Sr. Microbiologist-Sterilization

Irvine, California, US
Jun 04, 2021
Jun 21, 2021
Employment Type
Full time
Salary Type
Careers That Change Lives

A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

In this exciting role as a Sr. Microbiologist-Sterilization you will have responsibility for supporting on market product sterilization validations. You will have responsibility for all sustaining sterilization work and to support of changes to existing products and introduction of new products. These validations include product sterilization validations, along with product and process validations. The position provides technical solution to achieve validated sterilization processes for new and existing products. Updates to routine sterilization procedures and related specifications. Supports and leads team with assessments of new products or changes to existing products. Support and lead team with sterilization validation activities related to changes to new cleanrooms and capacity expansion projects.

A Day in the Life

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.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

Bachelor's degree in Science or technical field with 4+ years of work experience in microbiology, sterilization, and/or biocompatibility experience OR Advanced degree in science or technical field with 2+ years of work experience in microbiology, sterilization, and/or biocompatibility experience.

Nice to Have
  • Certified Industrial Sterilization Specialist (CISS)
  • Experience in Ethylene Oxide Sterilization validation
  • Thorough knowledge of fundamental microbiology principles, methods and procedures, including knowledge of bacteria morphology and staining, aseptic technique specifically as they relate to sterilization methods.
  • Environmental Monitoring (EM) subject matter expertise.
  • Expertise in clean room requirements and gowning requirements
  • Ability to multi-task, Skilled in planning, organizing, coordinating projects and working independently.
  • Ability to write protocols, reports, procedures and work instructions
  • Ability to read and interpret documents related to medical device sterilization and cleanrooms Including:
    International standards, regulations, technical procedures, journals, regulatory publications. Familiarity with FDA regulations.
  • Working knowledge of MS Word, Excel, PowerPoint, MS Outlook, Project
  • Expertise in cGMP's and quality systems as related to terminally sterilized medical devices.
  • Knowledge in compendial (AAMI, USP, ISO) methodologies and techniques.

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)