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Microbiologist-Sterilization Manager

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Research & Development
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19000G8R Requisition #

Careers That Change Lives

 

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  BRAIN THERAPIES offers an integrated portfolio of devices
and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.

 

A Day in the Life

 

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.

  • 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. Dry heat, and Ethylene Oxide   Sterilization and Reprocessing Methodologies.
  • Work with contract sterilizers to maintain sterilization validations using either Dry heat 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. 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.

Must Have: Minimum Requirements

To be considered for this role, the minimum requirements must be evident on your resume. 

  • Bachelor’s degree in Biological Science, Biomedical Engineering, Chemistry or related field with a minimum of 5 years of experience in sterilization, or microbiology/clean room technology or advanced degree with a minimum of 3 years of experience (as listed above) 
  • Supervisory/leadership experience (e.g., supervising/managing people/teams and projects/programs) 

Nice to Have: Preferred Requirements

  • Experience at Medtronic or within a medical device industry.
  • 5+ years of supervisory/leadership experience managing a team.
  • 2+ years of Program Management in sterilization, manufacturing operations or other relevant area.
  • PMP certification; Project Management Certification (preferably PMI) and/or Green Belt Certification
  • Proficient with MS Program, Excel, Word, PowerPoint, Project (or similar scheduling software), project management techniques and tools.
  • Excellent project management skills, organization and communication skills.


About Medtronic


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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