Senior Sterilization Engineer

Job description

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: The R&D Mechanical Engineering Team is responsible for the feasibility and development of next-generation products at Dexcom. We’re seeking a Senior Engineer with a background in sterilization modalities with a focus on ethylene oxide cycle development, validation and implementation. If you are passionate about creating solutions that enhance patient experience and product performance, we invite you to apply and contribute to our mission of empowering people to take control of their health. Where you come in: You will be able to lead and oversee sterilization validation, requalification, and product adoption programs and ensure quality, regulatory, environmental compliance as necessary. You will be able to strategize and lead any product disposition activities and characterize product as necessary. You will be able to develop any IQ/OQ/PQ protocols/reports as necessary. You will be able to act as an experienced subject matter expert in multiple sterilization technologies for terminally sterilized devices and provide technical guidance in an audit setting externally and internally. You will be able to consult and support cross functional teams to help shape the overall global sterilization strategy within the organization and help to mentor individuals regarding sterilization processes and best practices. What makes you successful: Proven in-depth knowledge of at least 2+ sterilization modalities with hands-on experience with sterilization validations, and product adoptions. Strong/in-depth knowledge of Ethylene Oxide sterilization and ISO 11135 and guidance documents (ISO-10993-7, TIR-28, ISO-11137). Familiar with FDA, AAMI, ISO and other guidance documents (ISO 11137, ISO TIR 13004, AAMI TIR 39, ISO14160, ISO17665), microbiology (ISO 11737 series, ST72), cleanrooms (ISO 14644 series, ISO 14698, AAMI TIR 52. TIR 17), and quality systems (ISO 13485) Experienced with sterility assurance systems, and familiar with sterile barrier systems, risk-based evaluations, material compatibilities, and product dispositions. Experienced with laboratory testing (sterility, suitability, bioburden, LAL, environmental monitoring programs). What you’ll get: · A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community . · A full and comprehensive benefits program. · Growth opportunities on a global scale. · Access to career development through in-house learning programs and/or qualified tuition reimbursement. · An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 15-25% To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.