CathX Assembler II

Job Title

Assembly Operators

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 (21

CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).

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

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

To perform the job successfully, an individual should demonstrate the following competencies:

Values:
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

Zeus Industrial Products, headquartered in Orangeburg, South Carolina, is the world's leading polymer extrusion manufacturer and material science innovator. More than 50 years of experience in medical, aerospace, energy, automotive, fiber optics, and more allows us to set the bar high. Zeus is a great place to work. Expectations are high; our work is meticulous and very precise. Zeus offers an opportunity to join a very successful, family-oriented team.

Our products are cutting-edge, our process is unique, and our quality and customer focus are second-to-none. We are a leader in our field and have great relationships with our customers and team members. Many of our team members are the best at what they do in the world. Our customers are leaders in their fields. Our products…