Sr Manager SW Design Quality Engineering

Dexcom Inc.; San Diego (CA); Hybrid; USD 149,000 - 248,300; Full time

Benefits offered by this job

Comprehensive benefits program

Career development opportunities

Work-from-home flexibility

Job summary

Dexcom Inc. is seeking a Senior Manager for Software Quality Engineering in San Diego, CA. This role requires expertise in leading QA teams and ensuring compliance with US and international standards. Responsibilities include oversight of the software development lifecycle, quality metrics, and risk management.

The ideal candidate will have extensive experience in medical device software quality assurance, strong leadership skills, and a Bachelor's degree in a related field. Competitive salary and benefits offered with opportunities for growth.

Qualifications

• 7+ years in software QA or development for medical devices, including 5 years leading teams.
• Experience in Agile environments with knowledge of regulatory standards.
• Ability to lead compliance in fast-paced, regulated settings.

Responsibilities

• Align technology solutions with business objectives and ensure regulatory compliance.
• Manage software development lifecycle and define performance metrics.
• Oversee documentation and reporting of quality findings to management.

Skills

Software QA management

Agile methodologies

Regulatory compliance (IEC 62304, FDA)

Documentation

Team leadership

Education

Bachelor’s degree in engineering or STEM discipline

Tools

Automated testing tools

Cloud platforms (Azure, AWS, Google Cloud)

Job description

Job Description

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, the position oversees the partnerships component of the Quality Management System (QMS) and leads a dedicated team for that function.

Responsibilities

• 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.

Qualifications

• At least 7 years in software QA or development for medical devices, including 5 years leading high‑performing teams.
• Experience in Agile environments with strong knowledge of automated testing and regulatory standards like IEC 62304 and FDA guidance.
• Leadership experience in managing teams, processes, and compliance in a fast‑paced, regulated setting.
• Deep understanding of Quality, Regulatory, and R&D systems within medical devices or other highly regulated industries.
• Strong communication, stakeholder management, and presentation skills.
• Ability to analyze business processes, design improvements, and empower users through training.
• Excellent documentation and presentation skills with the ability to simplify complex strategies.
• Positive, results‑driven, collaborative team player.
• Embrace innovation; ability to learn quickly, adapt to new technologies, and juggle multiple projects.
• 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.

Benefits

• Front‑row seat to life‑changing CGM technology.
• Full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Career development through in‑house learning programs and tuition reimbursement.
• Innovative, industry‑leading organization committed to employees, customers, and communities.

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.

Work Location

Work primarily from a home office. No assigned workstation. Must live within commuting distance of the assigned Dexcom site (typically 75 miles/120km).

Travel

0‑5% travel required.

Equal Opportunity Employer

Dexcom is 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.