Sr SW Design Quality Engineer

1 DexCom Inc

San Diego, California, United States

San Diego, California, United States

Über

About the Role
The Senior Software Design Assurance (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 such as IEC 62304, ISO 13485, and ISO 14971. This role focuses on product improvement, new product development, and defect prevention within Dexcom’s R&D Quality Assurance Engineering team. Responsibilities
Actively participate as a core team member of the R&D Quality Assurance Engineering team. 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 software hazard analysis, 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. Lead and support R&D software design assurance efforts including continuous improvement opportunities for products and processes. Review, author, and revise technical documentation including design history files, standard operating procedures, protocols, and reports. Assess the impact of change control to ensure no adverse impact on product performance and maintain compliance. Effectively communicate with the 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, and 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. Excellent communication and presentation skills at all levels of management. Strong analytical and problem‑solving skills, capable of handling complex tasks and goals. Project management skills to drive projects to completion with limited supervision. Experience working with cloud‑based systems. Preferred Requirements
ASQ Certified Software Quality Engineer (CSQE). Cyber‑security experience. Experience with cloud‑based infrastructure and systems that process, store, and distribute large sets of data continuously. Education Requirements
Bachelor’s degree in a technical discipline with 5–8 years of related experience, or Master’s degree with 2–5 years of equivalent industry experience, or PhD with 0–2 years of experience. Compensation
Salary range: $95,900.00 – $159,900.00. Benefits
A front‑row seat to life‑changing CGM technology. Learning opportunities within the Dexcom warriors community. A full and comprehensive benefits program. Global growth opportunities. Career development through in‑house learning programs and/or qualified tuition reimbursement. 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, protected veteran status, or disability status. Dexcom provides reasonable accommodations to enable individuals with disabilities to perform essential functions of the job.
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San Diego, California, United States

Sprachkenntnisse

English

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