Assembler (Medical Devices)

Duties & Responsibilities:

• Assembly Operators are responsible for the assembly of medical components, subassemblies, products, or systems. Every team member is responsible for maintaining housekeeping and organization of the work area as well as following EH&S policies and procedures. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).
• Assembly Operators will need to document their work on travelers as the product move through the assembly process on the manufacturing floor
• Assembly operators will be working along side other operators, technicians, as well as engineering staff in order to improve the existing MFG process, as well as to identify bottlenecks in the process

Minimum Qualifications

• 2-5 yrs experience in Medical device MFG environment
• Experience with working in Cleanroom Environment
• Comfortable working under microscope for long periods
• Experience with handling of ESD sensitive devices
• Ability to perform and demonstrate all MFG procedures after training
• Accurately complete all essential documentation (LHR's, Inspection Records, Validation Documentation)
• Great manual dexterity skills
• Experience with conventional medical device MFG equipment (soldering irons, heat guns, hot box's, UV curing stations, tweezers, micro picks, etc).

Preferred Qualifications

• Experience working with flexible circuits, precision alignment processes
• Knowledgeable with precision soldering, ACF Bonding, thermal bonding processes
• Knowledgeable with PCB/PCBA rework
• Experience with SMT (surface-mount technology) manual processes