Engineer - Packaging

This position will be located at our new manufacturing facility in Sandy Springs, SC.

Main Objective:

Responsible for supporting Packaging Operations and Packaging and Manufacturing Process Engineers on the development and execution of sterile packaging processes including material, design, and equipment validations. 

Essential Duties and Responsibilities:

• Assist in the selection, installation, and validation of medical device packaging equipment.
• Write and execute engineering studies/DOEs, validation IOQ/PQ protocols, gage R&Rs for packaging equipment processes, tools/fixtures, and inspection apparatus including:  pouch sealing, blister tray sealing, burst testing, pull testing, dye penetration testing, print & apply, etc. 
• Design, validate, and maintain packaging tools, gaskets, and fixtures including documentation and revision control.
• Introduce new packaging equipment processes utilizing project management tools, Risk Analysis/PFMEA, and Lean Manufacturing techniques.
• Conduct and document package dynamics and unit package testing for process and design validations.
• Identify cost saving opportunities.  Lead/support packaging process improvement initiatives.
• Support Engineering Change Management and maintain routers, Bills of Materials, work instructions, and process setup forms including deviations and temporary routers.   
• Provide operator training.
• Analyze and plan workforce utilization using time studies.  Determine space requirements and workflow/floor layouts for maximum efficiency.  Develop project proposals including cost justifications for management.
• Participate in defining Preventive Maintenance programs for clean room equipment/ and or production equipment associated with packaging or production activities.
• Coordinate packaging process changes and new packaging introductions into clean rooms, controlled environments, and material handling/boxing support areas.
• Stay current with methods used in the medical device industry to advance technologies. 
• Stay current with ASTM/ISO/FDA and internal quality assurance policies.
• Support programs, policies, and procedures in order to help the growth of AMI as a world class medical device manufacturer.

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:

• Bachelor’s degree in engineering required, preferably Packaging Engineering, Industrial Engineering, or Industrial Technology.
• Previous Packaging or Process Engineering experience preferred.
• Medical device or regulated industry experience preferred.
• Strong technical writing skills required.
• Proficient in Microsoft Office Suite (Word, Excel, Project, Outlook).
• Minitab, Solidworks or AutoCAD experience preferred.

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 preferred. 

Machine, Tools, and/or Equipment Skills:

Pouch and blister tray sealing equipment, package testing equipment (burst, dye penetration, bubble emission, O2 Analyzer, shock/vibration, etc.) preferred; exposure to SAP desirable.

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 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.

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.