ASO CORPORATION



GENERAL SUMMARY:

The Industrial Engineer at ASO is responsible for designing and implementing processes and workflows to maximize efficiency and maintain quality. Implementation will include utilization of existing equipment as well as scoping and specifying new technology to handle the increased scales of manufacturing. Technologies at ASO include adhesive coating, web converting as well as automated packaging processes.

Functional Responsibilities:

• Conduct time studies and identify potential Cost Reduction efforts. May assist in the coordination and implementation of recommended improvements. Assist in Cost Performance analysis and Process Plan implementation.

• Evaluate and enhance operational processes for consistency and efficiency between different production sites to align efforts and initiatives to organization goals.

• Lead process control, calibration, implementation and operation of automation systems in an ISO 13485 GMP environment.

• Lead operations team (ie. Manufacturing, Maintenance, Quality, Planning etc.) in PMT (Performance management team) support, and identification of process improvements.

• Conduct new and upgraded process Implementation. Implementation will include working with quality to validate the equipment and performance.

• Responsible for validation protocol and execution (IQ, OQ, PQ), test method definition, root cause analysis, gage R&R, and measurement systems analysis (MSA), CpK, capacity planning, FMEA, Kaizen studies and hands-on troubleshooting

• Analyze machinery, equipment, layouts and manufacturing processes to increase efficiency, safety, quality and reduction of operating costs, product/process flow throughout various operations and design processes

• Write and conduct computer simulations and other analysis of the manufacturing process to ensure proper machine utilization, line balancing, operations sequencing, materials handling, etc...

• Gather and analyze Overall Equipment Efficiency (OEE) including rate, yield and utilization to facilitate decision-making and performance trending

• Lead and manage Continuous Improvement Team (CIT). Support and facilitate continuous improvement within the Value Streams. Examine existing Converting/Packaging process for cost savings opportunities. Interface with all departments to execute continuous improvement initiatives.

• Apply statistical methods for (SPC) Statistical process control, including CpK analysis to estimate future manufacturing requirements and potential defects

Operations Performance Management:

• Establish clear measurable goals and objectives for improvements to determine individual and team results (i.e., 5S initiatives on various processes, Material and personnel flows, results against project timelines, training documentation, and personnel development goals)

• Solicit ongoing feedback from fellow team members, superiors, and other departments. Provide ongoing coaching and counseling to team members based on the feedback.

• Drive individuals and the team to continuously improve in key operational metrics and the achievement of the organizational goals.

• Coordinate activities of large teams and keep them focused in times of crises.

• Ensure recognition and rewards are managed fairly and consistently in area of responsibility.

Cost Management:

• Detailed analysis of costs of present and proposed methods for all processes, including changes in methods, policies, manpower, machines, equipment and layout

• The role will be responsible for cost analysis and optimization to ensure efficient operations

• Develop or direct the development of labor cost standards and estimates

• Participate in ROI evaluations for continuous improvement projects and new product/process developments.

Job Requirements:

• BS in Industrial Engineering, mechanical engineering or related Engineering field required

• ISO 13485 or other cGMP knowledge, Working knowledge of FDA requirements as per 21 CFR 820 preferred, PMP a plus.

• 3+ years’ experience in related field preferred

• Must possess excellent application problem-solving and communication skills

• Must be knowledgeable of manufacturing processes in high quantity production rate

• Must be proficient in the use of MS Word & Excel, Minitab, AutoCAD and Inventor

• All employees have the responsibility and authority to report any action that puts any process or product at risk.

• Travel required 30% - 50% of the time

• Other duties as assigned.

Health, Safety & Environmental Considerations/Requirements:

Must be able to carry out all of the essential functions of the position in a safe and responsible manner including taking precautionary measures to protect his or her own safety and health, the safety and health of others in addition to protecting the environment. Always uses and maintains appropriate personal protective equipment (PPE) - protective clothing, equipment, and other health and safety facilities provided for the protection of his or her health and the safety of others. Reports immediately to his or her supervisor any situation, which he or she believes, presents a risk to his or her health or safety or that of any other person and or that of the environment. Abides by and cooperates with management, employees and others to ensure compliance with Health, Safety, and Environmental policies and procedures. Conducts inspections of health, safety and environmental conditions and risks in his or her working area as required, corrects sub-standard items/conditions/risks and/or reports these to his or her supervisor as appropriate. Asks questions and/or informs his or her supervisor when unsure about any health, safety or environment condition, policy or procedure.

Everyone has the responsibility and is empowered to take personal leadership to:

▪ Ensure personal compliance to meet all EHS standards

▪ Take immediate action to correct any substandard condition or behaviors

▪ Ensure work areas and equipment are in safe condition.

▪ Ensure that every task/job performed is done safely and with no adverse health consequences.

▪ Identify, assess, control and report hazards using Field Level Risk Assessment.

▪ Safeguard and watch out for co-workers.

▪ Identify new workers and help coach them to learn proper work activities.

▪ Follow established procedures.

▪ Identify and communicate situations where procedures are not adequate or do not exist.

▪ Ask for help if skills, physical capabilities and/or knowledge are not adequate to do the tasks.

▪ Refuse work deemed unsafe and report to your supervisor.

 

STOP and THINK

▪ Stop frequently to analyze.

▪ Think continuously to anticipate and especially every time something changes.

IDENTIFY THE HAZARD

▪ Ask what could go wrong and anticipate all the possibilities.

ASSESS THE RISKS

▪ Ask how bad it could be

▪ Ask could I be hurt?

▪ Ask could others be hurt?

CONTROL THE RISKS

▪ Ask what I could do about it

▪ Take action by changing position, method or get help

▪ Report it to my supervisor

RESUME WORK

Job Description Acknowledgement

ASO LLC and all affiliated companies (“ASO”) continuously reviews its job descriptions in an effort to

keep employees informed of their overall job responsibilities. However, your job description is not all inclusive. You may be asked to carry out job responsibilities and/or functions that are not noted on the job description.

The receipt of a job description is not intended to create a contract for a specific term of employment and/or any other legally enforceable promise, and that continued employment with ASO or all Affiliated companies (“ASO”) is at will.

By signing each page, the signature of the employee acknowledges the receipt of this job description.

By signing each page, the signature of the manager acknowledged reviewing the job description with the employee.

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