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# Staff Design Quality Engineer

- **Company:** 10 Dexcom (uk) Distribution Limited
- **Location:** United States (Remote available)
- **Experience:** Experienced
- **Salary:** $111,100.0 - $185,100.0
- **Contract:** Permanent contract
- **Skills:** Artificial Intelligence, Systems Engineering
- **Published:** September 15, 2026
- **Apply:** https://startup.jobs/staff-design-quality-engineer-global-expansions-10-dexcom-uk-distribution-li-10067228

## About the Role

* 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, * 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.

## Description

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, To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.

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