Sr SW Design Quality Engineer

Dexcom Corporation 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, unlocking information and insights that drive better health outcomes. 25 years later, we’re still pioneering the industry, broadening our vision beyond diabetes to empower people to take control of health with personalized, actionable insights aimed at solving important health challenges.

Senior Software Design Assurance Engineer (Sr Software Design Quality Engineer) provides technical support and guidance to software teams to ensure conformance to software development processes and applicable safety and quality system regulations and standards (e.g., IEC 62304, ISO 13485, ISO 14971). The role focuses on product improvement, new product development, and defect prevention, and interfaces with cross‑functional groups.

• Actively participates as a core team member of the R&D Quality Assurance Engineering team.
• Strong understanding of, and ability to provide guidance on IEC 62304, 21 CFR 820, and other relevant regulations worldwide.
• Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams, including:
• Drive pre‑market risk management deliverables like SHA, design FMEA and support cyber‑security risk management.
• Provide guidance to software design and test teams, support software configuration management, tool validations, and software integrations.
• Review and approve all software design control deliverables.
• Support post‑market activities related to software anomalies, risk assessments and CAPA activities (if applicable).
• Lead and support R&D software design assurance efforts including continuous improvement opportunities for products and processes.
• Review, author, and revise appropriate technical documentation including design history files, standard operating procedures, protocols, reports, etc.
• Assess the impact of change control to ensure no adverse impact on product performance and a state of compliance is maintained.
• Communicate effectively with the broad Dexcom team and upper‑level management on plans, status of tasks, project progress and challenges.
• Assume and perform other duties as assigned.

• Medical device experience in compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485.
• Knowledge and experience with SDLC processes along with software development methodologies such as Agile and Waterfall.
• Software quality or engineering experience in requirements analysis, design/development, product integration and test.
• Ability to interpret software design and code to verify implementation of requirements.
• Software development and/or software test experience.
• Ability to communicate and present to all levels of management.
• Ability to understand complex tasks and goals; drive projects to completion with limited supervision.
• Experience working with cloud‑based systems.

• ASQ Certified Software Quality Engineer (CSQE).
• Cyber‑security experience.
• Experience working with cloud‑based infrastructure and systems that process, store and distribute large sets of data continuously.

• A front‑row seat to life‑changing CGM technology and our 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.

Typically requires a Bachelor’s degree in a technical discipline and a minimum of 5–8 years related experience, or a Master’s degree and 2–5 years equivalent industry experience, or a PhD and 0–2 years experience.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

$95,900.00 - $