Senior Sterilization Engineer

Dexcom; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Comprehensive benefits program

Career development opportunities

Growth on a global scale

Job summary

Dexcom in Bengaluru is seeking a Senior Engineer specializing in sterilization modalities, particularly in ethylene oxide cycle development. Responsible for overseeing sterilization validation and regulatory compliance, the ideal candidate will have in-depth knowledge of multiple sterilization technologies and standards including ISO 11135. This role offers significant growth opportunities within a global leader in continuous glucose monitoring technology. You will be part of an innovative organization focused on empowering people to take control of their health.

Qualifications

• Proven in-depth knowledge of at least 2+ sterilization modalities.
• Strong knowledge of Ethylene Oxide sterilization and ISO 11135.
• Familiar with FDA, AAMI, ISO, and other guidance documents.

Responsibilities

• Lead and oversee sterilization validation and product adoption programs.
• Develop IQ/OQ/PQ protocols/reports as necessary.
• Provide technical guidance in audit settings.

Skills

Sterilization modalities

Ethylene Oxide sterilization

Regulatory compliance

Microbiology

Laboratory testing

Job description

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.

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%