Sr Software QA Engineer

Dexcom; San Diego (CA); On-site; USD 96,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

Dexcom seeks a postmarket investigations professional to partner with Regulatory Affairs, Quality, and R&D in investigating software- and device-related issues. You will drive root-cause analysis, CAPAs, and risk assessments to ensure patient safety and regulatory compliance.

You will apply structured problem-solving, analyze data trends, and translate findings into actionable improvements across product performance and user experience.

Qualifications

• Knowledge of medical device quality systems and regulatory requirements.
• Ability to apply risk-based decision-making per regulatory expectations.
• Experience with software-focused investigations and CAPAs.
• Strong data interpretation and trend analysis skills.

Responsibilities

• Collaborate with Regulatory Affairs, Quality, R&D, and Clinical teams to investigate postmarket issues.
• Lead and document software- and device-related postmarket investigations.
• Develop and maintain software risk assessments and DFMEA/PFMEA alignment.
• Communicate investigation outcomes to stakeholders with clear recommendations.

Skills

Regulatory knowledge

Software risk mgmt

Statistical analysis

Cross-functional collaboration

Technical communication

Education

Bachelor’s in technical field

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:At Dexcom, the Postmarket Investigations team serves as a critical link between real-world product performance and continuous product improvement. As part of the Customer Advocacy organization, we assess postmarket feedback and product data to ensure learnings are integrated into future product enhancements. This role has a direct impact on patient safety, product reliability, and regulatory compliance through partnership with teams across R&D, Quality, and Commercial Operations. Our team values technical excellence, accountability, and continuous learning, while fostering a collaborative and supportive environment. Team members have the unique opportunity to drive quality improvements, influence key business processes, and contribute to technologies that empower people to take control of their health.Where you come in:You will collaborate with cross-functional partners including Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to support the investigation, documentation, and resolution of software- and device-related postmarket issues.You will drive the development and continuous improvement of complaint investigation processes, ensuring alignment with software risk management activities such as hazard analysis, DFMEA, PFMEA, and product risk assessments.You will develop and maintain a deep understanding of Dexcom’s software ecosystem and technical architecture to effectively evaluate product performance, investigate anomalies, and identify opportunities for continuous improvement.You will apply structured problem-solving methodologies and data-driven approaches to conduct investigations, lead engineering studies, and identify root causes using statistical analysis and industry-standard tools.You will analyze, synthesize, and communicate investigation outcomes to technical and non-technical stakeholders, providing clear recommendations and supporting informed decision-making across the organization.You will contribute to postmarket quality processes, including CAPA, Health Hazard Evaluations (HHEs), and other quality system activities, ensuring thorough assessment of product performance and risk.You will perform software-focused risk assessments related to product anomalies, cybersecurity vulnerabilities, emerging technologies, and postmarket trends, helping to ensure product safety, reliability, and regulatory compliance.You will partner with product development and quality teams to translate postmarket insights into actionable improvements, driving enhancements to product performance, user experience, and patient safety.What makes you successful:Demonstrated knowledge of medical device quality systems and regulatory requirements, including FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR, and other applicable global regulations.Experience supporting software quality engineering activities throughout the product lifecycle, including requirements, architecture, design, development, verification, validation, release, and postmarket surveillance.Strong understanding of software risk management principles and methodologies, with the ability to apply risk-based decision-making in alignment with regulatory expectations and industry best practices.Excellent communication and collaboration skills, with the ability to effectively convey complex technical concepts to both technical and non-technical stakeholders across the organization.Working knowledge of modern software technologies, including cloud-based platforms, distributed systems, cybersecurity fundamentals, software architectures, and data-driven applications.Proven ability to apply engineering fundamentals and structured problem-solving techniques to investigate complex issues, determine root causes, and drive effective corrective actions.Strong analytical mindset with experience interpreting data, identifying trends, and translating findings into actionable recommendations.Ability to balance technical depth with business impact, driving decisions that support product quality, patient safety, compliance, and customer experience.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 5-8 years related experience or Master’s degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience .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:$95,900.00 - $159,900.00#DexcomUS