Sr Staff QA Engineer

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 serve as the Design Quality Engineering subject matter expert for material characterization, formulation science, and material-related risk management activities across advanced technology, new product development, and lifecycle management programs.

• Lead quality oversight of characterization and qualification strategies for raw materials, intermediates, formulations, and finished materials, with a focus on polymers, enzymes, reagents, adhesives, coatings, membranes, and other critical material systems.
• Establish clear traceability between material attributes, formulation characteristics, manufacturing processes, design inputs, and finished device safety, performance, and user needs.
• Partner closely with R&D, Materials Science, Analytical Chemistry, Process Development, Manufacturing, and Regulatory Affairs teams to ensure material and formulation decisions are supported by robust scientific evidence and quality engineering principles.
• Drive risk-based decision making through application of ISO 14971 risk management, ensuring material-related hazards, failure modes, and variability are appropriately identified, evaluated, controlled, and verified.
• Provide Design Quality leadership for characterization studies, analytical method assessments, stability programs, material compatibility evaluations, and verification activities that demonstrate product safety and essential performance.
• Represent Design Quality during design reviews, audits, inspections, and regulatory submissions, clearly communicating the linkage between material characterization, risk controls, and finished device performance.

What makes you successful

• Deep technical expertise in material characterization, analytical chemistry, formulation development, or material science within the medical device, IVD, biotechnology, combination product, or pharmaceutical industries.
• Demonstrated experience characterizing and qualifying complex material systems, including polymers, enzymes, biological reagents, sensor chemistries, adhesives, coatings, or other critical materials used in regulated products.
• Strong understanding of how raw material, intermediate, and formulation characteristics influence finished device safety, effectiveness, reliability, and essential performance.
• Proven experience applying ISO 14971 risk management principles to establish and maintain traceability between material attributes, critical quality attributes, and product-level risks.
• Experience supporting Design Controls, verification and validation activities, design transfer, and regulatory submissions in a regulated environment.
• Skilled in reviewing and interpreting analytical, chemical, physical, biological, and statistical data to make sound, risk-based quality decisions.
• Excellent cross-functional collaboration, communication, and influencing skills and effective working in highly technical, multidisciplinary teams.
• Minimum of 8 years of experience in medical device, pharmaceutical, biotechnology, or combination product development and quality engineering roles.
• Bachelor's degree in Chemistry, Chemical Engineering, Materials Science, Polymer Science, Biochemistry, Biomedical Engineering, Pharmaceutical Sciences, or a related technical discipline required; advanced degree (MS or PhD) preferred.

Experience and Education Requirements

Typically requires a Bachelor's degree in a technical discipline, and a minimum of 13+ years related experience or a Master's degree and 8+ years equivalent industry experience or a PhD and 5+ years of experience.

Flex Workplace

Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).