What are the responsibilities and job description for the Assembler I position at Route 92 Medical Inc?
PURPOSE OF JOB:
- Provides the manufacturing operations team with cross functional support, primary focus on manufacturing key performance metrics.
- Daily tasks may include line setup, training, production assembly, coating operations, engineering runs, and material handling.
RESPONSIBILITIES:
- Uses hand tools, fixtures and equipment to assemble and test products per Manufacturing Process Instructions (MPI), Work Instructions, and Standard Test Methods (STM)
- Accurately documents record of work on Lot History Record (LHR) and manufacturing forms
- Sets up and maintains workstation; adheres to CER (Controlled Environment Room) requirements
- Operates production equipment such as coaters, hot box, laminator and coil winder
- Performs visual inspection and uses basic measuring tools such as caliper and snap gage
- Identifies units that are non-conforming and notifies management
- Provides feedback to management and engineers regarding process and product improvements
- Problem Solve manufacturing related issues
- Maintain manufacturing equipment in compliance with Calibration and Preventive Maintenance requirements. Support Equipment maintenance and qualifications, as needed
- Other duties as assigned; available to work overtime one Saturday per month at minimum.
REQUIRED EDUCATION AND SKILLS:
- High school diploma or equivalent
- Ability to read and speak English (i.e., read and understand manufacturing procedures)
- 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 2-5 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.
- Proficiency with use of equipment such as hot box, adhesive dispenser/cure, laminator, coil winder, and pouch sealer
