Sr. Manager, Design Quality Engineering - Product Compliance

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.

• 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 priorities and manage multiple initiatives.
• You possess exceptional interpersonal, written, and verbal communication skills.
• You are self-motivated with a collaborative, proactive, and accountable approach.
• Bachelors degree in Engineering preferred.

Experience and Education Requirements

• Typically requires a Bachelor’s degree with 13+ years of industry experience
• Requires a degree in a technical discipline
• 5-8 years of previous people management experience

Flex Workplace

Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).