Engineer II - Sterilization

Arthrex-posted 3 months ago
Entry Level
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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 Sterilization Engineer II. This is an exciting opportunity to make your mark on a growing organization. Successful candidates will possess a minimum of a bachelor’s degree and must maintain Arthrex Manufacturing sterilization process in accordance with Quality Systems Requirements. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

  • Become proficient in the use and diagnostics of Arthrex’s ethylene oxide sterilization equipment
  • Manage and maintain Arthrex Manufacturing ethylene oxide sterilization cycles
  • Manage and maintain Arthrex sterilization compliance with appropriate regulatory standards
  • Perform sterilization cycle evaluations and validations in conjunction with the Sterilization Science and Biological Safety Team
  • Perform audits of Arthrex Manufacturing suppliers, contract laboratories, and critical process suppliers when necessary
  • 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 and optimize sterilization procedures including employee training
  • Implement and manage the 'certified operator' training program
  • 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 MRB’s, non-conformances, and audit findings
  • Provide assistance in assessing device design for ethylene oxide sterilization method when necessary
  • Encourage a continuous process improvements environment
  • Support Arthrex business and expansion goals
  • Bachelor’s degree in industrial science, engineering, or related science field required
  • 2 years’ experience in sterilization, validation, medical device quality assurance, or related field required
  • Specialized training manufacturing operations, system design and development, industrial statistics, and technical writing preferred
  • Medical, Dental and Vision Insurance
  • Company-Provided Life Insurance
  • Voluntary Life Insurance
  • Flexible Spending Account (FSA)
  • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
  • Matching 401(k) Retirement Plan
  • Annual Bonus
  • Wellness Incentive Program
  • Free Onsite Medical Clinics
  • Free Onsite Lunch
  • Tuition Reimbursement Program
  • Trip of a Lifetime
  • Paid Parental Leave
  • Paid Time Off
  • Volunteer PTO
  • Employee Assistance Provider (EAP)
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