Job Description

• High school diploma or equivalent preferred with 1 to 2 years of previous medical device assembly or ISO-certified assembly experience.
• In lieu of a high school diploma, must have 2 to 3 years of previous medical device assembly or ISO-certified assembly experience.
• Must be able to communicate via telephone, email, or in person with supervisors, leads, and team members.
• Must understand verbal and written work instructions.
• Basic mathematical skills (add, subtract, multiply, divide).
• Must work in a clean room environment and follow related practices and procedures.
• Must perform repetitive work according to set procedures, sequence, and pace.
• Knowledge of Good Documentation Practice, Good Manufacturing Practices, and Lean Manufacturing preferred.
• Maintains confidentiality of documents and processes.
• Must have fine motor skills, dexterity, and eye coordination to work with and assemble small parts and subassemblies using both hands.
• Must operate manufacturing and measurement equipment when applicable, following training; includes microscopes, test equipment, EFDs, ultrasonic welders, soldering irons, dial calipers, pressure gauges, 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 Quality System Policies by referencing and explaining written line procedures.
• Complete and maintain accurate written records of manufacturing operations on production documentation following training (i.e., Device History Records, Data Sheets, and Lot Control).
• Understand and carry out instructions from the Supervisor or Lead regarding priorities, work schedules, special assignments, job standards, and related information required to build medical devices.
• Adaptable to procedural changes and learns new procedures due to product line and technology modifications.
• May be asked to cross-train on various product line operations and assist Assembler III or Lead in training procedures.
• General understanding of LEAN Manufacturing Principles to assist in improving established metrics.
• Proactively informs the lead or supervisor of material shortages.
• Maintains a safe work environment by following good housekeeping and safety guidelines (e.g., ergonomics, job rotation, stretching exercises, tool handling, and preventive maintenance).
• Maintains acceptable attendance standards and works overtime and varying shifts as needed.
• Uses time effectively, does not engage in idle conversation that disrupts others or operations, 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.

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