Staff Design Quality Engineer – Global Expansions

🔥 13 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $111.1k - $185.1k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Dexcom

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Dexcom is a leading provider of continuous glucose monitoring (CGM) systems, revolutionizing how people manage diabetes and track their glucose levels. Known for their best-in-class glucose biosensing technology, Dexcom offers products like the Dexcom G7 CGM system, which provides real-time glucose monitoring and insights to help individuals become healthier. Founded in 1999, Dexcom has consistently innovated in the field of diabetes management, empowering users to take control of their health with accurate and advanced glucose monitoring solutions. Their products are designed for both adults and children and do not require a prescription.

📋 Description

• Serve as the principal technical authority for design control, product risk management, and regulatory compliance across international markets • Drive regional adaptation, platform expansion, and localization of new and existing products • Integrate local design requirements into the global product development lifecycle • Work cross-functionally with Systems Engineering, Design Engineering, Clinical, Regulatory Affairs, Quality, Manufacturing, Human Factors, and Post-Market Surveillance • Serve as the SME aligning Design History Files with compliance requirements of target international markets • Lead quality assessments of the impact of change controls, CAPAs, and nonconformances on the overall system • Serve as the lead Quality contact for regulatory agency requests related to global expansions • Support CAPA and complaint investigations • Identify, prioritize, communicate, and resolve quality issues

🎯 Requirements

• Proven experience in Design Quality Engineering and Assurance within the medical device industry • Minimum of 8+ years of experience in medical device development • At least 5+ years leading and implementing global expansions in medical device development • Typically requires a Bachelor’s degree in a technical discipline and 8–12 years of related experience, or a Master’s degree and 5–7 years of equivalent industry experience, or a PhD and 2–4 years of experience • Knowledge of design control, product risk management, and regulatory compliance • Knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, and ISO 14971 • Ability to collaborate with cross-functional teams • Exceptional interpersonal, written, and verbal communication skills • Self-motivated with a collaborative, proactive, and accountable approach • Travel required: 5–15%

🏖️ Benefits

• A full and comprehensive benefits program • Growth opportunities on a global scale • Career development through in-house learning programs and/or qualified tuition reimbursement • Home office workplace • Flex workplace option may be available for employees within commuting distance of a Dexcom site