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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). 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 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
