Sr. Operator Assembler (Contract)

About the role

Cirtec Medical has been a leading outsourcing partner for complex medical devices since 1990. We specialize in comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Key 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.
• Takes direction within the manufacturing cell from upper-level operators assigned to that cell.
• Proficient in the task of loading components into product specific tools.
• Primary function, processing, and product fabrication.
• Performs 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.
• Performs pre/post-weld operations such as assembly and part cleaning.
• Performs workstation set-ups on qualified operations.
• Performs basic workstation set up and troubleshooting tasks.
• Performs various dimensional inspection using specific gauges, dimensional inspection systems, verniers and micrometers.
• May perform weld operations.
• Works with small devices to load fixtures and process equipment.
• Makes basic measurements and math calculations relative to tolerances, dimensions.
• Provides direction within the manufacturing cell to associates assigned to assist them.
• Assists Quality Control with inspection duties as required.
• Recognizes quality issues and communicates these issues to Quality and/or Supervisor.
• Accurately documents all work performed on inspection reports and customer travelers.
• Aids in packaging of finished goods as needed.

Qualifications

• High school diploma or General Education Degree (GED) is required.
• 3+ years’ experience in medical device industry and manufacturing required.
• Experience working with catheters.

Skills

• Read, write and speak fluent English.
• Frequent lifting and/or moving up to 10 pounds, occasional lifting and/or moving up to 50 pounds.
• Work in an environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise.
• Provide 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.
• Knowledge of ISO & FDA requirements a plus.
• Experience with LEAN manufacturing a plus.

Benefits

Cirtec Medical Corporation offers a wide range of benefits, including training and career development, healthcare and well-being programs, paid time off, and a 401(k) retirement savings plan with a company match. We also provide reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.