CL Room Operator

Valtronic Technology Inc
Solon, OH Full Time
POSTED ON 5/8/2024

Clean Room Operator

The Cleanroom Assembler is responsible for building, testing and documenting sub-assemblies and top level integration for Production. Disposable manufacturing is the assembly of mechanical components and the integration of electrical components. The Cleanroom Assembler works with Manufacturing Engineering and Supply Chain to ensure product is produced on time and according to specifications. The Cleanroom Assembler is responsible for the care and maintenance of the cleanroom and associated equipment. The Cleanroom Assembler is also responsible for ensuring all equipment and test fixtures are calibrated on schedule, and that raw materials are stored safely, properly, and clearly identified. The Cleanroom Assembler will flex to support the Medical Device Assembly Responsibility and will be cross trained as required to support business requirements. The Cleanroom Assembler acts as an incoming inspector as needed to support the business, can also serve as a receiver and inventory clerk for all production goods into and out of the Company. On occasion, this will include supporting the receiving and inspection of returned product, which needs to be investigated for errors, and reworked to production condition.

  • Assemble mechanical components, integrate electrical components, test and document all top-level product and sub-systems for production use by customers
  • Ensure all product is built and tested according to the documented procedures, and all forms are completed correctly
  • Maintain the cleanroom and all associated equipment. Including scheduling daily room maintenance for bioburden testing and air quality testing
  • Receive and inspect incoming materials for workmanship standard, and quality compliance
  • Perform final integration and testing of top level product based on instructions, as well as electrical safety testing of product before final shipping
  • Flex to support Medical Device Assembly
  • Support Lean and Health and Safety Initiatives
  • Provide support and feedback to quality and manufacturing engineering
  • All other duties as assigned

Valtronic Technologies is an Equal Opportunity Employer

  • 2-5 years of manufacturing experience in a regulated environment (ISO 9001) performing intricate (high dexterity) manufacturing, preferably in the medical device industry (ISO 13485)
  • 1-2 years of experience with catheter assembly or clean room assembly an asset
  • Exposure to electronic measurement and test equipment such as hipot, current leakage tester, and pressure leak tester
  • Ability to use common shop tools
  • Exposure to use of common mechanical measuring equipment
  • Logical thinking with creative problem-solving ability
  • Excellent written and verbal technical communications skills
  • Detail-orientated, highly motivated, patient and diligent
  • Able to work well in teams and independently

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