Sr. Sterilization Engineer 1

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.
• Implement and manage the “certified operator” training program or support existing 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 MRBs CAPAs, non-conformances, and audit findings.
• Provide assistance in assessing device design for ethylene oxide sterilization and radiational sterilization methods when necessary.
• Encourage a continuous process improvements environment
• Support Arthrex business and expansion goals

Education and Experience:

• BS Degree in biology/microbiology, chemistry, or related science field required
• 5 years of relevant experience required.
  • Experience with Ethylene Oxide exposure and/or 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)
• Provides feedback and recommendations to management on initiative performance, goals and status.
• Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts and principles.
• 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 preferred.
• Hands on experience performing laboratory testing activities preferred.
• 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.

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 CAD software (e.g. Solidworks), Minitab, and corporate ERP systems preferred.

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.

Develops solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

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 sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds. To occasionally lift up to 10 lbs on a regular basis.

Vision Requirements:

Visual acuity necessary to do the job safely and effectively.

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.

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.

Arthrex 2024 Benefits

• 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)

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.