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Research & Development
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19000H3X Requisition #
Careers that Change Lives

In this exciting position you will interface with Manufacturing, Quality, Engineering and Regulatory Affairs to define and oversee environmental and sterilization control processes to assure that Medtronic Danvers medical devices consistently comply with FDA, ISO and Medtronic requirements.

CVG

The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.


CORONARY AND STRUCTURAL HEART provides interventional devices to treat coronary arteries that are blocked by atherosclerotic plaque and devices and therapies to treat structural defects of the heart.


A Day in the Life

 

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

  • Manages the design, control and monitoring of ethylene oxide and gamma sterilization processes including writing sterilization validation and annual revalidation protocols and reports and/or reviewing and approving protocols and reports provided to Medtronic by contract manufacturers.  
  • Reviews sterile load cycle data and performs sterile load release for finished product lots manufactured by Medtronic Danvers or contract manufacturers.  
  • Administers the Environmental Monitoring Program for the Danvers manufacturing areas including viable and non-viable particulate counts, product bio-burden, water and surface microbial levels, etc. to ensure an appropriately controlled environment meeting regulatory expectations and industry standards. Communicates detailed information regarding monitoring results and trends to Manufacturing and Quality; recommends revisions to monitoring program and/or manufacturing process controls and ensures effective corrective actions are implemented, where necessary.  
  • Reviews and approves personnel hygiene and plant cleaning and pest/vermin control practices.  Provides microbiological technical expertise to the Facilities department regarding cleaning and contamination control.  
  • Provides microbial technical expertise during new product development activities, process modification studies and failure investigations regarding microbiological contamination control.  Serves as technical liaison with functional groups, contract manufacturing sites and sterilization sites.  
  • Coordinates the biocompatibility testing of new products and materials ensuring that all required test results are reviewed and reports approved to meet project deadlines. 
  • Provides microbiology support to the Regulatory Affairs department in preparing submissions to regulatory agencies and notified bodies. 
  • Reviews Supplier Change Control (SCC) notifications for impact to sterilization/microbial testing and establishes the change qualification approach where necessary. 
  • Provides microbiological technical expertise to the Purchasing department in the selection and certification of component vendors.  
  • Performs audits of external sterilization contractors as well as new or existing finished good contract manufacturers.  
  • Provides training when necessary to employees regarding product microbial and particulate contamination control. 
  • Participates in the CVG Microbiology Council as the Danvers site representative.
 
Must Have: Minimum Requirements

Bachelor's degree in Microbiology or technical field with 4+ years experience in the industrial microbiology experience in the medical device or pharmaceutical industry


Nice to Have
  • Experience with ethylene oxide and gamma sterilization processes
  • Graduate degree in Microbiology
  • Documented training or certification in international and domestic standards, policies or requirements
  • Proven management and interpersonal skills
  • Excellent organizational and judgment skills
  • Ability to maintain and generate accurate records
  • Strong written, verbal communication skills
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 physical demands described within the Responsibilities 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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