Senior Microbiologist - Sterilization at Medtronic

Danvers, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Master’s Degree or foreign equivalent in Microbiology, Biology, Chemistry, Biological Engineering, Chemical Engineering or related engineering or scientific field
Two (2) years of experience as a Microbiologist, sterilization engineer or related occupation
At least two (2) years’ experience with Laboratory and sterilization internal audit
At least two (2) years’ experience with Industrial EO Sterilization for Medical Devices and CAPA
At least two (2) years’ experience with FDA 21 CFR 820, ISO 11135, ISO 13485, ISO 11137, ISO 11737, ISO 14644, and ISO 10993-7
At least two (2) years’ experience with IQ/OQ/MPQ/PPQ, Commissioning/Re-commissioning for EO Sterilization Chambers, Sterilization adoptions, and Radiation Dose Audits (Gamma and Ebeam)
At least two (2) years’ experience with GMP, Aseptic Technique, LIMS, GLP, and Environmental Monitoring
At least two (2) years’ experience with Product sampling for Bioburden and Bacterial Endotoxin testing
At least two (2) years’ experience with Compendial (AAMI & USP) methodologies and techniques
Certified Industrial Sterilization Specialist (CISS)

Responsibilities

Support on-market product sterilization validations, including Microbial Performance Qualification and Process Performance Qualification (MPQs/PPQs) for finished medical devices in Interventional Vascular/Cardiac Rhythm Disease Management Business
Coordinate laboratory and sterilization internal audit processes
Manage Industrial Ethylene Oxide (EO) Sterilization for Medical Devices and CAPA
Navigate government and industry regulations including FDA 21 CFR 820, ISO 11135, ISO 13485, 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 Management System (LIMS), Good Laboratory Practice (GLP), and Environmental Monitoring
Perform 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

Skills

Ethylene Oxide Sterilization

ISO 11135

ISO 13485

ISO 11137

ISO 14644

ISO 10993-7

GMP

Aseptic Technique

LIMS

GLP

Environmental Monitoring

Bioburden Testing

Bacterial Endotoxin Testing

IQ OQ PQ

AAMI

USP

CISS

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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