Software QA Engineer 2

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 uniquebiosensing-technologyexperiences. 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.

This functional department provides technical support and guidance to Software teams to ensure conformance to software development process and other applicable safety and quality system regulation and standards (e.g.IEC 62304, ISO 13485, ISO 14971). Weare responsible forvarious aspects of Software Design Assurance withfocuson product improvement, new product development and defect prevention. Weinterfacewith different cross functional groups (Software Engineering, Software Test, Regulatory Affairs, Marketing, Project managers, Systems Engineering and others). This team hasa great teamculture supporting each other in a fast-paced environment and dealing with shifting priorities with a positive attitude.

• You will activelyparticipateas a core team member of the R&D Quality Assurance Engineering team.

You will activelyparticipateas a core team member of the R&D Quality Assurance Engineering team.

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

You will provide guidance on IEC 62304, 21 CFR 820, 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 lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams.

• You willprovidetechnical guidance with respect to equipment, software, product, process requirements and driving risk management deliverables like SHA,designand process FMEA.

You willprovidetechnical guidance with respect to equipment, software, product, process requirements and driving risk management deliverables like SHA,designand process FMEA.

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

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

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

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

• Youare responsible forreviewing, authoring, revising, and approvingappropriate technicaldocumentation including design historyfile, standard operating procedures, protocols, reports, and software design control deliverables.

Youare responsible forreviewing, authoring, revising, and approvingappropriate technicaldocumentation including design historyfile, standard operating procedures, protocols, reports, and software design control deliverables.

• You will assessimpactof change control to ensure no adverse impact to product performance and a state of compliance ismaintained.

You will assessimpactof change control to ensure no adverse impact to product performance and a state of compliance ismaintained.

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

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.

You will assume and perform other duties as assigned.

• You have experience working withsoftware mobileapplications.

You have experience working withsoftware mobileapplications.

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

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

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

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

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

YouhaveSoftware Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test.

• Yourproficiencyto interpretsoftware design and code to verify implementation of requirements.

Yourproficiencyto interpretsoftware design and code to verify implementation of requirements.

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

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

• You have experience with web APIs.

You have experience with web APIs.

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

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

• Nice to have Cyber Security experience

Nice to have Cyber Security experience

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

Nice to have ASQ Certified Software Quality Engineer (CSQE) certification.

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

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

• A full and comprehensive benefits program.

A full and comprehensive benefits program.

• Growth opportunities on a global scale.

Growth opportunities on a global scale.

• Access to career development through in-house learning programs and/or qualified tuition reimbursement.

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.

An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

• 0 - 15%

0 - 15%

• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 2-5 years related experience or Master’s degree and 0-2years’ equivalentexperience.

Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 2-5 years related experience or Master’s degree and 0-2years’ equivalentexperience.