Microbiologist-Sterilization II at Medtronic in Santa Ana, California

Job Description:

Careers that Change Lives

A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

In this exciting role as a Microbiologist-Sterilization II you will have responsibility for supporting on market product sterilization validations. You will have responsibility for sustaining sterilization work and to support of changes to existing products and introduction of new products. These validations include product sterilization validations, along with product and process validations. The position provides technical solution to achieve validated sterilization processes for new and existing products. Updates to routine sterilization procedures and related specifications. Supports and leads team with assessments of new products or changes to existing products.

A Day in the Life

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

• Work relatively independently with guidance and direction from senior members of the staff and manager.
• Assure all Quality requirements are in compliance with regulations and product specifications
• Provide new product development sterilization / microbiology validation support
• Perform, coordinate, execute, and summarize all areas of sterilization validation (EtO, Steam, and Liquid Chemical sterilization)
• Work with little guidance to design and validate sterilization cycles for new products including new sterilizer IQ/OQ/PQ reports, calibration, and production support.
• Work with little guidance to develop, implement and maintain sterilization processes, certifications and procedures for the sterilization operations within Medtronic.
• Support internal and external audits
• Prepare written responses to regulatory questions
• Review engineering change orders.
• Resolve non conformances and implement corrective action
• Work with Facility Maintenance and other departments for any Sterilizer, CEA, or Lab improvement/corrective activities.
• Participate in special projects as assigned.
• Reviews Supplier Change Control (SCC) notifications for impact to sterilization/microbial testing.
• Actively involved with Purchasing department for microbiological technical expertise to the in the selection and certification of component vendors.
• Assuring that the Microbiology / Sterilization function is maintained per industry standards.

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 2+ years of work experience in microbiology and sterilization experience OR Advanced degree in science or technical field with 0+ years of work experience in microbiology and sterilization experience.

Nice to Have

• Strong leadership skill
• Project management experience
• Strong cGMP skills and knowledge of good documentation practices
• Good written and verbal communication skills, communicating clearly and concisely, both orally and in writing
• Proficient in Math skills, especially in Microbiology/Sterilization Science math formulas and calculations
• Computer literate with focus on LIMS, Excel, Word, Power Point and Project
• Good in statistical techniques
• Presentation skills
• Knowledge of laboratory safety
• Demonstrate good documentation practices.
• Knowledge of GMP, ISO 9001:13485 and MDD
• Knowledgeable in sterilization methods such as ISO 11135, ISO 14644 series, ISO 17665, ISO 14160, and microbiological test methods.
• Expertise in microbiological identification methods

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)