Description

Provides technical solutions to product development and manufacturing organizations, using microbiological theory and practice. Offers and implements original solutions to new problems that facilitate successful product development and manufacturing processes. Selects and applies applications that achieve improved cost effectiveness, meet regulatory requirements, and protect human health. Independently determines and develops approach to solutions, using microbiology manager and appropriate team leaders for guidance when needed.

Position Responsibilities:
* Represents Microbiology as an extended team member of the Product Development Process (PDP) Team for the development of new projects, and ensures all Microbiology related issues are addressed for the PDP. Leads project team in solving difficult problems.
* Based on complete understanding of ISO11135 and ISO11137, works relatively independently to design and validate sterilization cycles for new products. Provides project management through all stages of sterilization including product design review, test design, and certification.
* Assesses new products and establishes protocols and reports to ensure that the raw materials, manufacturing procedures, and sterilization result in a biocompatible product.
* Answers questions and trains users how to apply technology to resolve issues or accomplish very specific definable tasks.
* Gathers information, conducts research to resolve issues and generate solutions. Uses applicable standards, written procedures, and academic understanding of microbiology principles to accomplish tasks.
* Represents Medtronic with outside customer contacts (sterilization vendors, biological contract laboratories, foreign and domestic regulatory bodies), as well as other Medtronic business divisions.
* Assists in the preparation and response to regulatory submissions on the following subjects: sterilization, biocompatibility, and manufacturing environment monitoring.
* Provide assistance and knowledge during regulatory/compliance body audits (FDA, BSI, PMDA, Medtronic Corporate).
* Other duties as defined by management.

Requirements

Basic Qualifications:
Highly proficient knowledge in Microbiology Principles (especially EO/radiation sterilization microbiology/methodologies, biocompatibility, clean room technologies), and applicable ISO/AAMI/ANSI standards and USP/ASTM test methods.

Very strong oral and written communication skills. Ability to work in a team environment and multi-task under stressful circumstances. Knowledgeable with Customer Focused Quality, QSIT, cGMP, GLP

Proficient knowledge of Computer software/hardware (MS Word, Excel, Project, PowerPoint), basic statistics, protocol and report preparation, microbiology laboratory methods.

Desired/Preferred Qualifications:
In addition to a strong sterilization background, biocompatibility, and manufacturing environment monitoring experience, knowledge of shelf life/stability testing, general analytical methods, packaging performance testing, and ICH/pharmaceutical methods are desired.

Physical Job Requirements:
The physical demands described here 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. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to stand, walk, lift, and reach with hands and arms. Specific vision abilities required by this job include normal vision.

Medtronic is an Equal Opportunity/Affirmative Action Employer.