Sr Manager SW Design Quality Engineering

RXinsider LTD.; San Diego (CA); Hybrid; USD 149,000 - 248,000; Full time

Benefits offered by this job

Comprehensive benefits

Global growth opportunities

Career development

Tuition reimbursement

Job summary

Dexcom is seeking a Senior Manager, Software Quality Engineering to lead QA across development, testing, and release of medical device software and supporting infrastructure. You will mentor teams, collaborate with regulatory, R&D, cybersecurity, and operations, and ensure compliance with IEC 62304 and FDA guidance while driving continuous improvement.

This flex/hybrid role requires residency in the Pacific Time Zone and a proven track record in regulated environments.

Qualifications

• Bachelor’s degree in Engineering or STEM with 13+ years of experience.
• 5–8 years of people management experience.
• Experience with IEC 62304, FDA guidance and cybersecurity.

Responsibilities

• Lead software QA across the SDLC and coordinate with cross‑functional teams.
• Mentor the QA and partnerships teams to ensure compliant releases.
• Ensure regulatory compliance (IEC 62304, FDA) and audit readiness.
• Present validation records and findings to leadership.

Skills

QA for medical devices

Team leadership

Agile

IEC 62304

FDA guidance

Education

Bachelor’s degree in Engineering or STEM

Tools

Cloud platforms (Azure/AWS/Google)

Big data tools

Mobile/wearable software

Job description

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 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.

Job Description

• This is a flex/hybrid role / Must live in Pacific Time Zone

Meet The Team

The Senior Manager, Software Quality Engineering is responsible for leading all aspects of software quality assurance, including managing and mentoring the QA team. This role works closely with cross-functional teams to ensure that the development, testing, and release of product software and supporting infrastructure comply with U.S. and international regulatory standards. Additionally, this position oversees the partnerships component of the Quality Management System (QMS) and leads a dedicated team for that function.

Where You Come In

• Leadership & Team Management: Align technology solutions with business objectives, ensure regulatory compliance, and provide mentorship to the Software QA and partnerships teams.


• Quality Oversight: Manage the software development lifecycle (SDLC) and define key performance metrics for reporting to senior leadership.


• Compliance & Standards: Ensure compliance with IEC 62304, FDA software validation principles, and cybersecurity guidance throughout the development process.


• Documentation & Reporting: Prepare and present quality findings to executive management and R&D leadership; monitor and resolve ongoing issues.


• Process Improvement: Collaborate with R&D, Operations, CyberSecurity, and V&V teams to maintain efficient, compliant development and testing processes.


• Risk Management: Lead risk assessments, health Hazard assessments and guide mitigation strategies. Also support CAPAs as applicable.


• Regulatory Support: Maintain validated states, review change control documentation, and present validation records during audits. Promote best practices in system design and development.


• Design & Development Support: Participate in design reviews, assist with defining software inputs, and verify outputs against requirements.


• Continuous Improvement: Identify compliance gaps, evaluate new regulations, and update procedures in collaboration with relevant departments. Support organization-wide remediation efforts related to regulatory findings.


• Other Duties: Perform additional responsibilities as assigned.

What Makes You Successful

• Bring your expertise to the forefront with at least 7 years in software QA or development for medical devices, including 5 years leading high-performing teams


• Thrive in Agile environments with strong knowledge of automated testing and regulatory standards like IEC 62304 and FDA guidance


• Leads with confidence, manage teams, processes, and compliance in a fast-paced, regulated setting


• Apply your deep understanding of Quality, Regulatory, and R&D systems within medical devices or other highly regulated industries


• Communicate with impact, strong leadership and stakeholder management skills are essential


• Drive change by analyzing business processes, designing improvements, and empowering users through training


• Craft clear, compelling documentation and presentations that make complex strategies and technical concepts easy to understand


• Be a positive, results-driven team player who brings logic and collaboration to every challenge


• Embrace innovation- Ability to learn quickly, adapt to new technologies and juggle multiple projects with ease


• Work independently while meeting deadlines and delivering exceptional results

Preferred Qualifications

• Proficiency in modern programming languages.


• Experience with cloud platforms (Azure, AWS, Google Cloud) and big data tools.


• Familiarity with mobile and wearable software development.


• Expertise in FDA regulations (21 CFR Part 11 & 820) and cybersecurity guidance.


• BI/AI Platform Experience is a plus


• Experience with Mobile application development

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.

Experience And Education Requirements

• Typically requires a Bachelor’s degree, preferably in an Engineering or STEM discipline, with 13+ years of industry experience


• 5-8 years of previous people management 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).

Travel Required

• 0-5%

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

$149,000.00 - $248,300.00