Sr Staff QA Engineer

RXinsider LTD.; Northern, San Diego (KY, CA); Hybrid; USD 129,000 - 214,000; Full time

Benefits offered by this job

Comprehensive benefits program

Global growth opportunities

Career development programs

Innovative, industry-leading culture

Job summary

Dexcom Corporation is seeking a Design Quality Engineer to lead material characterization and risk management across advanced CGM product development. You will drive evidence-based decisions and ensure traceability between material attributes and device performance.

The role requires extensive experience in characterization, analytical chemistry, and formulation science within medical devices, with emphasis on ISO 14971 and regulatory submissions. Hybrid work with a global, innovative team.

Qualifications

• Bachelor’s degree in a technical discipline with 13+ years of related experience, or Master’s with 8+ years (PhD + 5+ years).
• Experience in medical device, pharmaceutical, biotechnology, or combination product development and quality engineering.
• Strong knowledge of ISO 14971 risk management and design controls.

Responsibilities

• Serve as the Design Quality Engineering SME for material characterization and risk management.
• Lead quality oversight of characterization and qualification strategies for raw materials, intermediates, formulations, and finished materials.
• Establish traceability between material attributes, formulation characteristics, manufacturing processes, design inputs, and finished device safety and performance.
• Partner with R&D, Materials Science, Analytical Chemistry, Process Development, Manufacturing, and Regulatory to ensure decisions are supported by evidence and quality principles.
• Drive risk-based decision making through ISO 14971 risk management, ensuring hazards, failure modes, and variability are identified and controlled.
• Provide Design Quality leadership for characterization studies, analytical method assessments, stability programs, material compatibility evaluations, and verification activities.
• Represent Design Quality during design reviews, audits, inspections, and regulatory submissions.

Skills

Material characterization

Analytical chemistry

Formulation development

Material science

ISO 14971

Design Controls

Regulatory submissions

Cross-functional collaboration

Data interpretation

Education

Bachelor's degree in Chemistry, Chemical Engineering, Materials Science, Polymer Science, Biochemistry, Biomedical Engineering, Pharmaceutical Sciences, or related field

MS or PhD preferred

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 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.

What Makes You Successful

• You have deep technical expertise in material characterization, analytical chemistry, formulation development, or material science within the medical device, IVD, biotechnology, combination product, or pharmaceutical industries.


• You have 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.


• You have a strong understanding of how raw material, intermediate, and formulation characteristics influence finished device safety, effectiveness, reliability, and essential performance.


• You have proven experience applying ISO 14971 risk management principles to establish and maintain traceability between material attributes, critical quality attributes, and product-level risks.


• You have experience supporting Design Controls, verification and validation activities, design transfer, and regulatory submissions in a regulated environment.


• You are skilled in reviewing and interpreting analytical, chemical, physical, biological, and statistical data to make sound, risk-based quality decisions.


• You demonstrate excellent cross-functional collaboration, communication, and influencing skills and are effective working in highly technical, multidisciplinary teams.


• You have 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; advanced degree (MS or PhD) preferred.

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

• 0-5%

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 of 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).

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

$128,600.00 - $214,400.00

#DexcomUS