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Sr Microbiologist-Sterilization Manager

Research & Development
19000BKB Requisition #
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Careers that Change Lives

In this exciting job you will manage and lead the Quality Microbiology department whose mission is to plan and execute operations compliance, project and product testing, test data management, and quality metrics and reporting at the Santa Ana manufacturing facility. 

The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.

CORONARY AND STRUCTURAL HEART provides interventional devices to treat coronary arteries that are blocked by atherosclerotic plaque and devices and therapies to treat structural defects of the heart.

A Day in the Life

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

  • Manage microbiology, sterilization and biocompatibility sterilization with the Santa Ana teams in the participation of projects including Operations, Supply Chain, Regulatory/Clinical, and R&D based initiatives.
  • Define the strategy and vision of the department, develop and implement improvement initiatives of environmental, microbiology, sterilization and biocompatibility areas for Santa Ana.
  • Lead and develop team to establish talent pool depth and breadth.  Develop effective succession plan.
  • Provides microbial technical expertise during new product development activities, process modification studies and failure investigations regarding microbiological contamination control. Serves as technical liaison with functional groups, contract laboratories and manufacturing sites.
  • Evaluates materials and products and recommends appropriate biocompatibility assessment to meet requirements of applicable standards and procedures.  Coordinates the biocompatibility testing of new products and materials.  Reviews ISO 10993 series standard changes for potential impact on existing test data and updates biocompatibility data and assessments, as appropriate.
  • Ensures compliance to Good Manufacturing Practices specific to Buildings, Environmental Control, Cleaning and Sanitation and Personnel Practices. Assures compliance with all applicable international and domestic regulations and standards by defining policies, monitoring environmental control and conducting necessary microbiology related training.
  • Administers the Environmental Monitoring Program for manufacturing areas, in order to provide the necessary information (e.g., viable and non-viable particulate counts, product bio-burden, water and surface microbial levels, etc.) to ensure an appropriately controlled environment meeting regulatory expectations and industry standards.
  • Conducts OOS (Out of Specification) investigations, establishes actions to address OOS and reviews output of OOS Investigations with Quality Management.
  • Communicates detailed information regarding required policies and monitoring results to Manufacturing and Quality Assurance Managers. Establishes trends; recommends revisions to monitoring program and/or manufacturing process controls. Ensures effective corrective actions are implemented, where necessary.
  • Provides microbiological technical expertise to the Facilities department regarding cleaning and contamination control.
  • Provides microbiological technical expertise to the Supplier Quality department in the selection and use of component vendors. Provides input into the change control process for changes to supplier processes, materials and manufacturing environments which may impact sterilization, microbiology and biocompatibility.
  • Assures timely, accurate and independent evaluation of product compliance to sterilization, microbiology and biocompatibility requirements.
  • Provides microbiological technical expertise and guidance in the support of microbiology lab management.  Leads the team in the department manager on performance, goals, and status.
  • Monitors day-to-day performance of personnel assigned to environmental monitoring tasks. Provides feedback and recommendations to department manager on performance, goals, and status.
  • Supports other business units and microbiology labs, and act as an expert and advisor to drive improvements and changes.
  • Supports Regulatory Affairs and other departments by providing technical input on sterilization, microbiology and biocompatibility related content of regulatory submissions and departmental procedures.
  • Functions as part of the site Quality Engineering team and supports other Quality System elements (such as CAPA or Nonconforming Material Reports) as needed. 
  • Travels with minimum advanced notice to perform responsibilities outlined in this job description.

Must Have: Minimum Requirements

Bachelor’s degree in Microbiology, Chemistry, Biological Science or other technical discipline with 7+ years of microbiology and/or chemistry and/or quality experience with 5+ years of program or people management  experience

OR Advanced degree in Microbiology, Chemistry, Biological Science or other technical discipline with 5+ years of microbiology and/or chemistry and/or quality experience with 5+ years of program or people management  experience

Nice to Have
  • Thorough familiarity with FDA, EU and other international regulations, standards and guidelines covering sterilization and microbial contamination control in the manufacture of sterile medical devices.
  • Solid understanding of different types of sterilization methods (EtO, gamma, steam, etc.) including processes and equipment.
  • Proven leadership and knowledge in international and national standards such as AAMI/ANSI standards, E-Beam, ISO 17665 (Steam), 14160 (Liquid), 11137 (Radiation), 11135 (EtO) and others as applicable (i.e. EN).
  • Proven management and interpersonal skills.
  • Excellent organizational and judgment skills.
  • Ability to maintain and generate accurate records.
  • Master’s degree in Microbiology or similar field.
  • Certified microbiologist or toxicologist.

  • Working knowledge of statistical techniques.

  • Experience in biocompatibility testing.

  • Strong written, verbal 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)  

Up to 10% travel

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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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