Software QA Engineer 2

The Company Dexcom Corporation (NASDAQ DXCM) 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. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.   We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. 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