Senior Microbiologist - Sterilization

About the position

The Senior Microbiologist - Sterilization position at Medtronic is responsible for overseeing the medical device sterilization program and biocontamination control at the Boulder, Colorado site. This role involves validating and maintaining sterilization processes, primarily using ethylene oxide and radiation, while ensuring compliance with regulatory standards. The Senior Microbiologist will act as a subject matter expert, collaborating with cross-functional teams to ensure products are manufactured in a microbially controlled environment and meet sterility assurance levels.

Responsibilities

• Responsible for new product sterilization validations utilizing ethylene oxide, radiation, and other modalities.
• Demonstrate the continued effectiveness of commercial product sterilization processes including annual reviews, periodic requalifications, and product dose audits.
• Assess and document the sterilization impact of processing deviations and product changes.
• Coordinate sterilization or microbiological testing in compliance with ISO, EN, and USP with contract sterilization facilities and test laboratories.
• Draft device submissions and respond to regulatory inquiries in collaboration with the Regulatory Affairs group.
• Act as the site SME for sterilization and controlled environment questions during audits by regulatory agencies and internal audits.
• Travel to other Medtronic sites and laboratories to support audits of sterilization and microbiological programs.
• Evaluate OOS investigations into controlled environment microbial and particulate monitoring and work with teams to determine product impact and required testing.
• Review changes to controlled environments and perform risk assessments for routine sampling adjustments.

Requirements

• Bachelor's degree required.
• Minimum of 4 years of relevant experience, or advanced degree with 2 years of experience.

Nice-to-haves

• Expertise in Ethylene Oxide and Radiation based sterilization modalities.
• Competence using a variety of computer software applications.
• Strong working knowledge of ISO standards related to sterilization and cleanroom environments.
• Experience operating within quality system requirements applicable to the medical device industry.
• AAMI CISS certification in EO and/or Radiation.
• Strong problem solving and analytical skills.
• Excellent written communication skills.
• Ability to function independently as well as in a team environment.

Benefits

• Competitive salary and flexible benefits package.
• Short-term incentive eligibility through the Medtronic Incentive Plan (MIP).
• Comprehensive benefits and resources to support employees at every career and life stage.