Location: Miami, FL
Experience: Mid Level, Senior Level
Education Requirements: High School Diploma/GED
OF THE JOB:
Working under general supervision and limited direction, follows oral or written instructions, performs repetitive bench or line assembly operations (including machine operations) to mass‑produce medical device products such as catheters, FEP, Expansion equipment, cut to length and/or Diagnostics catheters extruded components plus any associated subassemblies by performing the following duties. Needs to pass visual acuity and able to lift 30 lbs.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Performs complex tasks in the preparation for medical device assembly.
· Places parts in specified relationship to each other per written documentation.
· Assembles products according to approved standard operating procedures.
· Sets up, adjusts, operates, maintains and cleans complex machines to perform assembly process on assembly line. Able to perform complex set‑ups.
· Works at different workstations as production needs require.
· Works on line where tasks vary as different model of same article moves along line.
· Performs self-inspection on all assembly work performed.
· Conduct complex quality inspection of own or other's work.
· Perform complex first piece inspections utilizing test equipment.
· Has been trained on multiple workstations where at least three of the operations is consider complex and/or critical. Example Air Extruder (Coex, Vaccum, single ), Wire Ext (BC,TP), FEP, Cut to length, expansion equip. GC or combination of these training based on business needs
· Maintains clean and orderly workstation.
· Accurately records and completes all manufacturing documentation, i.e., logbooks.
· Gathers information and completes complex production reports as requested.
· Provides suggestions for improvement in operating time, yields, ergonomics, handling, line organization, etc.
· Performs stock/kanban transactions, and enters lot information into computer/terminal.
· May work with engineers on pilot run of assemblies. May perform assembly of custom special products. Must be capable of working to notebook and/or verbal instructions in pilot or laboratory environment.
· Interacts with other functional groups (i.e., quality) to resolve issues.
· Provides advice and guidance to less-seasoned associates. Trains lower level associates.
· Participates and may effectively lead team-based activities.
· Must be able to perform job functions while walking and/or standing up to 100% of the time during a shift.
· Has completed basic production, health, safety and environmental hazard training courses.
· Follows all corporate, safety and production standard operating procedures.
· Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
· Able to perform entry level PM”s using Maximo as “operator Asset care
EDUCATION/TRAINING and/or EXPERIENCE:
- High school diploma or equivalent. An Associate's Degree in an applicable field of study would be an asset.
- Mechanical or electrical trade and/or aptitude
- 5 or more years related experience and/or training; or equivalent combination of education and experience
- Must have successfully completed training as an Operations Associate - Intermediate
REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:
· Ability to work varying shifts and overtime as required
· Ability to read, write and understand English
· Must have ability to complete company/department-training courses
· Ability to work in a team environment
· Ability to read/interpret complex engineering drawings and other technical documentation associated with production.
· Ability to read and interpret machine performance test results
· Ability to interpret MSDS
· Ability to use optical comparator, video systems, and other magnification systems to perform assembly and/or inspection processes
· Ability to use and read measuring devices, i.e., rulers, calipers, micrometers, reticules, pull testers, thermometers, gauges, etc.
· Ability to distribute work and effectively convey instructions to others. Has ability to follow complex verbal instructions
· Understands and is able to apply regulatory (QSR, ISO) requirements in everyday activities
· Ability to use PC's and associated software, basic SPC