Job Description

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)
• 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 in a team environment
• Operate 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 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 2 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.
• Experience with catheter production equipment such as hot box, adhesive dispenser/cure, laminator, coil winder, and pouch sealers, etc.

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