Sr SW Design Quality Engineer

Job Title : Senior Software Design Assurance Engineer Responsibilities 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 the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams. Drive pre‑market risk management deliverables such as SHA, design FMEA, and support cybersecurity 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. Responsible for reviewing, authoring, and revising appropriate technical documentation including design history files, SOPs, protocols, reports, etc. Assess the impact of change control to ensure no adverse impact on product performance and maintain compliance. Effectively communicate 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. Qualifications Medical Device experience in compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485. Knowledge and experience with SDLC processes and 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 drive projects to completion with limited supervision. Experience working with cloud-based systems. Preferred Requirements ASQ Certified Software Quality Engineer (CSQE). Cybersecurity experience. Experience with cloud-based infrastructure and systems that process, store, and distribute large sets of data continuously. Experience and Education Requirements 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 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 View email address on click.appcast.io. For individuals with a disability who would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at View email address on click.appcast.io. #J-18808-Ljbffr Dexcom Inc.