Sr Software QA Engineer Remote - United States Posted 20 hours ago

Dexcom Inc.; Northern (KY); Hybrid; USD 96,000 - 160,000; Full time

Benefits offered by this job

A front row seat to CGM technology

Comprehensive benefits program

Global growth opportunities

Career development programs

Innovative organization

Job summary

Dexcom Inc. seeks a Postmarket Investigations professional to help bridge real-world product performance with continuous improvement. You will investigate software- and device-related postmarket issues, lead root-cause analyses, and drive CAPA and risk assessments across R&D, Quality, and Regulatory teams.

You will apply structured problem-solving, analyze data trends, and communicate findings to technical and non-technical stakeholders to support patient safety and regulatory compliance.

Qualifications

• Knowledge of medical device quality systems and regulatory requirements (FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR)
• Experience in software quality engineering through product lifecycle
• Strong software risk management principles and regulatory-aligned decision-making
• Excellent communication and collaboration across technical and non-technical stakeholders
• Knowledge of cloud-based platforms, distributed systems, cybersecurity, and data-driven apps

Responsibilities

• Collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to investigate postmarket issues
• Develop and improve complaint investigation processes aligned with risk management activities
• Understand Dexcom’s software ecosystem to evaluate product performance and identify improvements
• Apply structured problem-solving and data-driven approaches to investigations and root-cause analysis
• Communicate investigation outcomes to stakeholders with actionable recommendations
• Contribute to postmarket quality processes (CAPA, HHEs, quality system activities)
• Perform software-focused risk assessments on product anomalies and cybersecurity vulnerabilities
• Translate postmarket insights into product and patient-safety improvements

Skills

Medical device quality systems

Regulatory requirements

Software risk management

Data analysis

Cross-functional collaboration

Education

Bachelor’s degree in technical discipline

Master’s degree in technical discipline

PhD (optional)

Job description

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:

• You have 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.
• You have experience supporting software quality engineering activities throughout the product lifecycle, including requirements, architecture, design, development, verification, validation, release, and postmarket surveillance.
• You have 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.
• You have excellent communication and collaboration skills, with the ability to effectively convey complex technical concepts to both technical and non-technical stakeholders across the organization.
• You have working knowledge of modern software technologies, including cloud-based platforms, distributed systems, cybersecurity fundamentals, software architectures, and data-driven applications.
• You have proven ability to apply engineering fundamentals and structured problem-solving techniques to investigate complex issues, determine root causes, and drive effective corrective actions.
• You have strong analytical mindset with experience interpreting data, identifying trends, and translating findings into actionable recommendations.
• You have the 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].

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].

Salary:

$95,900.00 - $159,900.00