Microbiology & Sterilization Manager

Medtronic • Minneapolis, MN

1d • Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. In this vital position as a Microbiology & Sterilization Manager you will lead a team of talented technicians, scientists, and engineers with responsibility for sterility assurance, microbiology, and environmental controls across several manufacturing sites in the Central Region. The Microbiology & Sterility Assurance team plays a key role in transforming the future of healthcare and fulfilling the Medtronic Mission to alleviate pain, restore health, and extend life. The incumbent will report through the Central Region Sterility Assurance Leader as part of the Global Operations and Supply Chain Quality organization. Responsibilities may include the following and other duties may be assigned. 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. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Requirements

• 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.
• 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.

Nice To Haves

• 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.

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).

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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, and 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees