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 talentacquisition@dexcom.com.
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 talentacquisition@dexcom.com.
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
To 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: 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
