Staff Design Quality Engineer (Global Expansions)

Dexcom; California (MO); Remote; USD 111,000 - 185,000; Full time

Benefits offered by this job

Full benefits program

Growth opportunities

Remote work option

Job summary

Qualifications

• Minimum 8+ years in medical device development.
• 5+ years leading and implementing global expansions in medical device development.
• Experience aligning DHFs with global regulatory requirements (FDA, EU MDR, ISO standards).

Responsibilities

• Align Design History Files with regulatory requirements for international markets.
• Lead quality assessments of change controls, CAPA, and non-conformances.
• Serve as primary Quality contact for regulatory inquiries in global expansions.
• Investigate CAPA and complaint investigations and drive corrective actions.
• Identify, prioritize and resolve quality issues across programs.

Skills

Design Quality Eng

Regulatory Compliance

Risk Management

CAPA & NCR

DHFs Alignment

Global Expansions

Cross-functional Lead

Education

Bachelor's degree in technical discipline

Master's degree preferred

Job description

The CompanyDexcom 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 Staff Design Quality Engineer (Global Expansions) serves as the principal technical authority for design control, product risk management, and regulatory compliance across international markets. This role is vital for driving the regional adaptation, platform expansion, and localization of new and existing products. The ideal candidate ensures that local design requirements are fully integrated into our global product development lifecycl eWorking cross-functionally with Systems Engineering, Design Engineering, Clinical, Regulatory Affairs, Quality, Manufacturing, Human Factors, and Post-Market Surveillance, this role integrates global medical device regulations – including FDA 21 CFR Part 820 /QMSR, ISO 13485, EU MDR, ISO 14971 etc - into product development while ensuring patient safety and regulatory compliance .Where you come in :You will serve as the subject matter expert (SME) responsible for aligning Design History Files (DHFs) with the compliance requirements of target international marketsYou will act as the core team lead Quality Lead responsible for assessing the impact of change controls, CAPA’s and Non Conformance’s on the overall systemYou will serve as the lead Quality contact for requests from regulatory agencies as part of global expansionsYou will act as the Quality Lead responsible for supporting investigations from CAPA’s and complaint investigationsYou will serve as the Quality Lead responsible for identifying , prioritizing, communicating, and resolving quality issuesWhat makes you successful :You have proven experience in Design Quality Engineering and Assurance within the medical device industry.You must have a minimum of 8+ years of experience in medical device development.You bring at least 5+ years in leading and implementing global expansions in medical device developmentYou demonstrate an ability to collaborate with cross functional teams.You possess exceptional interpersonal, written, and verbal communication skills.You are self-motivated with a collaborative, proactive, and accountable approachWhat you’ll get :A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community .A full and c omprehensive benefit s progra m .Growth opportunities on a global scale.Access to career development through in-house learning programs and/or qualified tuition reimbursemen t.An exciting and innovative , industry - leading organization committed to our employees , customers , and the communities we serve .Travel Required:5-15%Experience and Education Requirements:Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 8-12 years related experience or Master’s degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.Remote Workplace : Your location will be a home office; y ou are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option .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] 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], 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=trueTo 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:$111,100.00 - $185,100.00#DexcomUS