Senior Sterilization Engineer

Dexcom Inc.; Bengaluru; On-site; INR 1,200,000 - 1,500,000; Full time

Benefits offered by this job

Comprehensive benefits program

In-house learning programs

Global growth opportunities

Job summary

Dexcom Inc. in Bengaluru is looking for a Senior Engineer with expertise in sterilization modalities, particularly in ethylene oxide. This role involves overseeing sterilization validation and ensuring compliance with regulatory standards.

The candidate will be responsible for developing protocols, mentoring teams, and supporting cross-functional collaboration to establish global sterilization strategies. The position promises a dynamic learning environment and growth opportunities within the innovative field of CGM technology.

Qualifications

• In-depth knowledge of sterilization modalities with hands-on experience in validations.
• Experience with cleanroom standards and quality systems.
• Strong background in laboratory testing including sterility and bioburden.

Responsibilities

• Lead sterilization validation and requalification programs.
• Develop IQ/OQ/PQ protocols and reports.
• Consult cross-functional teams on sterilization strategies.

Skills

Sterilization modalities

Ethylene Oxide sterilization

ISO 11135 knowledge

Regulatory compliance

Tools

ISO 13485

FDA guidelines

Job description

About the Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM) and is expanding beyond diabetes to empower people to take control of their health.

Meet the Team

The R&D Mechanical Engineering Team focuses on the feasibility and development of next‑generation products at Dexcom. We are seeking a Senior Engineer with a background in sterilization modalities, specifically ethylene oxide cycle development, validation, and implementation.

Responsibilities

• Lead and oversee sterilization validation, requalification, and product adoption programs while ensuring quality, regulatory, and environmental compliance.
• Strategize and lead product disposition activities and characterize products as necessary.
• Develop IQ/OQ/PQ protocols and reports.
• Serve as an experienced subject‑matter expert in multiple sterilization technologies for terminally sterilized devices and provide technical guidance in audit settings, both externally and internally.
• Consult and support cross‑functional teams to shape the overall global sterilization strategy and mentor individuals regarding sterilization processes and best practices.

Qualifications

• In‑depth knowledge of at least two sterilization modalities with hands‑on experience in sterilization validations and product adoptions.
• Strong knowledge of Ethylene Oxide sterilization and ISO 11135 with guidance documents such as ISO‑10993‑7, TIR‑28, and ISO‑11137.
• Familiarity with FDA, AAMI, ISO guidance (ISO 11137, ISO TIR 13004, AAMI TIR 39, ISO 14160, ISO 17665) and microbiology standards (ISO 11737 series, ST72).
• Experience with cleanroom standards (ISO 14644 series, ISO 14698, AAMI TIR 52, TIR17) and quality systems (ISO 13485).
• Knowledge of sterility assurance systems, sterile barrier systems, risk‑based evaluations, material compatibilities, and product dispositions.
• Experience with laboratory testing including sterility, suitability, bioburden, LAL, and environmental monitoring programs.

Benefits

• Front‑row seat to life‑changing CGM technology.

• Full and comprehensive benefits program.

• Growth opportunities on a global scale.

• In‑house learning programs and qualified tuition reimbursement.

• Supportive, innovative work environment committed to employees, customers, and communities.

Travel Requirements

15–25% travel.