Sr Staff QA Engineer

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 were 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 weve 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. Weve already changed millions of lives and were 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. Well get there by constantly reinventing unique biosensing-technology experiences. Though weve 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 Dexcoms 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.
• Bachelors 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 youll 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 Bachelors degreein a technical discipline and a minimumof 13 years related experience or aMasters degree and 8 yearsequivalent industry experience of a PhDand 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. Dexcoms AAP may be viewed upon request by contacting Talent Acquisition at

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

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: 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.

AI in Hiring Notice:Wemayuse AI supported toolsto help make our hiring process more efficient consistent and accessible for candidates around the hiring decisions are made by people.

Salary:

#DexcomUS