Sr. Manager, Design Quality Engineering - Product Compliance

Dexcom hires a Senior Manager to lead design quality engineering and product compliance for its continuous glucose monitoring products. The role owns electrical safety, EMC, and radio certification strategy across the product lifecycle, while leading compliance engineers and partnering across functions to manage risks and support regulatory audits.

Responsibilities:

• 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

Requirements:

• 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
• 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
• Bachelors degree in Engineering preferred