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Assembler 2 - Manufacturing Operations Specialist
2 months ago
We are seeking a highly skilled and detail-oriented Assembler 2 - Manufacturing Operations Specialist to join our team at Route 92 Medical Inc. As a key member of our manufacturing operations team, you will be responsible for ensuring the efficient and effective production of medical devices.
Key Responsibilities- Manufacturing Operations Support: Provide cross-functional support to manufacturing operations, focusing on key performance metrics and process improvements.
- Line Setup and Training: Set up and train production lines, ensuring that all equipment and tools are properly calibrated and maintained.
- Product Assembly and Testing: Assemble and test products according to Manufacturing Process Instructions (MPI), Work Instructions, and Standard Test Methods (STM).
- Quality Control and Assurance: Accurately document work on Lot History Records (LHR) and manufacturing forms, and identify non-conforming units.
- Equipment Operation and Maintenance: Operate production equipment, such as hot boxes, laminators, and coil winders, and perform routine maintenance and calibration tasks.
- Problem-Solving and Collaboration: Collaborate with team members to resolve manufacturing-related issues and provide feedback to management and engineers on process improvements.
- Education and Experience: High school diploma or equivalent, with a minimum of 2 years of experience in medical device manufacturing.
- Skills and Knowledge: Ability to read and speak English, experience with GDP and GMP practices, ISO 13485 regulatory requirements, and Lean Manufacturing concepts.
- Preferred Qualifications: Understanding of commonly used concepts, practices, and procedures within the medical device industry, and experience with catheter production equipment.
