Microbiologist Sterilization Manager
Medtronic
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Job summary
Medtronic seeks a Microbiologist Sterilization Manager to lead microbiology and sterility programs across manufacturing sites in the US, ensuring regulatory compliance and quality performance. You will develop and mentor engineers and scientists, drive CAPA initiatives, and collaborate with Quality, Operations, Engineering, and R&D to safeguard patient safety and product quality.
The role requires onsite presence at least four days per week with up to 25% travel, and offers broad
Qualifications
- Bachelor’s degree with 5+ years in microbiology/sterilization/biocompatibility.
- Advanced degree with 3+ years in microbiology/sterilization/biocompatibility.
- Minimum 2 years supervising or managing others.
Responsibilities
- Lead microbiology and sterility assurance programs across sites.
- Provide leadership for engineers and scientists in microbiology, environmental monitoring, sterilization, contamination control.
- Serve as site/regional SME for microbiology and sterilization and guide technical/compliance issues.
- Oversee development, execution, and maintenance of microbiology, sterilization, environmental monitoring, and controlled environment programs.
- Lead investigations and CAPA in microbiology quality and sterility assurance.
- Monitor KPIs and quality metrics to support compliance and operational excellence.
- Support product introductions, process transfers, and validation with microbiology/sterilization requirements.
- Represent microbiology/sterility in internal audits, regulatory inspections, and external assessments.
Skills
Education
Job description
Medtronic is a global healthcare technology leader focused on solving some of the most complex health challenges worldwide. The company develops innovative medical technologies and therapies that aim to alleviate pain, restore health, and extend life. Medtronic works across a broad range of clinical areas, partnering with healthcare professionals to improve patient outcomes. Team members are part of a mission-driven organization that combines cutting-edge science with a strong commitment to transforming lives.
The Microbiologist Sterilization Manager is part of the Global Operations & Supply Chain organization and provides microbiology and sterility assurance leadership for manufacturing sites within the Central Region. The team partners closely with Quality, Operations, Engineering, and Research & Development to ensure microbiological quality, regulatory compliance, and effective implementation of sterilization and contamination control programs across multiple facilities.
The position may be based in Fort Worth, TX; Memphis, TN; Warsaw, IN; or Milwaukee, WI. This position requires onsite presence a minimum of four (4) days per week. The role also requires up to 25% domestic travel.
This role provides technical and people leadership for microbiology and sterility assurance activities supporting medical device manufacturing operations. The position is responsible for ensuring compliance with microbiological and sterilization requirements, leading continuous improvement initiatives, supporting regulatory inspections and audits, and developing a high-performing team focused on product quality and patient safety.
- Lead microbiology and sterility assurance programs that support manufacturing operations and regulatory compliance across assigned sites.
- Provide leadership and development for engineers and scientists responsible for microbiological testing, environmental monitoring, sterilization, and contamination control activities.
- Serve as the site and regional subject matter expert for microbiology and sterilization and provide guidance on technical and compliance-related issues.
- Oversee the development, execution, and maintenance of microbiology, sterilization, environmental monitoring, and controlled environment programs.
- Lead investigations, corrective and preventive action (CAPA) activities, and continuous improvement initiatives related to microbiological quality and sterility assurance.
- Monitor, analyze, and report key performance indicators and quality metrics to support operational excellence and compliance objectives.
- Support new product introductions, process transfers, and validation activities by establishing microbiology and sterilization requirements for manufacturing implementation.
- Represent microbiology and sterility assurance functions during internal audits, regulatory inspections, and external assessments.
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
- Bachelor’s degree in science or technical field with 5+ years of work experience in microbiology, sterilization, and/or biocompatibility experience OR Advanced Degree in Science or technical field with 3+ years of work experience in microbiology, sterilization, and/or biocompatibility experience.
- Requires a minimum of 2 years of prior experience supervising or managing others.
- Experience in the front room of FDA inspections or notified body audits.
- Experience serving as a subject matter expert during audits, inspections, or regulatory assessments.
- Demonstrated understanding of the industrial sterilization business and contract sterilizer operations.
- Experience supporting microbiology and sterilization programs within a regulated manufacturing environment.
- Experience with controlled environment monitoring, process water systems, and/or industrial sterilization processes such as Ethylene Oxide (EO), Vaporized Hydrogen Peroxide (VHP), Moist Heat, Dry Heat, or Radiation sterilization.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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.
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Medtronic is a global healthcare technology leader focused on solving some of the most complex health challenges worldwide. The company develops innovative medical technologies and therapies that aim to alleviate pain, restore health, and extend life. Medtronic works across a broad range of clinical areas, partnering with healthcare professionals to improve patient outcomes. Team members are part of a mission-driven organization that combines cutting-edge science with a strong commitment to transforming lives.
The Microbiologist Sterilization Manager is part of the Global Operations & Supply Chain organization and provides microbiology and sterility assurance leadership for manufacturing sites within the Central Region. The team partners closely with Quality, Operations, Engineering, and Research & Development to ensure microbiological quality, regulatory compliance, and effective implementation of sterilization and contamination control programs across multiple facilities.
The position may be based in Fort Worth, TX; Memphis, TN; Warsaw, IN; or Milwaukee, WI. This position requires onsite presence a minimum of four (4) days per week. The role also requires up to 25% domestic travel.
This role provides technical and people leadership for microbiology and sterility assurance activities supporting medical device manufacturing operations. The position is responsible for ensuring compliance with microbiological and sterilization requirements, leading continuous improvement initiatives, supporting regulatory inspections and audits, and developing a high-performing team focused on product quality and patient safety.
- Lead microbiology and sterility assurance programs that support manufacturing operations and regulatory compliance across assigned sites.
- Provide leadership and development for engineers and scientists responsible for microbiological testing, environmental monitoring, sterilization, and contamination control activities.
- Serve as the site and regional subject matter expert for microbiology and sterilization and provide guidance on technical and compliance-related issues.
- Oversee the development, execution, and maintenance of microbiology, sterilization, environmental monitoring, and controlled environment programs.
- Lead investigations, corrective and preventive action (CAPA) activities, and continuous improvement initiatives related to microbiological quality and sterility assurance.
- Monitor, analyze, and report key performance indicators and quality metrics to support operational excellence and compliance objectives.
- Support new product introductions, process transfers, and validation activities by establishing microbiology and sterilization requirements for manufacturing implementation.
- Represent microbiology and sterility assurance functions during internal audits, regulatory inspections, and external assessments.
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
- Bachelor’s degree in science or technical field with 5+ years of work experience in microbiology, sterilization, and/or biocompatibility experience OR Advanced Degree in Science or technical field with 3+ years of work experience in microbiology, sterilization, and/or biocompatibility experience.
- Requires a minimum of 2 years of prior experience supervising or managing others.
- Experience in the front room of FDA inspections or notified body audits.
- Experience serving as a subject matter expert during audits, inspections, or regulatory assessments.
- Demonstrated understanding of the industrial sterilization business and contract sterilizer operations.
- Experience supporting microbiology and sterilization programs within a regulated manufacturing environment.
- Experience with controlled environment monitoring, process water systems, and/or industrial sterilization processes such as Ethylene Oxide (EO), Vaporized Hydrogen Peroxide (VHP), Moist Heat, Dry Heat, or Radiation sterilization.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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.
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
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