Sr. Manager, Design Quality Engineering - Product Compliance

Dexcom • San Diego, CA

1d • $141,800 - $236,400 • Remote

About The Position

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.

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

• 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.
• Ability to adapt to shifting priorities and manage multiple initiatives.
• Exceptional interpersonal, written, and verbal communication skills.
• Self-motivated with a collaborative, proactive, and accountable approach.
• Bachelor’s degree in Engineering preferred.
• Bachelor’s degree with 13+ years of industry experience
• Degree in a technical discipline
• 5-8 years of previous people management experience

Responsibilities

• 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.
• Leading, organizing, developing, and growing an organization of Compliance Engineers while ensuring required levels of quality engineering support are provided to project teams.
• Represent the organization during regulatory audits and inquiries.

Benefits

• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager