Sr SW QA Engineer
Istituto Marangoni - San Diego, CA
posted 6 months ago
About the position
Dexcom, Inc. is a leader in Continuous Glucose Monitoring (CGM) systems, dedicated to transforming diabetes care and management. The company focuses on providing best-in-class solutions that empower patients and healthcare professionals to better manage diabetes. As part of the R&D Quality Assurance Engineering team, you will play a crucial role in ensuring compliance with software development processes and applicable safety and quality system regulations, such as IEC 62304, ISO 13485, and ISO 14971. This position is not a testing role but rather involves providing technical support and guidance to software teams, ensuring that all software development and validation activities meet regulatory requirements and internal standards. In this role, you will actively participate as a core team member, leading the effective application and continuous improvement of policies, procedures, and practices related to software development. You will provide technical guidance on equipment, software, product, and process requirements, driving risk management deliverables such as Software Hazard Analysis (SHA) and Failure Mode and Effects Analysis (FMEA). Your responsibilities will also include supporting software design verification, traceability, configuration management, and tool validations. Additionally, you will be involved in post-market activities related to software anomalies, risk assessments, and Corrective and Preventive Actions (CAPA) as applicable. You will be responsible for reviewing, authoring, revising, and approving technical documentation, including design history files, standard operating procedures, protocols, reports, and software design control deliverables. Effective communication with the broader Dexcom team and upper management regarding project plans, status, and challenges will be essential. This position requires a proactive approach to drive projects to completion with limited supervision, ensuring that compliance and product performance are maintained throughout the software development lifecycle.
Responsibilities
- Provide guidance on IEC 62304, 21 CFR 820, and other relevant regulations to cross-functional teams.
- Lead the application, compliance, and continuous improvement of software development policies and procedures.
- Provide technical guidance on equipment, software, product, and process requirements.
- Drive risk management deliverables like Software Hazard Analysis (SHA) and FMEA.
- Support Software Design and Test Teams for system validations and software design verification.
- Review, author, revise, and approve technical documentation including design history files and standard operating procedures.
- Assess impact of change control to ensure compliance and product performance.
- Communicate effectively with the Dexcom team and upper management regarding project status and challenges.
Requirements
- Bachelor's degree in a technical discipline with 5-8 years of related experience, or a Master's degree with 2-5 years of equivalent industry experience, or a PhD with 0-2 years of experience.
- Experience working with software mobile applications.
- Medical Device experience in compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485.
- Knowledge of SDLC processes and software development methodologies such as Agile and Waterfall.
- Experience in Software Quality or Engineering, including Requirements Analysis, Design/Development, Product Integration, and Testing.
- Proficiency in interpreting software design and code to verify implementation of requirements.
- Experience with web APIs and software development or testing.
Nice-to-haves
- Cyber Security experience.
- ASQ Certified Software Quality Engineer (CSQE) certification.
Benefits
- Comprehensive benefits program.
- Growth opportunities on a global scale.
- Access to career development through in-house learning programs and qualified tuition reimbursement.
- Innovative and industry-leading organization committed to employees, customers, and communities.
