Principal Microbiologist -Sterilization

We anticipate the application window for this opening will close on - 11 Feb 2025

 

Position Description:       

Principal Microbiologist- Sterilization for Medtronic, Inc., located in North Haven, CT. Analyze sterilization equipment, provide guidance, and support projects for the design, development, procurement, and deployment of equipment and supplies used for sterilization processing. Interpret and evaluate the analyses in terms of accuracy and precision compared against established specifications and recommend and implement corrective action where necessary. Responsible for sterilization equipment design and acquisition within Ethylene Oxide, Steam, Liquid Chemical, Radiation and Hydrogen Peroxide Sterilization modalities. Responsible for ensuring equipment capabilities for sterilization parametric release establishment and monitoring. Navigate the complexities of various government and industry regulations including FDA 21 CFR 820, ISO 11135, ISO 13485, ISO 11137, ISO 11138, ISO 11737, ISO 10993-7, and ISO 14160. Coordinate User Requirement Specifications (URS), Supplier Selection, Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for sterilization equipment. Design facility and equipment layouts for sterilization processing. Support in-house sterilization and “3M” sterilization equipment replacement. Leverage microbiological test methods for sterilization qualifications. Position works a hybrid model and will be onsite in North Haven, CT location – 2/3 days per week. Relocation assistance is not available for this position.

Basic Qualifications:        

Bachelor’s degree or foreign equivalent in Microbiology, Bioengineering, Chemistry or Chemical Engineering or related engineering or scientific field and five (5) years of progressively responsible experience as a microbiologist, sterilization engineer, manufacturing engineer or related occupation. Must possess at least five (5) years of experience with each of the following within Medical Device Industrial Sterilization: Ethylene Oxide, Steam, Liquid Chemical, Radiation or Hydrogen Peroxide Sterilization modalities and associated equipment; sterilization parametric release establishment and monitoring; FDA 21 CFR 820, ISO 11135, ISO 13485, ISO 11137, ISO 11138, ISO 11737, ISO 10993-7, and ISO 14160; URS, Supplier Selection, FAT, and IQ/OQ/PQ for sterilization equipment; design of facility and equipment layouts; in-house sterilization and understanding of “3M” sterilization equipment; and microbiological test methods. Position works a hybrid model and will be onsite in North Haven, CT location – 2/3 days per week.

Salary: $123,500 to $174,000 per year

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