Sterilization Process Technician

Enovis Corp; Austin (TX); On-site; USD 45,000 - 75,000; Full time

Job summary

Join a forward-thinking company as a Sterilization Process Technician, where you'll play a vital role in transforming patient care through innovative sterilization processes. This position offers the chance to work in a dynamic manufacturing environment, ensuring the highest standards of quality and efficiency in medical technology. Collaborate with engineering teams, manage sterilization loads, and contribute to continuous improvement initiatives. If you're passionate about making a difference in patients' lives and thrive in a fast-paced setting, this opportunity is perfect for you!

Qualifications

• 2-4 years of relevant manufacturing experience in med-device.
• Knowledge of good documentation processes and regulated businesses.

Responsibilities

• Manage and maintain sterility processes for medical implants.
• Conduct sterilization load quality checks and monitor incubator conditions.

Skills

Sterilization Processes

Problem Solving

Attention to Detail

Team Collaboration

Lean Manufacturing

Education

High School Diploma

Technical Degree or Certificate

Tools

Incubator Monitoring Equipment

Sterilizers

Water Quality Monitoring Systems

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:

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.

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 experience.
• 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:

• Continuously Seeks Improvement.
• Creativity and Innovative.
• Problem Solving.
• Team Player.
• Analytical and Logical Thinking.
• Attention to Detail.

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).