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Research & Development
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19000HBX Requisition #
Careers that Change Lives
In this exciting role as a Sr Sterilization and Microbiology Supervisor you will have responsibility for supervision of Staff, Resources and Systems in support of Microbiology and Sterilization Services area within the Medtronic Danvers facility. 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. 

  • Supervision of Staff, Resources and Systems in support of Microbiology and Sterilization Services area within
  • the Medtronic Danvers facility.
  • Ensure compliance to all relevant standards and provide support during inspections and audits.
  • Lead by example and ensure that team is aligned to achieve operational and functional goals.
  • Build strong collaboration across departments, both internally and externally.
  • Provide technical direction to reports and peers as appropriate to ensure product and process quality
  • requirements are achieved.
  • Identify, monitor and act on out of trend and/or non-conformance results.
  • Develop technical competencies in the area and drive continuous improvement initiatives.
  • 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 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.
  • Coordinates the biocompatibility testing of new products and materials ensuring that all required test results
  • are reviewed and reports approved to meet project deadlines.
  • Reviews Supplier Change Control (SCC) notifications for impact to sterilization/microbial testing and
  • establishes the change qualification approach where necessary.
  • Perform/support audits of external sterilization contractors as well as new or existing finished good contract
  • manufacturers.
  • Participates in the CVG Microbiology Council as the Danvers site representative.

Must Have: Minimum Requirements
  • Bachelor's degree with 3+ years of industrial microbiology experience in the medical device or pharmaceutical industry 
  • OR an Advanced degree with 1+ years of industrial microbiology experience in the medical device or pharmaceutical industry
Nice to Have
  • 5+ years of sterilization validation experience. Desired/Preferred Qualifications · Graduate degree in Microbiology
  • Ability to develop technical solutions to complex problems
  • Ability to interact with Senior Leadership and demonstrate strategic thinking
  • Proven management and interpersonal skills
  • Strong written, verbal communication skills
  • Technical expertise in sterilization technologies including ETO, E-beam, Gamma and Steam Sterilization. Background in microbiology and biocompatibility desirable.
  • Working knowledge of FDA Quality System Requirements and ISO13485, ISO11737, ISO11135 and AAMI TIR16 and TIR28.
  • Good organizational and Project Management experience 
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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