Staff Design Quality Engineer (Global Expansions)

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:

TheStaff Design Quality Engineer (Global Expansions)serves as the principal technical authority for design control, product risk management, and regulatory compliance across international markets. This role is vital for driving the regional adaptation, platform expansion, and localization of new and existing products. The ideal candidate ensures that local design requirements are fully integrated into our global product development lifecycle

Working cross-functionally with Systems Engineering, Design Engineering, Clinical, Regulatory Affairs, Quality, Manufacturing, Human Factors, and Post-Market Surveillance, this role integratesglobal medical device regulations– including FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, ISO 14971etc-into product development while ensuring patient safety and regulatory compliance.

Where you come in:

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You willserve as the subject matter expert (SME) responsible for aligning Design History Files (DHFs) with the compliancerequirements of target international markets

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Youwill act as the core team leadQuality Lead responsible forassessing the impact of change controls, CAPA’s andNon Conformance’son the overall system

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You will serve as the lead Quality contact for requests from regulatory agencies as part of global expansions

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You will act as theQuality Lead responsible for supporting investigations from CAPA’s and complaint investigations

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You will serve as the Quality Lead responsible foridentifying, prioritizing, communicating, and resolving quality issues

What makes you successful:

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You have proven experience in Design Quality Engineering and Assurance within the medical device industry.

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You must have a minimum of 8+ years of experience in medical device development.

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You bring at least 5+ years in leading and implementing global expansions in medical device development

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Youdemonstrateanability to collaborate with cross functional teams.

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Youpossessexceptional interpersonal, written, and verbal communication skills.​

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You are self-motivated with a collaborative, proactive, and accountable approach

Whatyou’llget:

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A front row seat tolife changingCGM technology.Learn about our brave #dexcomwarriors community.

- Afull andcomprehensive benefitsprogram.

- Growth opportunities on a global scale.

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Access tocareer development through in-house learning programs and/orqualifiedtuition reimbursement.

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Anexcitingandinnovative,industry-leading organizationcommitted to our employees,customers, and the communities we serve.

Travel Required:

- 5-15%

Experience and Education Requirements:

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Typically requires a Bachelor’s degree in a technical discipline, and a m