Boston Scientific Corporation
Purpose and Passion \u2022 Comprehensive Benefits \u2022 Life-Work Integration \u2022 Community \u2022 Career Growth At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we\u2019re solving some of the most important healthcare industry challenges. Together, we\u2019re one global team committed to making a difference in people\u2019s lives around the world. This is a place where you can find a career with meaningful purpose\u2014improving lives through your life\u2019s work. About the Role: Provides technical excellence in the field of Sterilization. Independently, or as a member of a team, develops, directs, and executes plans for sterilization projects. Compiles and analyzes validation data to establish technical specifications for sterilization of products. Your Responsibilities Will Include: Responsible for ensuring Boston Scientific products and processes are compliant to standards and regulations Selects techniques to solve complex sterilization related problems and makes sound recommendations. Summarizes, analyzes, and draws conclusions from sterilization test results. Designs and coordinates engineering tests and experiments related to sterilization. Coordinates, manages, and documents project goals and progress and recommends appropriate revisions. Assesses the feasibility and soundness of proposed sterilization evaluation tests, products or equipment. Responsible for sterilization evaluation documentation. Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success. May train and\/or provide work direction to more junior scientists or engineers. Demonstrates Product Life Cycle Process knowledge through delivery of high quality and high impact deliverables. Provides product submissions sterilization data and documentation for regulatory submissions Support internal and external audits as sterilization subject matter expert Manages sterilization activities to support product recertification projects Manages product and process sterilization validations Key participant in the development and validation of new sterilization cycles. Key role in qualification of new sterilization vendors and facilities Manage sterilization continuous improvement projects at site and contractor facilities Significant community of practice contributor to the development of sterilization related corporate policies and procedures Provide assistance and support to the sterilization, regulatory and quality groups as required. What We\u2019re Looking for In You: Minimum Qualifications: Bachelor\u2019s degree in Microbiology or related discipline and 2-4 years of experience in roles related to Sterilization and Microbiology Demonstrated understanding of MDD and FDA medical device requirements and Quality System standards Preferred Qualifications: Experience in product and process validation for Steam Sterilization and Ethylene Oxide sterilization methods Experience\/understanding in sterilization methods for re-useable med devices a plus Project Management experience is desirable
Boston Scientific Corporation
Website : http://www.bostonscientific.com
Our products and technologies are used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular, urological, women’s health, and chronic pain conditions. We continue to innovate in these areas and are extending our innovations into new geographies and high-growth adjacency markets.