CathX Assembler II

Zeus Industrial Products•San Jose, CA

About The Position

Job Summary 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 CathX Medical policies and procedures. This role complies to FDA QSR (21CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS). Responsibilities Reads work orders, follows production drawings and sample assemblies, or receives verbal instructions regarding duties to be performed. Ability to perform and demonstrate all Manufacturing procedures after training. Accurately complete all essential documents (i.e., Lab Notebooks, Device Master Records (DMR’s), Lot History Records (LHR’s), Inspection Records and Validation Documentation). Positions and aligns parts in specified relationship to each other in jig, fixture, or other holding device. Crimps, stakes, screws, bolts, rivets, welds, solders, cements, press fits, or perform similar operations to join or secure parts in place. Performs intermediate assembly tasks, such as pad printing, adhesive bonding, hot air bonding, balloon bonding, etching wires, swaging shafts, fusing skiving shafts, folding, marking, braiding, coiling, and perform leak testing. Adjusts and trims materials from components to achieve specified medical or dimensional characteristics. Performs online go-not-go testing and inspection to ensure parts and assemblies meet production specifications and standards. Packages finished assemblies or subassemblies in clear plastic bags. Meeting the daily goals and standards

Requirements

High School Diploma or equivalent work experience in the medical device industry
Experience - 3 years
Knowledge of Good Manufacturing Process and Good Documentation Practice
Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.
Must have the ability to calculate figures and amounts using basic math (i.e. decimals, addition, subtraction, multiplication and division).
Ability to use measurement tools like microscopes and pin gauges and to compare measurements to documented standards.
Good Manufacturing Process and Good Documentation Practice
Good written and verbal communication skills
Understands SOP's, MPI's and Work Instructions
Adherence to EH&S requirements
Basic Measurement Techniques
Basic Math Knowledge: Add, Subtract, Multiply Whole Numbers & Decimals
Assemble Small Parts Under a Microscope
Braiding
General Catheter Assembly Under a Microscope
Pad Printing
Bonding, Heat
Coil Winding
Laser Welding
Swaging
Balloon Folding
Balloon Blowing
Flaring
Tipping
General Inspection
Packaging
Labeling
Integrity, Accountability, Teamwork, Innovation
Good verbal and written communication skills
Ability to work independently
Ability to manage tight timelines and changing priorities
Demonstrate a quality culture within the team, ensuring that procedures and work methods for the area are accurate and fully complied to
Willing to be flexible and accommodating to meet the business need across shifts, while open to learning, and training in new processes as required
Demonstrated ability to work in a team and possess a positive communication style

Responsibilities

Reads work orders, follows production drawings and sample assemblies, or receives verbal instructions regarding duties to be performed.
Ability to perform and demonstrate all Manufacturing procedures after training.
Accurately complete all essential documents (i.e., Lab Notebooks, Device Master Records (DMR’s), Lot History Records (LHR’s), Inspection Records and Validation Documentation).
Positions and aligns parts in specified relationship to each other in jig, fixture, or other holding device.
Crimps, stakes, screws, bolts, rivets, welds, solders, cements, press fits, or perform similar operations to join or secure parts in place.
Performs intermediate assembly tasks, such as pad printing, adhesive bonding, hot air bonding, balloon bonding, etching wires, swaging shafts, fusing skiving shafts, folding, marking, braiding, coiling, and perform leak testing.
Adjusts and trims materials from components to achieve specified medical or dimensional characteristics.
Performs online go-not-go testing and inspection to ensure parts and assemblies meet production specifications and standards.
Packages finished assemblies or subassemblies in clear plastic bags.
Meeting the daily goals and standards