Sr Staff QA Engineer

Dexcom•San Diego, CA

2d•$128,600 - $214,400•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 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. You will 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. You will establish clear traceability between material attributes, formulation characteristics, manufacturing processes, design inputs, and finished device safety, performance, and user needs. You will 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. You will 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. You will 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. You will represent Design Quality during design reviews, audits, inspections, and regulatory submissions, clearly communicating the linkage between material characterization, risk controls, and finished device performance.

Requirements

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 are effective working in highly technical, multidisciplinary teams.
A 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.

Nice To Haves

Advanced degree (MS or PhD) preferred.

Responsibilities

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.