Senior Sterilization Engineer I

Date: Aug 3, 2022

Location: Pendleton, SC, US, 29670

Company: Arthrex

Requisition ID: 53936 
Title: Engineer Sr I - Sterilization 
Division: Arthrex Manufacturing Inc (US02) 
Location: Pendleton, SC 

 

 

 

 

 

 

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Sterilization Engineer I. This is an exciting opportunity to make your mark on a growing organization. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

Main Objective:

Maintain Arthrex Manufacturing sterilization processes in accordance with Quality Systems Requirements.

 

Essential Duties and Responsibilities:

  • Become proficient in the use and diagnostics of Arthrex’s ethylene oxide and/or radiation sterilization equipment
  • Manage and maintain Arthrex Manufacturing ethylene oxide sterilization cycles and/or radiation sterilization processes in compliance with appropriate regulatory standards
  • Perform sterilization cycle evaluations and validations in conjunction with the Sterilization Science and Biological Safety Team
    • Supports or performs equipment qualifications and computer system validation, where required.
  • Perform audits of Arthrex Manufacturing suppliers, contract laboratories, and critical process suppliers when necessary.
  • Act as front room and/or back room representative during audits by internal teams and notified bodies.
  • Ensure proper maintenance of Arthrex Manufacturing files demonstrating vendor compliance and performance including authoring and/or reviewing sterilization validations and product adoptions into existing cycles in conjunction with the SSBS Team.
  • Recognize and address sterilization processing issues
  • Evaluate, author and optimize sterilization procedures including employee training
  • Support the “certified operator” and/or radiation safety programs.
  • Provide EH&S with timely communication on safety training and environmental compliance.
  • Track and trend sterilization non-conformances and processing metrics
  • Facilitate resolution of sterilization related, CAPAs. non-conformances, and audit findings.
  • Provide assistance in assessing device design for ethylene oxide sterilization and radiation sterilization methods when necessary.
  • Encourage a continuous process improvements environment
  • Support Arthrex business and expansion goals
  • Provides feedback and recommendations to management on initiative performance, goals and status.

 

 

Skills:

  • Knowledgeable of FDA and ISO guidelines for the sterilization validation of medical devices required.
  • Manufacturing process knowledge preferred.
  • Project management and communication skills training preferred.
  • Working knowledge of terminal sterilization methods required.
  • Hands on experience performing laboratory testing activities.
  • Test protocol and report writing experience preferred.
  • Working knowledge of device clinical use and associated harms and hazards
  • Knowledge of orthopedic surgery principles, theories, and products preferred.

 

Education/Experience:

  • 5 Years with BS Degree in biology/microbiology, chemistry, engineering or engineering technology.
  • Experience with E-beam/X-ray or Gamma radiation modalities preferred
  • Certified Industrial Sterilization Specialist (CISS-R, CISS-EO) preferred

 

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

Specialized training manufacturing operations, system design and development, industrial statistics, and technical writing preferred. Experience in working with sterilization standards (specifically, ISO 11135 and ISO 11137)

 

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company). Experience with Minitab, Power BI, and SAP or corporate ERP systems preferred.

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.


Nearest Major Market: Greenville
Nearest Secondary Market: South Carolina

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