Software QA Engineer 2

Meet the team: 

This functional department provides technical support and guidance to the Software teams to ensure conformance to software development process and applicable safety and quality system regulation and standards such as IEC 62304, ISO 13485, ISO 14971, 21 CFR 820. We are responsible for various aspects of Software Design Assurance with focus on product improvement, new product development and defect prevention. We interface with different cross functional groups (Software Engineering, Software Test, Regulatory Affairs, Marketing, Project management, System Engineering, Clinical and others). This team has a great team culture by supporting each other in a fast-paced environment and dealing with shifting priorities with a positive attitude.  

Where you come in:  

• You will actively participate as a core team member of the R&D Quality Assurance Engineering team 

• You will provide guidance on IEC 62304, 21 CFR 820, ISO 14971 and other relevant regulations worldwide to the cross-functional teams 

• You will lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams 

• You will provide technical guidance with respect to equipment, software, product, process requirements and driving risk management deliverables like SHA, design and process FMEA 

• You will provide guidance to Software Design and Test Teams for System validations, Software design verification and traceability, Software configuration management, tool vali‐dations and software integrations.  

• You will support post market activities related to Software anomalies, risk assessments and CAPA activities (if applicable)  

• You are responsible for reviewing, authoring, revising, and approving appropriate technical documentation including design history file, standard operating procedures, protocols, reports, and software design control deliverables 

• You will assess impact of change control to ensure no adverse impact to product performance and a state of compliance is maintained 

• You will effectively communicate with broad Dexcom team and upper-level management on plans, status of tasks, project progress and challenges 

• You will assume and perform other duties as assigned 

What makes you successful:  

• You have experience working with software mobile applications 

• You bring Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971 

• Your knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model 

• Your Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test 

• Your proficiency to interpret software design and code to verify implementation of requirements 

• You have Software development and/or Software test experience. 

• Your ability to understand complex tasks and goals. Drive projects to completion with limited supervision. 

• Your ability to communicate and present to all levels of management 

• Nice to have knowledge of Cyber Security  

• Nice to have ASQ Certified Software Quality Engineer (CSQE) certification or equivalent 

• Nice to have Jama, Jira, Kettryx, and/or Test Rails experience 

What you’ll get: 

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors 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.  

Travel Required: 

• 0-5%