Sr. Catheter Assembler/Operator

Sr. Catheter Assembler/Operator (Day shift) Contract - Santa Clara, CA Pay - $25 to $30/hr This position is primarily responsible for assembling product, associated systems, and basic operating of laser used in the manufacturing of products sold to our customers. This position is expected to work with and assist in the training of lower-level operators to effectively meet or exceed expectations for product quality and production rates. It is also expected that in this position they will continue to build their skills with Technicians along with taking tasks and direction from the Engineering departments. In this position you must be proficient in setting up and operating workstations and performing visual and dimensional inspections needed to manufacture the products. Essential Responsibilities Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System. Follow established documentation for product manufacturing. Maintain cleanliness of work areas, machines, tools, and equipment. Take direction within the manufacturing cell from Team Lead/Supervisor. Proficient in the task of loading components into product-specific tools. Primary function, processing, and product fabrication. Perform in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions. Operate a variety of wafer fab equipment in a production environment. Manually manipulate fragile wafers on a regular basis (site dependent). Work with small devices to load fixtures and process equipment. Make basic measurements and math calculations relative to tolerances and dimensions. Adjust machines to achieve conformance with specifications and maximum yield as instructed. Perform pre/post-weld operations such as assembly and part cleaning. Perform workstation set-ups on qualified operations. Perform complex workstation set up and troubleshooting tasks. Perform various dimensional inspections using specific gauges, dimensional inspection systems, verniers, and micrometers. Provide training on processes to team members. Operate manufacturing workstations including most laser systems used in the manufacture of products sold to our customers. Proficient in the operation of computerized motion controllers. Knowledge of welding operations. Perform workstation set up requirements for any type of processing job using existing tooling and established parameters. Working knowledge of drawings, ability to interpret nomenclature and dimensions. Provide direction within the manufacturing cell to associates assigned to assist them. Assist Quality Control with inspection duties as required. Accurately follow operating manuals, maintenance instructions, Standard operating procedures & work instructions. Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities. Perform additional duties as required under the direction of the Production Team Leader/Supervisor. Responsible for recognizing quality issues and communicating issues to the Quality and/or Production Supervision. Act as a resource during audits or customer visits for questions and answers or practical demonstrations. When assisting upper-level Technician or Engineer accurately document development activities in a lab notebook. Provide input to Engineering and upper-level Technicians regarding tool design and/or troubleshooting processes. Assist in ensuring the accuracy of Process Control Documents, Parameter Sheets, Work Instructions, and Standard Operating Procedures. Reliable, consistent, and punctual attendance is an essential function of the job. Comply with company, quality, and safety standards, policies, and procedures. Other duties as assigned. This is not a remote position. An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. Qualifications High school diploma or General Education Degree (GED). 3 years'experience working with catheters in the medical device industry and manufacturing. Be able to read, write and speak fluent English. Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Strong attention to detail. Understanding of

ISO & FDA

requirements a plus. Experience with LEAN manufacturing a plus. Ability to work in an environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise. Capable in providing detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action. Strong interpersonal skills to establish and maintain cooperative and effective working relationships. Good written and verbal communication skills. Experience in setting up and operating workstations. Moderate computer skills, including the MS Office suite. Must be able to interpret technical drawings, blueprints, specifications & illustrations. Strong analytical skills and must have the ability to obtain secondary research information from the Internet or alternate sources. Ability to learn and apply new technology. Technical report preparation. Strong understanding of performing visual and dimensional inspections. Working Environment Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.