Director, Design Quality Engineering - Platform

Dexcom • San Diego, CA

6d • Remote

About The Position

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 on market Product Sustaining Teams. This includes: Acting as the leader on Dexcom Platform Core Teams representing the Quality function Supporting strategy, resourcing, execution, and delivery of Dexcom Platform Core Team commitments associated with Design Changes, Supply Continuity, Global Expansions, and Issue Resolution in alignment with DfX, Design Controls, SDLC, Risk Management, CAPA, and HHE expectations. Managing escalations, navigating to solutions, and acting as the Quality function decision maker for your respective platforms- including shifting resources between Platforms when appropriate and influencing your cross functional peers and leaders. Post Market Risk Management leadership You will act as the Quality lead for Product Remediation Planning and Activities driven through CAPA or Quality Improvement Plans at Dexcom. You will be responsible for leading, developing, and growing an organization of Design Quality Engineers and Managers while ensuring required levels of quality engineering support are provided to Platform teams. You will represent the organization during regulatory audits and inquiries, clearly articulating technical details of product design, design controls, risk management, and issue resolution through CAPA and HHE as applicable. You will promote cross-functional understanding and adherence to quality standards, quality processes, and regulatory requirements. What makes you successful: You have proven experience in Design Quality Engineering and Assurance within the medical device industry. You must have a minimum of 10 years of experience in medical device development. You bring at least 5 years in progressively responsible leadership roles. 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. What you’ll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. 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. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

Requirements

• Proven experience in Design Quality Engineering and Assurance within the medical device industry.
• Minimum of 10 years of experience in medical device development.
• At least 5 years in progressively responsible leadership roles.
• 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.
• 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

Responsibilities

• Acting as the leader on Dexcom Platform Core Teams representing the Quality function
• Supporting strategy, resourcing, execution, and delivery of Dexcom Platform Core Team commitments associated with Design Changes, Supply Continuity, Global Expansions, and Issue Resolution in alignment with DfX, Design Controls, SDLC, Risk Management, CAPA, and HHE expectations.
• Managing escalations, navigating to solutions, and acting as the Quality function decision maker for your respective platforms- including shifting resources between Platforms when appropriate and influencing your cross functional peers and leaders.
• Post Market Risk Management leadership
• Acting as the Quality lead for Product Remediation Planning and Activities driven through CAPA or Quality Improvement Plans at Dexcom.
• Responsible for leading, developing, and growing an organization of Design Quality Engineers and Managers while ensuring required levels of quality engineering support are provided to Platform teams.
• Represent the organization during regulatory audits and inquiries, clearly articulating technical details of product design, design controls, risk management, and issue resolution through CAPA and HHE as applicable.
• Promote cross-functional understanding and adherence to quality standards, quality processes, and regulatory requirements.

Benefits

• A front row seat to life changing CGM technology.
• Learn about our brave #dexcomwarriors community.
• 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.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

What This Job Offers

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