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

Route 92 Medical Inc

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