Assembler 2

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.