Medical Device Assembler
4 weeks ago
Route 92 Medical is seeking a skilled Medical Device Assembler to join our team. As a key member of our manufacturing operations, you will be responsible for assembling and testing medical devices, ensuring high-quality products that meet regulatory requirements.
Key Responsibilities:
- Assemble and test medical devices according to Manufacturing Process Instructions (MPI), Work Instructions, and Standard Test Methods (STM)
- Train new hires and other coworkers on manufacturing procedures and equipment
- Accurately document work on Lot History Record (LHR) and manufacturing forms
- Set up and maintain workstations, adhering to CER requirements
- Operate production equipment, including hot box, laminator, and coil winder
- Perform visual inspections and use basic measuring tools, such as calipers and snap gauges
- Identify non-conforming units and notify management
- Provide feedback to management and engineers on process and product improvements
- Problem-solve manufacturing-related issues
- Maintain manufacturing equipment in compliance with Calibration and Preventive Maintenance requirements
Requirements:
- High school diploma or equivalent
- Ability to read and speak English
- Experience and knowledge of GDP and GMP practices and ISO 13485 regulatory requirements
- Effective communication, interpersonal, and team skills
- Excellent attention to detail and organization
- Basic understanding of Lean Manufacturing concepts (Flow, 5S, Line Balance)
Preferred Experience:
- Minimum of 5 years of experience in medical device manufacturing
- Understanding of commonly used concepts, practices, and procedures within the medical device industry
- Ability to use microscopes, tweezers, razor blades, pliers, and other handheld tools for small parts
- Manufacturing device trainer
- Proficiency with use of equipment, such as hot box, adhesive dispenser/cure, laminator, coil winder, and pouch sealer
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