and procedures, including writing change orders and deviations
• Ability to work independently
• Interacts with various internal and external groups to facilitate the resolution of manufacturing equipment mechanical problems
• Ability to work flexible hours
• Adherence to SOPs, including safety, hazardous waste disposal, and gowning requirements.
• Other related duties as assigned
• Foresees issue before they surface; identify opportunities for equipment SPC.Mechanical and electrical aptitude

Education, Experience, and Qualifications

• H.S. Diploma Minimum High School Diploma or GED
• Bachelor's Degree Post-secondary education and/or a technical trade certificate preferred
• 2+ Years 2 years of experience working in a manufacturing environment with hydraulics, pneumatics, mechanics, high and low voltage electrical and PLC troubleshooting and repair
• 1+ Years Hands-on electro-mechanical assembly and troubleshooting experience
• 1+ Years Experience with basic machine tools and fixturing desirable (mill, lathe, hand tools, etc.)
• 1+ Years Experience working in a regulated environment (FDA, etc.)
• 2+ Years 2 years in FDA regulated environment
• 1+ Years Experience working independently in a fast-paced environment with rapidly changing priorities

Training and Skills

• Ability to utilize illustrated parts breakdown manuals and operational manuals in the repair, modification and maintenance of equipment
• Great attention to detail and commitment to excellence in review and work product
• Ability to write detailed repair reports and records activities in the ERP system
• Must have good mathematical skills, including basic algebra, to calculate electrical/electronic, fluid dynamics, and pressure equations as needed
• Proficiency with the appropriate CAD software according to discipline.
• Proficiency with Microsoft Office applications.
• Thorough understanding of machine component design
• Highly organized with proven time management and prioritization skills
• Ability to work independently and with minimal supervision
• Ability to excel in pressure situations to meet tight deadlines
• Familiarity with cleanroom operations desired
• Familiarity with fluid handling equipment and chemical/analytical equipment desired

Standard Physical Demands and Working Conditions

• Standing - Occasionally
• Stooping - Occasionally
• Bending - Occasionally
• Climbing - Occasionally
• Sitting - Occasionally
• Kneeling - Occasionally
• Lifting of at least 40lbs - Occasionally
• Must work onsite at Luminex office at least 90% of the time - Frequently
• Possible exposure to biological or chemical hazard, extensive noise, and/or working with lasers - Frequently
• 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