Assembler 2

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.