17 days old

Sr Microbiologist-Sterilization - Remote within US

Medtronic
Mounds View, MN 55112 Work Remotely
  • Job Code
    21000NN2
  • Jobs Rated
    30th
Careers That Change Lives

In this exciting role as a Senior Microbiologist, you will have responsibility to work on assignments that are complex in nature where judgment and initiative are required in resolving problems and making recommendations. Provides input to Supervisor of Microbiology regarding sterilization, testing and technical issues. Works with the contract sterilizers to maintain sterilization cycles using either Gamma Sterilization or Ethylene Oxide Sterilization in accordance with all industry, Federal and international guidance documents/regulations. Interacts with the Regulatory, Quality, Packaging and R&D Engineering in Memphis to maintain the microbiological specifications and test plans necessary to ensure compliance with the overall Quality Requirements. Assists with microbiological and sterilization issues affecting manufacturing. Serves as consultant for laboratory on technical issues. Develops procedures for laboratory testing. Moderate supervision

CST

Cranial and Spinal Technologies (CST), an operating unit of Medtronic, shapes surgery for the better; delivering cranial, spinal, and orthopedic solutions. We are a leader in therapeutic biologics. We partner with other healthcare stakeholders to accelerate ground-breaking innovations that can improve surgical efficiencies and help create better outcomes for more patients.

The Cranial and Spinal Technologies operating unit brings all of our cranial and spinal technology businesses together into one cross-functional, collaborative group to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.

CORE SPINE AND BIOLOGICS offers treatment for degenerative spinal conditions, spinal deformity, herniated discs, spinal trauma and tumors, general/pediatric ventricular catheter placement, depth electrode/lead-probe placement, and cranial biopsies.

ENABLING TECHNOLOGIES offers surgical navigation systems, surgical imaging systems, powered surgical instruments, spine robotics, electrosurgicalproducts, and interoperative nerve monitoring systems as support systems in the treatment of spine and cranial disease states.

CHINA ORTHOPEDICS provides economic value to healthcare providers through innovative products and solutions.

A Day in the Life

Interacts with Purchasing and Contract Sterilization/Test Facilities to ensure that the Sterilization requirements and product testing procedures are clear, complete and understood.

Works with the internal personnel as well as with the Contract Sterilization and Test facilities to establish specifications and coordinates the new product sterilization validations as well as the quarterly validations.

Coordinates yearly and quarterly product re-verifications (Irradiation & Ethylene Oxide)

Coordinate lethality testing for EO product, or process qualifications

Product Release (EO & Gamma)

Develop and Coordinate Steam Sterilization Studies

Develop and Coordinate Reusable Device Validation (Cleaning Studies)

Develop and Coordinate Profiling Protocols

Develop Equipment Validations (steam, dry heat, incubators)

Documentation of all test procedures and validations

Provide guidance to other non-exempt personnel within/outside the department

Acts as technical advisor for customers and projects regarding sterilization, contamination control, GLP, process qualification, and test documentation.

Review and revise manufacturing related documents, protocols and procedures; assure manufacturing needs are met.

Review laboratory protocols for accuracy, consistency, and compliance with applicable standards.

Develop procedures for process/product development testing and test methods that meet industry standards and Medtronic QA and Corporate Compliance requirements. Use experience and technical expertise to assist department.

Must Have: Minimum Requirements

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

Bachelor's Degree in Science or technical field with 4 years of work experience in microbiology, sterilization, and/or biocompatibility experience OR Advanced Degree in Science or technical field with 2 years of work experience in microbiology, sterilization, and/or biocompatibility experience.

Nice to Have (Preferred Qualifications)

  • Minimum of two 2 years' experience in Sterilization Validation Processes and Sterility Testing
  • Hands on experience and deep knowledge of radiation sterilization (dose mapping, dose setting, dose audits, routine processing, sterilization validation, bioburden validation, microbial characterizations, VDmax methodology, and Method 1 methodology).
  • Demonstrates understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
  • Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with the organizations objectives and quality system requirements.
  • Familiar with ISO and guidance documents related to sterility assurance - sterilization (ISO 11137, ISO TIR 13004, AAMI TIR 39), microbiology (ISO 11737 series), cleanrooms (ISO 14644 series, ISO 14698, AAMI TIR 52), and quality systems (ISO 13485)
  • Act as a SME on sterility assurance and as a point-of-contact for regulatory audits.
  • Manages external standards pertaining to sterilization and microbiology for medical devices
  • Reviews sterilization deviations and provides technical support to assist with the release of sterilization loads and ensure compliance to procedures and regulatory requirements and ensure product quality issues are addressed
  • Possess a proactive-preventative mind set and actively pursues continuous improvements to ensure the continued success of the sterility assurance program.
  • Must be an effective team player intra-departmentally and cross functionally.
  • Leadership skills that include project management, training and presentation, and the ability to champion teamwork.
  • Ability to lead, develop, validate, implement, and defend business processes that impact sterilization.
  • Knowledge to execute and document investigations related to environmental and product bioburden non-conformances and equipment's out of tolerance in compliance with quality system requirements.

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)

Travel can be up to 15 - 20%.

Additional Information

  • Posting Date: Sep 9, 2021
  • Travel: No






Jobs Rated Reports for Biologist

Posted: 2021-09-11 Expires: 2021-10-10
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Sr Microbiologist-Sterilization - Remote within US

Medtronic
Mounds View, MN 55112

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