Staff Design Quality Engineer (Global Expansions)

1 DexCom Inc; California (MO); Hybrid; USD 111,000 - 185,000; Full time

Benefits offered by this job

Benefits program

Global growth opportunities

Tuition reimbursement

Job summary

Dexcom is seeking a Staff Design Quality Engineer (Global Expansions) to serve as the principal technical authority for design control, risk management and regulatory compliance across international markets. You will lead DHF alignment, CAPA impact assessments, and act as Quality Lead for regulatory requests.

Requirements include 8+ years in medical device development, 5+ years leading global expansions, strong cross-functional collaboration, and willingness to travel 5–15%.

Qualifications

• Minimum 8+ years in medical device development.
• 5+ years leading and implementing global expansions in medical device development.
• Strong cross-functional collaboration and communication skills.

Responsibilities

• Align Design History Files (DHF) with international market compliance.
• Lead Quality Lead for change controls, CAPA and non-conformances impact assessment.
• Serve as quality contact for regulatory agencies in global expansions.
• Support investigations from CAPAs and complaint investigations and resolve quality issues.

Skills

Design quality engineering

Regulatory compliance

Cross-functional collaboration

Communication skills

Leadership

Education

Bachelor's degree in technical discipline

Master's degree in technical discipline

PhD in related field

Job description

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 Staff Design Quality Engineer (Global Expansions) serves as the principal technical authority for design control, product risk management, and regulatory compliance across international markets. This role is vital for driving the regional adaptation, platform expansion, and localization of new and existing products. The ideal candidate ensures that local design requirements are fully integrated into our global product development lifecycle Working cross-functionally with Systems Engineering, Design Engineering, Clinical, Regulatory Affairs, Quality, Manufacturing, Human Factors, and Post-Market Surveillance, this role integrates global medical device regulations – including FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, ISO 14971 etc - into product development while ensuring patient safety and regulatory compliance.

Where you come in:

You will serve as the subject matter expert (SME) responsible for aligning Design History Files (DHFs) with the compliance requirements of target international markets. You will act as the core team lead Quality Lead responsible for assessing the impact of change controls, CAPA’s and Non Conformance’s on the overall system. You will serve as the lead Quality contact for requests from regulatory agencies as part of global expansions. You will act as the Quality Lead responsible for supporting investigations from CAPA’s and complaint investigations. You will serve as the Quality Lead responsible for identifying, prioritizing, communicating, and resolving quality issues.

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 8+ years of experience in medical device development. You bring at least 5+ years in leading and implementing global expansions in medical device development. You demonstrate an ability to collaborate with cross functional teams. 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.

Travel Required:

5-15%

Experience and Education Requirements:

Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 8-12 years related experience or Master’s degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.

Remote Workplace:

Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.

Please note: The information contained herein is not intended to be an all‑inclusive list of the duties and responsibilities of the job, nor are they intended to be an all‑inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [e-mail]. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [e-mail].

Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true

AI in Hiring Notice:

We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.

Salary: $111,100.00 - $185,100.00 #DexcomUS

Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide. At Dexcom, we're more than just a medical device company; we're a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.