- High school diploma or equivalent. 2 to 3 years of previous medical device assembly experience.
- Must be able to communicate by way of telephone, email, 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.
- Successfully attained the knowledge, skills and abilities associated with the Assembler I job description.
- 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 guidelines policies (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.
- All Other Essential Duties as directed.