Medtronic plc
Senior Microbiologist - Sterilization page is loaded## Senior Microbiologist - Sterilizationremote type:
Hybridlocations:
Danvers, Massachusetts, United States of Americatime type:
Full timeposted on:
Posted Todaytime left to apply:
End Date: January 7, 2026 (30+ days left to apply)job requisition id:
R50618We anticipate the application window for this opening will close on - 7 Jan 2026Position Description:
Sr. Microbiologist Sterilization for Medtronic, Inc located in Danvers, MA.
Responsible for products in the form of finished medical devices within the Interventional Vascular/ Cardiac Rhythm Disease Management Business supporting on-market product sterilization validations to include product sterilization validations Microbial Performance Qualification and Process Performance Qualification (MPQs/PPQs). Responsible for coordinating laboratory and sterilization internal audit processes.
Responsible for Industrial Ethylene Oxide (EO) Sterilization for Medical Devices and CAPA (Corrective Action Preventive Action). Navigate the complexities of various government and industry regulations to include FDA 21 CFR 820, ISO 11135, ISO13485, ISO 11137, ISO 11737, ISO 14644, and ISO 10993-7. Coordinate Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Commission/Re-commission EO Sterilization Chambers, Sterilization adoptions, and Radiation Dose Audits (Gamma and Ebeam). Leverage Good Manufacturing Practices (GMP), Aseptic Technique, Laboratory Information Mgmt. System (LIMS), Good Laboratory Practice (GLP), and Environmental Monitoring. Responsible for various product sampling for Bioburden and Bacterial Endotoxin testing.
Leverage compendial Association for the Advancement of Medical Instrumentation (AAMI) and United States Pharmacopeia (USP) methodologies and techniques. Leverage knowledge from being a Certified Industrial Sterilization Specialist (CISS). Relocation assistance not available for this position. \*Position is required to be onsite in Danvers, MA, 4 days per week, and permits remote work 1 day per week.
#LI-DNI.Basic Qualifications:
Masters’ Degree or foreign equivalent in Microbiology, Biology, Chemistry, Biological Engineering, Chemical Engineering or related engineering or scientific field and two (2) years of experience as a Microbiologist, sterilization engineer or related occupation Must possess at least two (2) years’ experience with each of the following: Laboratory and sterilization internal audit; Industrial EO Sterilization for Medical Devices and CAPA; FDA 21 CFR 820, ISO 11135, ISO 13485, ISO11137, ISO11737, ISO 14644, and ISO 10993-7; IQ/OQ/MPQ/PPQ, Commissioning/Re-commissioning for EO Sterilization Chambers, Sterilization adoptions, and Radiation Dose Audits (Gamma and Ebeam); GMP, Aseptic Technique, LIMS, GLP, and Environmental Monitoring; Product sampling for Bioburden and Bacterial Endotoxin testing; Compendial (AAMI & USP) methodologies and techniques.
The following certification is required: Certified Industrial Sterilization Specialist (CISS)Salary: $119,000 to $145,200 per yearThe following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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).The following benefits and additional compensation are available to all regular employees: 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).Regular employees are those who are not temporary, such as interns.
Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.Further details are available at the link below:* **Build** a better future, amplifying your impact on the causes that matter to you and the world* **Grow** a career reflective of your passion and abilities* **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learningThese commitments set our team apart from the rest:**Experiences that put people first**. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.**Life-transforming technologies**. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.**Better outcomes for our world**. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.**Insight-driven care**. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in careIt is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click .For updates on job applications, please go to the candidate login page and sign in to check your application status.If you need assistance completing your application please email AskHR@medtronic.comTo request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com #J-18808-Ljbffr
Hybridlocations:
Danvers, Massachusetts, United States of Americatime type:
Full timeposted on:
Posted Todaytime left to apply:
End Date: January 7, 2026 (30+ days left to apply)job requisition id:
R50618We anticipate the application window for this opening will close on - 7 Jan 2026Position Description:
Sr. Microbiologist Sterilization for Medtronic, Inc located in Danvers, MA.
Responsible for products in the form of finished medical devices within the Interventional Vascular/ Cardiac Rhythm Disease Management Business supporting on-market product sterilization validations to include product sterilization validations Microbial Performance Qualification and Process Performance Qualification (MPQs/PPQs). Responsible for coordinating laboratory and sterilization internal audit processes.
Responsible for Industrial Ethylene Oxide (EO) Sterilization for Medical Devices and CAPA (Corrective Action Preventive Action). Navigate the complexities of various government and industry regulations to include FDA 21 CFR 820, ISO 11135, ISO13485, ISO 11137, ISO 11737, ISO 14644, and ISO 10993-7. Coordinate Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Commission/Re-commission EO Sterilization Chambers, Sterilization adoptions, and Radiation Dose Audits (Gamma and Ebeam). Leverage Good Manufacturing Practices (GMP), Aseptic Technique, Laboratory Information Mgmt. System (LIMS), Good Laboratory Practice (GLP), and Environmental Monitoring. Responsible for various product sampling for Bioburden and Bacterial Endotoxin testing.
Leverage compendial Association for the Advancement of Medical Instrumentation (AAMI) and United States Pharmacopeia (USP) methodologies and techniques. Leverage knowledge from being a Certified Industrial Sterilization Specialist (CISS). Relocation assistance not available for this position. \*Position is required to be onsite in Danvers, MA, 4 days per week, and permits remote work 1 day per week.
#LI-DNI.Basic Qualifications:
Masters’ Degree or foreign equivalent in Microbiology, Biology, Chemistry, Biological Engineering, Chemical Engineering or related engineering or scientific field and two (2) years of experience as a Microbiologist, sterilization engineer or related occupation Must possess at least two (2) years’ experience with each of the following: Laboratory and sterilization internal audit; Industrial EO Sterilization for Medical Devices and CAPA; FDA 21 CFR 820, ISO 11135, ISO 13485, ISO11137, ISO11737, ISO 14644, and ISO 10993-7; IQ/OQ/MPQ/PPQ, Commissioning/Re-commissioning for EO Sterilization Chambers, Sterilization adoptions, and Radiation Dose Audits (Gamma and Ebeam); GMP, Aseptic Technique, LIMS, GLP, and Environmental Monitoring; Product sampling for Bioburden and Bacterial Endotoxin testing; Compendial (AAMI & USP) methodologies and techniques.
The following certification is required: Certified Industrial Sterilization Specialist (CISS)Salary: $119,000 to $145,200 per yearThe following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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).The following benefits and additional compensation are available to all regular employees: 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).Regular employees are those who are not temporary, such as interns.
Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.Further details are available at the link below:* **Build** a better future, amplifying your impact on the causes that matter to you and the world* **Grow** a career reflective of your passion and abilities* **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learningThese commitments set our team apart from the rest:**Experiences that put people first**. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.**Life-transforming technologies**. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.**Better outcomes for our world**. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.**Insight-driven care**. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in careIt is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click .For updates on job applications, please go to the candidate login page and sign in to check your application status.If you need assistance completing your application please email AskHR@medtronic.comTo request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com #J-18808-Ljbffr