Job Description
Job Description
PURPOSE OF JOB :
- Manufacturing operations cross functional support, focus on manufacturing key performance metrics.
- 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)
- Train new hires and other coworkers.
- 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 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
- Creation and redline of Operations related documents (WI, Form, Non-conformance investigations, etc)
- Other duties as assigned; available to work overtime as requested
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 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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