Medtronic · 22 hours ago
Microbiology & Sterilization Manager
Medtronic is a global leader in healthcare technology, committed to alleviating pain and restoring health. The Microbiology & Sterilization Manager will lead a team responsible for sterility assurance, microbiology, and environmental controls across multiple manufacturing sites, ensuring the quality and compliance of medical devices. This role involves guiding laboratory activities, monitoring key performance indicators, and implementing continuous improvement initiatives in microbiology and sterilization processes.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Guide engineers and scientists who analyze chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company's quality program
Oversee local / site-based laboratory activities such as preparation, cleaning, disinfection, and/or sterilization of instruments, materials, products, and/or supplies; qualitative tests or quantitative assays on samples using techniques that may range from use of traditional analytical instruments to highly modern and automated instrumentation
Measure and monitor KPIs for sites under their responsibility and report these to leadership
Write protocols and procedures describing how to clean, sterilize, and/or deliver sterile products, supplies, and/or instruments
Interpret and evaluate laboratory analyses for accuracy and precision; verify test results against specifications and recommend and implement corrective action where necessary
Develop and implement procedures and protocols for management of controlled environments
Ensure microbiological quality of medical devices and controlled environments at assigned sites; lead corrective and preventive action (CAPA) and continuous improvement activities
Identify and implement opportunities for improvement in microbiology and sterility assurance processes with respect to quality and efficiency
May also be involved in establishing microbiology and sterilization requirements for the transfer of new products and test methodology from R&D to manufacturing
Serve as the Subject Matter Expert (SME) for microbiology and sterility assurance at assigned sites and support audits and inspections, both internal and external (regulatory and health authorities)
Travel Required: Role requires 10% travel to multiple manufacturing sites in the Central Region
Qualification
Required
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
Experience in balancing the needs of operations and compliance
Strong writing and communication skills with the ability to influence others without direct authority
An empathic and candid leader that understands the power of the collective team and builds strong relationships
Experience as an SME for sterilization and microbiology in audit situations
Must be comfortable dealing with strong management teams and able to positively influence when necessary
Professionally represent the company with key industry bodies and where required, government agencies (i.e., US FDA, Notified Bodies)
Experience with validating and monitoring controlled environments, process water systems, and/or various sterilization modalities (Ethylene Oxide (EO), Vaporized Hydrogen Peroxide (VHP), Moist Heat, Dry Heat, and/or Radiation)
Requires practical knowledge in leading and managing the execution of processes, projects and tactics within medical device microbiology & sterilization
Preferred
Degree in Engineering or Technical Sciences (Microbiology, Chemistry, Biology, Biochemistry, Materials Science, etc.)
Experience in a highly regulated industry, preferably medical device, with global manufacturing
AAMI Certification (CISS) or ASM Certification (NRM)
An active participant in the development of industry standards impacting sterility assurance in pharma or medical devices as an active voting member of a working group; staying up to date with changing regulations and trends and actively sharing that knowledge with leadership
Benefits
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Company
Medtronic
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
H1B Sponsorship
Medtronic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)
Funding
Current Stage
Public CompanyTotal Funding
$18.16BKey Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B
Leadership Team
Recent News
2026-01-07
Company data provided by crunchbase