Description
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)
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.
Requirements
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.