CathX Assembler III

Zeus; San Jose (CA); On-site; USD 36,000 - 48,000; Full time

Job summary

Zeus Industrial Products in Orangeburg, SC, seeks Assembly Operators for medical component assembly and related tasks. Responsibilities include following work orders, assembling parts, and maintaining documentation to GMP and QMS standards.

The role requires the ability to read and interpret instructions, perform manufacturing procedures after training, and meet daily production goals. A high school diploma and 5 years in manufacturing are expected.

Qualifications

• High School Diploma or equivalent in the medical device industry.
• 5 years experience in manufacturing.
• Knowledge of GMP and Good Documentation Practice.
• Ability to read and interpret safety rules, operating and maintenance instructions.
• Ability to calculate figures and use basic math (decimals, addition, subtraction).
• Ability to use measurement tools like microscopes and pin gauges and compare measurements to standards.

Responsibilities

• Reads work orders, follows production drawings or verbal instructions.
• Ability to perform and demonstrate all manufacturing procedures after training.
• Accurately complete all essential documents (DMR, LHR, inspection records).
• Positions and aligns parts in jig, fixture, or holding device.
• Crimps, stakes, screws, bolts, welds, solders, cements, press fits, or similar operations.
• Performs intermediate assembly tasks: pad printing, adhesive bonding, hot air bonding, etching wires, swaging shafts, etc.
• Adjusts and trims materials to meet specifications.
• Performs online go-no-go testing and inspection to ensure compliance.
• Packages finished assemblies or subassemblies.
• Meeting the daily goals and standards.

Skills

GMP/GDP knowledge

Reading technical docs

Basic math

Measurement tools

Quality culture

Teamwork

Communication

Independent work

EH&S adherence

Microscope use

Education

High School Diploma

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).

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

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

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?

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