We anticipate the application window for this opening will close on - 17 Jul 2026

 

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

         

         

The Senior Sterilization Microbiologist is responsible for leading the development, validation, and ongoing control of sterilization processes (e.g., EO, steam, radiation) to ensure product safety, regulatory compliance, and process robustness. This role provides technical expertise and strategic direction for microbiological aspects of sterilization across manufacturing and quality systems.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require 10% of travel to enhance collaboration and ensure successful completion of projects.

Key Responsibilities

• Lead sterilization validation activities (IQ/OQ/PQ, MPQ/PPQ) for new and existing products.

• Develop and review sterilization protocols, reports, and cycle parameters.

• Serve as SME for sterilization processes (EO, Gamma, E-beam, Steam).

• Ensure compliance with regulatory standards (FDA, ISO 11135, ISO 11137, ISO 17665).

• Support investigations related to bioburden, sterility failures, and deviations.

• Oversee bioburden, endotoxin, and environmental monitoring programs.

• Collaborate with cross-functional teams (Quality, Engineering, Operations, external suppliers like sterilization vendors).

• Review and approve changes impacting sterilization processes.

• Provide guidance during audits and regulatory inspections.

• Drive continuous improvement initiatives in sterilization and microbiology processes.

​Key Skills

• Deep expertise in sterilization technologies and microbiology

• Strong analytical and problem-solving skills

• Leadership and project management capability

• Excellent technical writing and communication skills

• Ability to work cross-functionally and with external partners

Typical Work Environment

• Manufacturing plants, laboratories, and collaboration with external sterilization providers.

• Involvement in validation runs, audits, and technical reviews

• 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 in your applicant profile. 

• Requires a Bachelor's degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.

Nice to Have

• Requires a Bachelor’s or Master’s degree in Microbiology, Biology, or related field.

• Requires 5 to 10 years of experience in sterilization microbiology (medical devices/pharma preferred).

• Strong knowledge of sterilization validation and microbiological methods.

• Experience with regulatory submissions and audits.

• Experience with LIMS, SAP, MES, and BPCS required.

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.

Physical Job Requirements

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 jo