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Research & Development
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19000JNN Requisition #

Careers That Change Lives

 

In this exciting role as a Microbiologist II you will have responsibility for Diabetes Products Environmental Monitoring. You will be a key member of the team validating cleanrooms and working closely with sterilization specialists. Work includes development and maintenance of validations for new or existing cleanrooms and capacity expansion projects. These validations will support changes to existing products and introduction of new products sterilized by electron beam radiation or ethylene oxide. Trending of environmental data will be used with product bioburden data supporting sterilization validations.

 

The position provides technical solutions to achieve validated processes for cleanrooms supporting new and existing products manufactured in the Northridge facility. Key activities include assessment of proposed changes to cleanrooms for potential impact to products, creating and maintaining procedures, specifications, and reports.

 

DIABETES

Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers.

ADVANCED INSULIN MANAGEMENT is focused on serving patients in need of insulin pump therapy. The Advanced Insulin Management (AIM) business unit is our history and our heritage and remains focused on driving increased automation to our insulin pump platform, to maximize the time people are within a set target glucose range. The ultimate goal is to develop a fully automated closed loop system.

NON-INTENSIVE DIABETES THERAPIES play a prominent role in our strategy to transform our business into a holistic diabetes management company. As we look to support patients across the disease continuum, it is critical for us to continue expanding our reach to type 2 patients in need of better diagnostic and monitoring solutions to manage their glucose levels.

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

 

Visit www.medtronicdiabetes.com  to see an overview of the products in our Diabetes product portfolio.

 
 
A Day in the Life

Responsibilities may include the following and other duties may be assigned.

  • Collecting data supporting routine production and validation of new or modified cleanrooms inputting trending of Environmental Monitoring testing into applicable validated trending or statistical analysis software as instructed.
  • Interprets and evaluates the analysis in terms of accuracy and precision compared against established specifications and recommends corrective action where necessary.
  • Reviews/writes Validation protocols and reports for Sterilization & Environmental Monitoring group
  • Generates Control charts: commonly used statistical tools for monitoring and improving processes
  • Generates/reviews Out of Compliance and Out of Tolerance reports, address CAPA issues
  • Prepare/assists/answers audit issues for internal corporate, FDA and GMED
  • Complete initial investigation documentation of out of specification results. Participate in investigation and summary of results for non-conformances.
  • Participates in the preparation of lab investigations, summaries and non-conformance reports.
  • Responsible for accuracy and integrity of documentation generated, as well as compliance with cGMP’s and Quality Control guidelines issued by FDA

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

 
Bachelors Degree with 2+ years of experience in Biological Science, Microbiology, Biochemistry, Life Science or Engineering Biomedical Engineering or similar Technical discipline and/or Quality or Advanced Degree with 0+ years of experience in Biological Science, Microbiology, Biochemistry, Life Science or Engineering Biomedical Engineering or similar Technical discipline and/or Quality
 
Nice to Have (Strongly Preferred)

  • Knowledge of Code of Federal Regulations (21 CFR – Parts 210, 211, 820 and Part 4), ISO 13485
  • Ability to analyze and interpret scientific and technical journals
  • Ability to respond to common inquiries from management and quality assurance
  • Ability to write procedures and reports that conform to prescribed style and format. Ability to effectively present information.
  • Ability to learn and use multiple Learning Management System (LMS)
  • Thorough knowledge of general laboratory practices and procedures, GMP requirements
  • Thorough knowledge of general laboratory practices and procedures.
  • Working knowledge of environmental monitoring
  • Work must show accuracy, attention to detail, completeness of documentation, and be well organized.
  • Experience performing laboratory data interpretation including working with mathematical concepts relevant to the laboratory setting
  • Experience drafting documentation in compliance with medical device regulations and processing through Documentation Change Control process
  • Ability to work effectively with diverse teams and individuals from varied disciplines
  • Ability to coordinate work through outside service laboratories
  • Ability to multitask and track multiple projects at various stages
  • Ability to work with changing priorities in a fast paced, dynamic environment
  • Work must show accuracy, attention to detail, completeness of documentation, and be well organized.
  • Awareness of international standards, particularly those applicable to controlled environments.
  • Experience in Environmental Monitoring/Microbiology/laboratory procedures
  • Relevant experience in an Environmental Monitoring, QC, microbiology lab (QC or clinical lab experience preferred)
  • Experience using validated trending software and statistical analysis software
  • Knowledge in cGMP and GLP methodologies and techniques.
 
About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

 

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

 

Physical Job Requirements


The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

 

The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 
No travel
 
 

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