Senior Director, Hardware Design Quality & NPI

Dexcom; San Diego (CA); On-site; USD 164,000 - 274,000; Full time

Job summary

Dexcom is seeking a senior Quality leader to drive Design Control, Risk Management and Design Transfer for Advanced Technology and New Product Introduction teams. You will own global Electrical Safety, EMC and Radio certification strategies, while guiding DFSS and other DfX initiatives across platform development.

You will build and lead a team of Design Quality Engineers, partner with cross-functional peers, and represent Dexcom during regulatory audits.

Qualifications

• Bachelor-level engineering degree required.
• Minimum 13 years in medical device development with 8+ years in leadership.
• Strong track record in design controls, risk management, and compliance.

Responsibilities

• Lead as Quality function leader for Dexcom’s Advanced Tech and NPI Core Teams.
• Drive Design Control, Risk Management, and Design Transfer strategies.
• Resolve escalations, make Quality decisions across platforms, and guide cross-functional teams.
• Foster strong partnerships with peers and leaders across the organization.
• Engage in industry standards initiatives, especially Electrical Safety and EMC.
• Lead DFSS and other Design for Excellence initiatives in advanced tech and product development.
• Oversee Electrical Safety, EMC, and Radio certification strategies globally; manage external standards.
• Build and grow a team of Design Quality Engineers and Managers; support platform teams.
• Represent the organization during regulatory audits with clear technical articulation.
• Promote universal understanding and commitment to quality standards and regulatory requirements.

Skills

Design Control leadership

Risk Management

Design Transfer

DFSS

DfX methodologies

Electrical Safety

EMC (IEC 60601-1-2)

Radio Certification

Root Cause Analysis

Project Management (PMBOK/PMP)

Education

Engineering degree

Tools

ISO 14971

IEC 60812

Job description

Dexcom is seeking a senior Quality leader to drive Design Control, Risk Management and Design Transfer for Advanced Technology and New Product Introduction teams. You will own global Electrical Safety, EMC and Radio certification strategies, while guiding DFSS and other DfX initiatives across platform development.

You will build and lead a team of Design Quality Engineers, partner with cross-functional peers, and represent Dexcom during regulatory audits.