The Product Builder is responsible for performing repetitive manual operations to assemble products to defined work instructions while meeting minimum KPI standards for productivity and quality. Some of these manual operations include, but are not limited to the following:

• Manual      rotary ultrasonic welding machine (Combo - Ultrasonic - Filter Welding)
• Automatic      filling and heat-sealing machine (TEC A) 
• Manual      heat-sealing machine (M. Heat Sealer Room 1&2 - Tommy N - Impulse      Sealer)
• Assembling      parts using epoxy, silicone, and glue
• Testing      Parts (Leak and Block)
• Die      Cutting (Blister Cutting - Filter Disc)
• Manual      bagging, sealing, and packing (Bagging - Bulk pouch - Bulk tray - Pouch      - FPO)
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Duties and Responsibilities: 

• Ability to read, understand, and follow      standard operating procedures and work instructions.
• Ability to identify common injection molding and      assembly line defects.
• Ability to perform 100% inspection and adhere to GMP and      GDP regulations.
• Comply with APO regulations and rules.
• Ability to communicate effectively and escalate issues      to production lead or supervisor.
• Perform routine cleaning to minimize particulate and      maintain a suitable clean room environment.
• Exercise good judgment by making sound decisions and escalating      issues when appropriate.
• Maintain attendance in good standing with a good      attitude and positive work environment.
• Other duties as assigned.

Required Qualifications:

• Must be able to read, write, and speak the English      language and be understood.
• Must be a team player and work well in a team      environment.
• Basic computer knowledge.
• Ability to multi-task and adapt to fast-paced work      environment.

Preferred Qualifications:

• High School diploma or equivalent.
• Work experience with a medical device manufacturer.
• Working knowledge of good manufacturing practices.
• Demonstrated initiative, self-motivation and can work      autonomously with minimal supervision.
• Injection molding or assembly operations knowledge.

Physical / Mental Demands: 

· The job is performed primarily in a cleanroom environment with no abnormal hazards or risks. Protective safety clothing is required, including appropriate dress code: no makeup or jewelry, shoe coverings, gloves, hairnet, and lab coat as needed.

· Must be able to work under conditions that require sitting, standing, walking, bending, reaching, pulling, pushing, and lifting up to 25 pounds.

• Must be      able to sit or stand for up to eight hours or throughout most of a shift      with occasional walking.
• Must      work on machinery with rotating parts.

· Work may require weekend and evening work.

· Must be able to work under stress and in a fast-paced environment.

· Must be alert, able to concentrate, and use good judgment.