Sterilization Manager

Help lead the effort to create global strategies for worldwide medical device approvals to introduce new   products to market.

In this exciting role as a Microbiologist–Sterilization Manager you will be a key member of Medtronic’s Sterilization Services Team.   Impact patient outcomes.  Come for a job, stay for a career.

RTG

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

Within RTG, the SPINE division shapes spine surgery for the better; delivering procedural solutions and therapeutic biologics and partnering with other healthcare stakeholders to accelerate innovations that can improve surgical efficiencies and help create better outcomes for more patients.

As the Microbiologist–Sterilization Manager you will lead the Sterilization Services Team and work closely with cross-functional teams to manage and execute sterilization activities for new product introductions (NPI),  Released Product Management (RPM) and sustaining sterilization projects.

Responsibilities may include the following and other duties may be assigned.

• Analyzes chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company's quality program.
• Prepares, cleans, disinfects, and/or sterilizes instruments, materials, products, and/or supplies.
• Follows protocols and regulations in order to clean, store, and/or deliver products, supplies, and/or instruments.
• Interprets and evaluates the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary.
• Develops, validates, and implements controlled environment methods.
• Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devises and develops new analytical methods and techniques.
• Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.
• May also be involved in establishing requirements for the transfer of methodology from R&D.

• Create proper work flow and manage/prioritize projects based on business needs. 
• Provide technical solutions to research and development and manufacturing organizations using microbiological/sterilization theory and practice, i.e. Radiation, Ethylene Oxide and Steam Sterilization and Reprocessing Methodologies.
• Work with contract sterilizers to maintain sterilization validations using either Moist Heat, Radiation or Ethylene Oxide Sterilization in accordance with all industry, national and international guidance regulations.
• Interact with Regulatory, Quality, Packaging and R&D Engineering to maintain microbiological specifications and test plans necessary to ensure compliance with the overall Quality Requirements.
• Interact with Purchasing and Contract Sterilization/Test Facilities to ensure the Sterilization requirements and product testing procedures are clear, complete and understood.
• Knowledge in compendial (AAMI, USP, ISO) methodologies and techniques.  Ability to read and interpret documents related to medical device sterilization and cleanrooms, including: national and international standards, regulations, technical procedures, journals, regulatory publications.
• Expertise in cGMP’s and quality systems as related to aseptically manufactured and terminally sterilized medical devices.
• Advanced knowledge of microbiology principles, methods and procedures, including knowledge of bacteria morphology and staining, aseptic technique specifically as they relate to sterilization methods.
• Environmental Monitoring (EM) and controlled environment subject matter expertise.