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Experienced in assembling medical devices on two or more product lines at or above the quantity standard rate projected by the supervisor or lead.
Demonstrates an understanding of our Quality System Policies by referencing and explaining written line procedures.
Complete and maintain accurate written records of manufacturing operations on production documentation following appropriate training i.e. Device History Records, Data Sheets and Lot Control.
Understand and carry out instructions by their assigned Supervisor or Lead regarding priorities, work schedules, special assignments, job standards and related information required to build medical devices.
Adaptable to changes in procedures and is able to learn new procedures due to product line and technology modifications.
May be asked to cross train on a variety of product line operations.
May assist Assembler III or Lead in training procedures.
General understanding of LEAN Manufacturing Principals to assist in improving established metrics.
Proactively informs the lead or supervisor of material shortages.
Maintains a safe work environment by following and practicing good housekeeping and safety guidelinespolicies (e.g. ergonomics, job rotation, stretching exercises, tool handling and preventive maintenance).
Maintain acceptable standards for attendance and work overtime and varying shifts as needed.
Uses time effectively and constructively, does not engage in idle conversation that disrupts others and or the assigned operation, stays in the work area and does not abuse break times.
Volunteers in Shared Leadership activities. i.e. Kanban Management, Calibration, and Metrics Board Maintenance.
High school diploma or equivalent. 2 to 3 years of previous medical device assembly experience.
Must be able to communicate by way of telephone, e mail, or in person to supervisors, leads and team members.
Must be able to understand verbal and written work instructions.
Basic mathematical skills as required to perform job duties (add, subtract, multiply, divide).
Must be able to work in a clean room environment and follow the clean room environment practices and procedures.
Must be able to perform repetitive work according to set procedures, sequence and pace. Knowledge of GDP, GMP, and Lean Manufacturing preferred.
Maintains confidentiality of documents and processes.
Must have fine motor skills and high degree of dexterity and eye coordination to work with and assemble small parts and subassemblies using both hands.
Must be able to operate manufacturing and measurement equipment when applicable following appropriate training; not limited to: microscopes, test equipment, EFDs, ultrasonic welders, soldering irons, dial calipers, pressure gages, and rulers.
Basic MS Windows skills and site specific PC programs as required to perform job duties following training.
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EEOC and E-Verify