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Sr. Manager, Design Quality Engineering - Product Compliance

Dexcom

San Diego, CASenior
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Location
San Diego, CA
Work model
On-Site
Level
Senior
Posted

About this role

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 Design Quality Engineering (DQE) team at Dexcom is made up of incredibly passionate, collaborative, motivated, and competent people that think big, serve with integrity, and follow through on their commitments without fail.  This team takes ownership in driving Design for Excellence (DfX) methodologies across the product lifecycle of Dexcom's on market products and future innovations, as well as leading strategies and supporting outcomes across our Design Control, Software Development Lifecycle (SDLC), Design Transfer, and Risk Management quality system processes. Where you come in: You will be the accountable Quality leader for Dexcom's Electrical Safety/Electromagnetic Compliance (EMC) and radio certifications across the entire product lifecycle.  This includes: Own global compliance strategy for IEC 60601 Electrical Safety and EMC standards across the CGM product portfolio, ensuring requirements are effectively integrated throughout the product lifecycle. Direct engagement with Nationally Recognized Testing Laboratories (NRTL) on strategies and providing on-site testing support.  Lead worldwide radio certification and market access activities for wireless medical devices, driving successful approvals and compliance maintenance across global markets. Establish and govern external standards surveillance and impact assessment processes, translating evolving regulatory and industry requirements into actionable product and quality system plans. Provide quality engineering leadership for lifecycle compliance activities spanning development, commercialization, sustaining engineering, post-market monitoring, and product change management. Drive cross-functional alignment with Regulatory Affairs, R&D, Clinical, Manufacturing, and external certification agencies to proactively manage compliance risks and support business objectives. Resolving escalations, navigating teams to solutions, and acting as the Quality function decision maker for your respective platforms. Fostering strong, positive, supportive, and collaborative partnerships with your cross-functional peers and leaders. You will be responsible for leading, organizing, developing, and growing an organization of Compliance Engineers while ensuring required levels of quality engineering support are provided to project teams. You will represent the organization during regulatory audits and inquiries.  What makes you successful: You have demonstrated leadership experience in working with NRTL’s on certification strategies for medical devices as well as local regulatory authorities globally regarding earning radio certifications. You demonstrate an ability to adapt to shifting

Listing verified . Applications go through the company's official careers site.

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