CathX Assembler III

Zeus Company Inc.; San Jose (CA); On-site; USD 52,000 - 72,000; Full time

Benefits offered by this job

Competitive pay

Benefits package

Job summary

Zeus Industrial Products in Orangeburg, SC (global operations) seeks an Assembly Operator to build medical components and subassemblies. You will maintain clean work areas, follow FDA QSR/ISO 13485, and adhere to QMS policies.

Responsibilities include reading work orders, performing procedures after training, documenting records, assembling parts under fixtures, and ensuring parts meet specifications through testing before packaging.

Qualifications

• Requires high school diploma or equivalent and 5 years in medical device manufacturing.
• Knowledge of GMP and GDP required.
• Ability to read safety rules, operating instructions and procedures.

Responsibilities

• Read work orders and follow drawings or verbal instructions.
• Perform manufacturing procedures after training.
• Complete documents like LHRs, DMRs and inspection records.
• Position and align parts using jigs or fixtures.
• Crimp, stake, weld, or bond components as required.
• Perform intermediate assembly tasks such as bonding and ballooning.
• Trim materials to meet specifications and tolerances.
• Conduct go/not-go testing to ensure quality.
• Package finished assemblies and meet daily goals.

Skills

Good Manufacturing Practice

Good Documentation Practice

Reading blueprints

Measuring with microscopes

Basic math

Strong communication

Teamwork

Quality-conscious

Ability to train others

Self-motivation

Education

High School Diploma or equivalent

Job description

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.

Qualifications

• High School Diploma or equivalent work experience in the medical device industry
• Experience - 5 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.

Skills

• Good Manufacturing Process and Good Documentation Practice
• Good written and verbal communication skills
• Understands SOP's, MPI's and Work Instructions
• Ability to Train Others
• Work Without Supervision
• 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
• Injection Molding
• Bonding, Adhesive Bonding, Heat Coil Winding
• Laser Welding
• Grinding
• Swaging Skiving
• Balloon Folding
• Balloon Blowing
• Flaring
• Tipping
• Marker Band Placement-for Braided Shafts
• General Inspection
• Specialized Inspection
• Packaging Labeling

Competencies & Values

• 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

About Us

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 help save lives.

At Zeus, what we do matters, and we pride ourselves in "Turning polymers into possibilities."

Mission & Vision

Our Mission: Provide Solutions - Enable Innovation - Enhance Lives

Our Vision: Working Together - Doing It Better

Benefits

Zeus is an exciting, innovative company that offers competitive pay and a great benefits package. As we continue to push the boundaries of polymer science, we’re constantly in need of new ideas, new expertise, and new team members.

Closing

Are you ready to join us?