Sterilization Process Technician II (Monday - Friday, 6:00 am - 2:30 pm)

On-X Life Technologies, Inc.; Austin (TX); On-site; USD 30,000 - 50,000; Full time

Job summary

A leading company in the medical device industry is seeking a Final Packaging Technician II for their Austin facility. You will play a crucial role in ensuring the quality and compliance of heart valve devices by performing assembly operations, inspections, and documentation. This position requires a keen eye for detail and a commitment to maintaining high standards of quality in a fast-paced environment. Ideal candidates will possess a high school diploma, relevant experience, and strong communication skills.

Qualifications

• Understanding of FDA & ISO manufacturing practices.
• Adaptability to changes in product style and tools.
• Demonstrated knowledge of Final Packaging processes.

Responsibilities

• Perform as a subject matter expert within the Final Packaging area.
• Document and label products for final packaging requirements.
• Assist with scheduling and production activities to ensure on-time completion.

Skills

Attention to Detail

Manual Dexterity

Interpersonal Skills

Communication Skills

Education

High school diploma or equivalent

Associate degree or two years related work experience

Tools

Microsoft Office

Job description

Description

Company Overview

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. specializes in developing innovative medical devices aimed at addressing challenging cardiac and vascular conditions. Our Austin facility houses a diverse team dedicated to producing the On-X Mechanical Heart Valves. With over 1,600 employees globally and manufacturing sites in Atlanta, Austin, and Hechingen, Germany, Artivion serves healthcare professionals in over 100 countries. For more details on the On-X Mechanical Heart Valve, click here.

Position Objective:

A Final Packaging Technician II performs repetitive workstation assembly operations to mass produce the final package configuration for heart valve devices and other components. This individual visually inspects, sterilizes, tests, packages, and labels products for final packaging requirements to written specification. This position will assist with scheduling and maintaining day-to-day production to ensure on time completion. This position will be a subject matter expert within the Final Packaging area.

Responsibilities:

• Perform as a subject matter expert (SME) within the Final Packaging area. Emphasis may be in packaging, sterilization, or both.


• Originate documentation and print Final Packaging labels for product processing and traceability.


• Operate the following types of equipment per written procedures:
  
  
  
  • Level 1 sterilization / autoclave equipment
  
  
  • DYMO LabelWriter printer
  
  
  • Thermal, laser, and tracker feed printers
  
  
  • Automated Label Inspection System
  
  
  • Pressure Recorder System
  
  
  • Heat shrink oven
  
  
  • Pouch sealer
  
  
  • Peel test equipment
  
  
  • Sterilization Calibration Equipment
  
  
  
  


• Understand and adhere to line clearance practices by maintaining product identification and traceability.


• Monitor and document sterilization results via data output for parametric release.


• Submit test samples to lab in timely manner and monitor for approvals.


• Assist with scheduling and maintaining day-to-day production activities to ensure on time completion.


• Assist with training of personnel.


• Ability to troubleshoot equipment problems as needed.


• Assist Quality and Engineering with resolution to process problems.


• Keep work area and equipment in clean and orderly condition.


• Observe safety practices concerning self and others.


• Identify and recommend changes to solve problems that appear in the daily processes.


• Exposure to clean room or shop environment such as cooler temperatures, noise, dust, odors, etc.

Other responsibilities as assigned.

Qualifications:

• High school diploma or equivalent


• Associated degree or two years related work experience (manufacturing and/or medical device industry) required


• Experience in inspection or assembly or similar intricate hand work preferred


• Understand FDA & ISO manufacturing practices.


• Easily adapt to changes in product style, tools, and work environment


• Maintain quality emphasis and high attention to detail


• Good manual dexterity for handling small parts


• Basic computer skills including the following at minimum: Microsoft Office, internet, and electronic mail


• Strong interpersonal and communication skills


• Demonstrated SME level knowledge of Final Packaging processes


• Must be available to work Monday - Friday, 5:00 am - 2:30 pm

Equal Employment Opportunity Employer (EEO):
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status under applicable law.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.