Position Description

Provide technical solutions to product development organization and manufacturing using microbiological theory and practice. Offer and implement original solutions to new problems that enable the product development process and manufacturing. Independently develop approach to solutions. Select and apply new applications that achieve improved cost effectiveness, meet regulatory requirements and protect human health.

Position Responsibilities

* Provide online production support for the clean room and sterilization areas
* Provide new product development sterilization / microbiology validation support
* Perform, coordinate, execute, and summarize all areas of sterilization validation (EtO, radiation, and steam)
* Use well developed knowledge of product sterilization to assess and supply strategic direction for sterilization. Assessment is made with knowledge of product requirements, corporate objectives, regulatory requirements, schedule, cost objectives and personnel quality.
* Work relatively independently to design and validate sterilization cycles for new products including new sterilizer IQ/OQ/PQ reports, calibration, and production support.
* Provides project management through all stages of sterilization including product design review, test design, and certification. Communicate and review these plans with management or project leaders.
* Work relatively independently to develop, implement and maintain sterilization processes, certifications and procedures for the sterilization operations within Medtronic.
* Provide guidance to others relative to the technical discipline and the operation of the department and Medtronic.
* Responsible for multiple product lines for a number of projects.
* Apply knowledge to the optimization of the sterilization process and work towards gaining credibility, reputation, and be responsible for multiple projects.
* Conduct and/or host internal and external audits to assess compliance to ISO, QRS and industry standards for sterilization, microbiology testing, and CEA compliance.
* Prepare written responses to FDA for IDE’s, PMA’s and PMA supplements.
* Update Sterilization Services technical procedures, MFG processes/work instructions, validation protocols/reports, CEA compliance documents
* Review engineering change orders.
* Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high quality work.

Basic Qualifications

* BS in Microbiology or Biology or Chemistry with the following experience:
* 5+ years related experience including 2+ years sterilization validation experience
* Experience with sterilization standards and compliance documents
* Experience with endotoxin testing, limits, and standards compliance
* Experience with microbiology lab testing, including bioburden and sterility testing
* Experience with CEA compliance and certification

Desired/Preferred Qualifications

* MS in Microbiology or related field
* 5+ years sterilization validation experience
* Proficiency in MS Word, Excel and Project
* Project Management experience
* Sterilization Microbiology
* Ability to work under press

Physical Job Requirements

* Must be able to sit/stand/walk 8 hours per day.
* Vision must be correctable to 20/20 in one eye and 20/40 in the other eye.