SUMMARY

Self-Motivated with a desire to learn and apply Manufacturing Engineering Principles by using a hands-on approach. Will assist with, process improvement and development, equipment support and maintenance, documentation, process implementation, problem solving, and training required to produce high-quality Medical Device components.

ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following.

Develop and Maintain Project/Work Plan

• Work with supervisor to develop a task list and estimated completion dates
• While performing daily activities, seeks to find ways to improve equipment or processes
• Keep ongoing communication with supervisor throughout the week
• Schedule weekly meetings with supervisor to review current activities and completion dates
• Maintain and adjust work schedule if priorities changes

Learn products, quality of products, equipment, and processes to which you are assigned

• Develop an intimate working knowledge of equipment and processes
• Spend time on the production floor to learn products and quality of products
• Learn and understand inspection methods
• Learn and understand the equipment, gauges, and fixtures required for inspection

Assist with the early and continued development of new products and processes

• Participate in teams to assist Product/Project Engineers with the development of new products and or processes
• Assist with feasibility studies
• Assist with specifying new equipment
• Assist with the concept design of fixtures or equipment
• Assist with testing and studies required to establish parameters and processes
• Assist to implement equipment, fixtures, and processes into manufacturing

Assist with the implementation of new equipment and processes

• Participate in protocol development and execution of equipment FAT, SAT, and IQ's
• Assist with process qualifications and validations (OQ's & PQ's)
• Assist with establishing parameters and processes
• Assist to development necessary documentations

Assist with writing documents required for the operation and maintenance of manufacturing equipment and processes (MPS's, TPS's, PMT's, etc.)

• Assist with the development of documents (verbiage, photos, diagrams, etc.)

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``` - Assist with ensuring the latest procedures are documented (Continue to update as required) - Learn to Route documents in Master Control - Learn how to follow documents through to approval

Training

• Develop Training Plan
• Complete Training course which allows you to train others
• Assist with Training Operators
• Assist with Training Technicians

Assist with Investigation and troubleshooting of manufacturing processes and equipment

• Assist with experiments
• Participate in meetings by communicating ideas, findings and suggestions
• Assist with the Implementation of Solutions
• Assist with writing reports (i.e. EST's/CAPA's)

Develop a working relationship with the following software:

• SolidWorks
• PDM Vault
• MS Excel
• MS Word
• Master Control
• MS PowerPoint
• Minitab
• Visio

General

Maintain and further develop a good work environment for all, through:

• Good verbal communication
• Your Actions
• Your Attitudes
• Your Behaviors

Comply with FDA, ISO and internal QSR requirements.

Enforce and contribute to a culture of safety and GMP compliance through technical specifications, training and awareness of standards and regulations.

Adhere to all Company policies, rules, procedures and housekeeping standards.

Other duties may be assigned.