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Medtronic Microbiologist II in Danvers 37 Cherry Hill, Massachusetts

Careers that Change Lives

Peripheral Vascular Health is dedicated to the treatment of peripheral arterial and venous diseases. We offer our physician customers a comprehensive suite of products and therapies to treat varying degrees of vascular disease — disorders of the circulatory system outside of the brain and heart. Our goal is to help healthcare professionals save limbs, reduce pain, and treat disease — so their patients can get back to enjoying what they love.

A Day in the Life

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

  • 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.

  • Work with different Subject Matter Expert to evaluate changes impacting the product families, controlled rooms and critical systems.

  • 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

  • Bachelors degree required.

  • Minimum of one year experience in medical device, pharmaceutical or cosmetic field.

Nice to Have

  • Minimum of two years' experience in Sterilization Validation Processes and Sterility Testing

  • Project leadership skills

  • Knowledge of GLP & GMP requirements

  • Proficiency with Microsoft Office applications (Outlook, Word, Excel, Access, PowerPoint)

  • Strong communication skills, both oral and written

  • Demonstrates a systematic approach in carrying out assignments

  • Good organizational skills

  • Proven ability to prioritize, conduct, and meet project deadlines

  • Basic Statistics

  • Understanding of contamination control

  • Ability to deal with stress and schedules

  • Willingness to work overtime

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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It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.