Work primarily with IGT Devices products and processes that require sterilization and/or environmental controls used in the development or manufacture of Intravascular Ultrasound and Functional Measurement medical devices. This position will provide sterilization expertise as it relates to new product development, product and process sterilization validation, and routine assessment of sterilization services.)

　　Your ro le:

　　Ensures Sterilization functions operate according to procedures and provides direction to staff.

　　Provides expertise to sterilization, validation and microbiological methods and processes related to IGT Devices products designed and manufactured, as well as products purchased.

　　Assure appropriate action is taken relative to the release or quarantine of sterilized product.

　　Ensures that robust product sterilization and environmental monitoring process controls are established and maintained.

　　You're the right fit if:

　　You’ve acquired 5+ years of experience in Quality Operations in the medical device industry specifically in a sterilization and microbiology function.

　　Your skills include knowledgeable in the following Microbiology tests: LAL, Bioburden, Biologic Indicator (BI), Water sampling, pH testing, oil mist, moisture test and environmental monitoring; experience with operation and validation of ethylene oxide and radiation methods, knowledge in the validation process for equipment and critical systems; knowledge of FDA regulations, Quality Systems Regulations, ISO 13485, Good Laboratory Practices and Japan regulations

　　Knowledgeable of ANSI/AAMI/ISO 11135:2014 Sterilization of health care products —, ANSI/AAMI/ISO 11137: 2015 Sterilization of health care products

　　Knowledgeable of ISO 14644-1 through 14644-9: Clean rooms and associated controlled environments

　　You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

　　You have a Bachelors degree preferably in Microbiology or Engineering – or equivalent years of experience

　　You’re a highly analytical thinker with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes; flexible team player who thrives in environments requiring ability to effectively prioritize and juggle multiple concurrent projects; results-driven achiever with exemplary planning and organizational skills, along with a high degree of detail orientation. Innovative problem-solver who can generate workable solutions and assure implementation of those solutions.

　　About Philips

　　We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

　　Learn more about our business.

　　Discover our rich and exciting history.

　　Learn more about our purpose.

　　Read more about our employee benefits.

　　If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

　　Additional Information

　　US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

　　Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Plymouth MN

　　It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

　　As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

　　Equal Employment and Opportunity Employer/Disabled/Veteran