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Engineering Tech - Packaging at Arthrex Manufacturing, Inc.

Posted in Engineering 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Ave Maria, Florida

Job Description:

Requisition ID: 41731 
Title: Engineering Tech - Packaging 
Division: Arthrex Manufacturing Inc (US02) 
Location: Ave Maria, FL

Arthrex Manufacturing is current seeking Engineering Technicians for our manufacturing facility in Ave Maria, FL. The Manufacturing Engineering Techs will be responsible for supporting the Packaging Engineering department by assisting engineers with the life cycle development of Class I and II medical devices, including new product development and maintenance of released products.   They will also support programs, policies, and procedures in order to help the growth of AMI as a world class medical device manufacturer.

Essential Duties and Responsibilities:

  • Responsible for supporting Packaging and Process Engineering with the development and execution of final assembly and packaging equipment and required validations. 

  • Support Engineering with equipment troubleshooting/start-up processes.

  • Assist with the creation and processing of Engineering Change Requests, including engineering specification drawings, all associated components that comprise equipment/tooling, and packaging process routers.

  • Execute validation protocols (DOE/IOQ/PQ) for new product and new equipment/automation projects. Record and report quality and reliability data accurately per written protocols and data collection forms provided.

  • Responsible for supporting validation protocols by producing and testing samples. 

  • Responsible for production support and troubleshooting of final device assembly and packaging/labeling operations.

  • Support production in the inventory of tools, prototype parts and fixtures to prevents outages and ensure validated configurations are maintained.  Support engineering to ensure changes to tools and fixtures are properly documented prior to change and/or validation activities.

  • Assist engineering keeping precise identification and control of validation samples and validation work orders and ensures work orders documentation is consistently accurate.

  • Report progress and status of assignments on a timely basis with emphasis on reporting results to Engineering project leaders as appropriate.

  • Comply with ISO/FDA and internal quality assurance policies and work instructions.

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

  • High school diploma or equivalent required.

  • Associates degree or some college experience is preferred.

  • Microsoft office suite proficiency is required (Word, Excel, Outlook).

  • Experience with Medical Device Packaging or device manufacturing is preferred.

  • Lean Manufacturing/Kaizen and Statistical Analysis preferred.

  • Experience with engineering specification documents and conventions preferred.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

  • Experience with packaging materials and processes, BOMs/Routers, and ability to read blueprints preferred.

  • Design of Experiments and FMEA working knowledge preferred.

  • Knowledge on the following processes: pouch sealing, blister sealing, burst testing, pull testing, dye penetration testing, labeling application and printing, boxing, RFID/HID barcode scanning, manual and automated assembly processes, special assembly fixtures and tools, etc. preferred.

Machine, Tools, and/or Equipment Skills:

Pouch and blister tray sealing equipment, package testing equipment, dye penetration testing, label printing equipment; laser equipment, automated equipment.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

Ability to comprehend and apply mathematical principles using a calculator to the degree required to perform the job based upon job requirements including: addition, subtraction, multiplication, calculating percentages, and interpreting decimals.  Knowledge of basic statistical analysis is preferred.

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.  Ability to verbally communicate ideas and issues effectively to other team members and management.  Ability to write and record data and information as required by procedures.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand for 8-10 hours per day wearing gowns, hairnets, and gloves; use hands and fingers, to handle, or feel; and reach with hands and arms.  The employee must frequently lift and/or move up to 20 pounds.  Must possess the dexterity to utilize writing utensils (pen/pencil), calculators, small hand-held tools, manual razors, and other mechanical/electrical equipment without assistance.  Ability to work in close proximity to fellow teammates in cramped conditions.

Vision Requirements:

Visual acuity necessary to do the job safely and effectively. 

Specific vision abilities required by this job include close vision using a microscope and light source.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The area that this job is performed in is a general office or open cubicle/workstation environment.  The noise level in the work environment is usually moderate.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.