Sterility Technician 3

Job Description:

At Enovis we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it.

Because that's how we change the lives of patients for the better. And that's how we create better together.

As a key member of the Sustaining Manufacturing Engineering group, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

Job Title:

Sterilization Process Technician - Gas Plasma and Vapor Hydrogen Peroxide Processes

Reports To:

OPS Manager / Director

Location:

Austin Texas

Business Unit Description:

Driven by Enovis' desire to create innovative products that help improve quality of life and restore movement to those suffering from degenerative arthritis, Enovis Surgical provides orthopedic surgeons with modern, patient-focused solutions for total joint arthroplasty. Partnerships with key surgeon consultants help provide advanced and proprietary patented solutions, including EMPOWR 3D Knee, the only dual-pivot knee system on the market, and AltiVate Reverse Shoulder, a market-leading system, based on the design principles of the RSP Shoulder, which has demonstrated excellent clinical outcomes at 10 years. Enovis Surgical offers surgeons and their patients a full range of primary and revision implants for hip, knee, shoulder, and elbow reconstructive joint surgeries, in addition to the tools and digital health technology needed in today's changing healthcare environment.

Job Title/High Level Position Summary:

As an Enovis Sterilization Process Technician, you will take ownership of managing and maintaining assigned sterility processes to support plant strategic goals of the equipment and production needs. You will continuously drive to keep assigned sterilization processes current and efficient as well as to adhere to all strict process procedures and guidelines.

Key Responsibilities:

• Sterilization of Medical Implants: Sterility Lot Number Assignment; SCBI and PCD Preparation / Placement; Sterilization Load Preparation; Sterilization Cycle Selection; Temperature Load Probe Placement; Conduct Sterilization Load Quality Checks; Conduct Pre-Cycle Machine and Input Utility Checks; Monitor Informative and Aborting Alarms during cycle; Collaborate with Process Engineering and Maintenance to act on in-cycle alarms; Perform Unloading Operation and transfer processed product to Sterility Quarantine
• Biological Indicators (SCBIs): Conduct SCBI Inspection; Manage SCBI Shelf Life/ Expiry; Manage SCBI Stock and Ordering; Conduct SCBI Test with Controls; Evaluate Results for Sterility Release
• Incubator Monitoring: Monitor Incubator Conditions and data collection instrumentation; Collaborate with Process Engineering to make Incubator set point adjustments as needed; Clean and maintain incubator; Understand and communicate calibration due dates
• Hydrogen Peroxide: Conduct Hydrogen Peroxide Consumable Inspection; Manage Safe Storage and Shelf Life/Expiry of Hydrogen Peroxide; Manage Expiry of "Opened" Peroxide loaded into Sterilizer Machine; Manage Hydrogen Peroxide Stock and Ordering
• Sterilizer Maintenance (TPM): Perform Daily Checks, Cleaning, and minor maintenance of Sterilizers; Perform Weekly PMs in collaboration with Maintenance; Perform Warm-up Cycles as needed; Perform Chamber Leak Rate Tests as needed; Perform Filter Sterilization Cycles as needed
• Sterilization Process Monitoring: Work with Sterilization Process Engineer to collect and record sterilization process data; Escalate process abnormalities and issues to Maintenance and Process Engineering; Executes Test Protocols Issued by Process Engineering; Manage Life Cycle of Sterilization Dunnage packages
• Requalification: Understand Annual Sterilization Requalification Needs; Assist Process Engineering and Microbiology in requalification as needed
• Input Utility Monitoring:
  • Water System
    • Conduct Daily and Pre-Cycle Checks
    • Understand general water system functionality
    • Operate Water Sub-systems as needed
    • Understand needs for Water Quality Monitoring
  • Compressed Air
    • Conduct Daily and Pre-Cycle Checks
    • Understand needs for Air Quality monitoring
• Gamma Sterilization: Prepare and Package Implants for Gamma Sterilization per specific standards; Create Sterilization Manifest; Palletize Gamma Sterilization Shippers; Transfer Pallets to Shipping

Minimum Basic Qualifications:

• High School required, Technical Degree or Certificate a plus
• 2-4 years of relevant manufacturing
• Relevant knowledge in med-device manufacturing related to good documentation processes and general awareness of regulated businesses (IE: Med-Device; Aerospace; Automotive)
• Additional pluses: Lean Manufacturing/Kaizen Experience; Team Lead
• Must have a passion for working in a fast-paced 24/5 manufacturing environment and driving continuous improvement to processes and equipment.

Travel Requirements:

• The ability to travel, on occasion, as needed for training.

Desired Characteristics:

• Insatiable Curiosity
• Continuously Seeks Improvement
• Creativity and Innovative
• Problem Solving
• Soft Skills - Communication & Leadership
• Team Player
• Analytical and Logical Thinking
• Attention to Detail
• Embraces Change
• Optimistic

Physical Requirements:

• Ability to work in a manufacturing environment (Constant)
• Required to sit and/or stand for lengthy periods; talk, hear, and use hands and fingers to operate relevant needed equipment (Frequent)

"Creating better together". It's the Enovis purpose, and it's what drives us and empowers us every day on a global scale. We know that the power to create better - for our customers, our team members, and our shareholders - begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.

Watch this short video and discover what creating better together means to us at Enovis:

Our Enovis Purpose, Values and Behaviors on Vimeo

We offer a comprehensive benefits package which includes:

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Spending and Savings Accounts
• 401(k) Plan
• Vacation, Sick Leave, and Holidays
• Income Protection Plans
• Discounted Insurance Rates
• Legal Services

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. Visit www.enovis.com to learn more.

EQUAL EMPLOYMENT OPPORTUNITY:

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond.For more information about Enovis, please visit www.enovis.com.

EOE AA M/F/VET/Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.