CathX Assembler II

Zeus; San Jose (CA); On-site; USD 25,000 - 36,000; Full time

Benefits offered by this job

Benefits package

Team-oriented culture

Job summary

Zeus Industrial Products in California is seeking Assembly Operators to join a precision manufacturing team. Responsibilities include assembling medical components, following drawings, and documenting processes with strict adherence to GMP and QMS standards.

Candidates will perform tests, handle measurement tools, and ensure products meet strict quality requirements. The role requires focus, accuracy, and the ability to work with microscopes and small parts under tight timelines.

Qualifications

• High School Diploma or equivalent work experience in the medical device industry.
• Experience in a manufacturing environment is expected (3 years).
• Knowledge of GMP and GDP practices and Good Documentation Practice.

Responsibilities

• Read work orders and follow production drawings or verbal instructions.
• Perform and demonstrate manufacturing procedures after training.
• Complete essential documents (DMR’s, LHR’s, inspection records).
• Position and align parts using jigs or fixtures.
• Crimp, stake, screw, rivet, weld, or bond components.
• Perform intermediate assembly tasks and testings.
• Adjust materials to meet specifications.
• Conduct go/no-go tests and inspections.
• Package finished assemblies.
• Meet daily production goals.

Skills

GMP & GDP

Reading drawings

Basic math

Microscope inspection

Quality documentation

Education

High School Diploma or equivalent

Tools

Microscope

Pin gauges

Measurement tools

Job description

JOB DESCRIPTION

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 - 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.

Skills

• 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

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

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.

Continuous Improvement is a way of life at Zeus. Successful candidates will have a desire and ability to take our manufacturing process to the next level. Expectations are high; our work is meticulous and very precise. You must possess the ability to work independently; and the desire to learn a variety of skills. The ability to communicate clearly is imperative, as is the ability to manipulate data using various software packages.

At Zeus, what we do matters, and we pride ourselves in “Turning polymers into possibilities.” Expectations are high; our products are cutting-edge, our process is unique, and our quality and customer focus are second-to-none.

Our Employees And Our Customers Are At The Center Of Everything We Do. Those Relationships Have Been Built On a Foundation That Is Supported By Our Mission And Vision

Our Mission: Provide Solutions – Enable Innovation – Enhance Lives

Our Vision: Working Together – Doing It Better

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. Are you ready to join us?