Requisition ID: 47500 Title: Engineer Tech - Packaging Division: Arthrex Manufacturing Inc (US02) Location: Pendleton, SC
This position will be located at the new Arthrex manufacturing facility in Pendleton, SC.
Responsible for supporting Packaging Operations and Packaging and Manufacturing Engineers with the development and execution of final assembly, process, and packaging equipment validations. 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 the drafting and execution of Arthrex packaging validation protocols (DOE/IOQ/PQ) for the following processes: pouch sealing, blister sealing, burst testing, pull testing, dye penetration testing, labeling, boxing, label printing, laser marking, RFID/HID/barcode scanning, manual and automated assembly processes, special assembly fixtures and tools, etc.
- Supports new product development by assisting with Packaging Design validations and engineering.
- Devises packaging sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
- Supports Packaging and Process Engineers in drafting and executing validation protocols and reports.
- Supports Packaging and Process Engineers in drafting work instructions.
- Supports Packaging and Process Engineers with managing new tools and fixtures. Contact vendors, as needed to ensure equipment is in optimal condition for production use.
- Ensures changes to tools and fixtures are properly documented prior to change and/or validation activities.
- Responsible for tools and fixtures: Supports Production in the control, repair tracking, and inventory of tools and fixtures. Requests quotes as needed for new tool/fixtures and/or for repairs.
- Responsible for coordinating calibration of process equipment and test apparatus.
- Coordinates packaging process changes and new product and/or packaging introductions into clean rooms, controlled environments, and material handling/boxing support areas.
- Maintains precise identification and control of validation samples and ensures information and documentation is consistently accurate.
- Maintains currency with ISO/FDA and internal quality assurance policies.
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.
- A Bachelor degree in engineering field preferred.
- Experience as a Packaging or Process Engineering Assistant or Technician is required.
- Understanding of PLC/Controls testing and validation documentation is desired.
- Experience with Medical Device Packaging is preferred.
- PC skills such as Windows, Microsoft office is required.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Knowledge of medical packaging materials and processes, statistical methods, control plans, BOMs/Routers, and ability to read blueprints required. Design of Experiments and FMEA working knowledge required.
Machine, Tools, and/or Equipment Skills:
Pouch and blister tray sealing equipment, package testing equipment, dye penetration testing, label printing equipment; laser equipments, automated equipments, proficiency in the use of personal computers and programs, particularly Microsoft Office; exposure to QAD, Oracle EBS or similar MES software; Experience with AutoCAD, Solid Works or ProE software desirable.
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.
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 required.
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.
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.
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.
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.
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