About Dexcom:

Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world.

Summary:

Software Quality Assurance Engineer-II to provide support, and active participation in the development, application, and continuous improvement of software engineering best practices used in software development. This position will collaborate closely with many different cross-functional teams spanning Systems Engineering, Product Development, Test Engineering, and other departments, ensuring that these software systems or tools are developed, validated, implemented, and maintained in accordance with internal Software Development Life Cycle (SDLC) processes.

This role is part of a persistent, fully dedicated team focused on creating significant value by driving Dexcom's world-class continuous glucose monitoring (CGM) technology into new applications. These important initiatives, aligned with our enterprise-wide Corporate Strategy, are entrepreneurial by nature, as they may require novel go-to-market strategies, breakthrough clinical evidence, and new technologies. Each member of this team will play a critical role in helping Dexcom first explore then realize the significant potential that exists within these exciting new opportunities and as appropriate facilitate their successful integration into the larger enterprise.

Functional Description: Technical Individual Contributor

Debugs software products through the use of systematic tests to develop, apply, and maintain quality standards for company products. Develops, modifies, and executes software test plans, automated scripts and programs for testing. Analyzes and writes test standards and procedures. Maintains documentation of test results to assist in debugging and modification of software. Analyzes test results to ensure existing functionality and recommends corrective action. Consults with development engineers in resolution of problems. Provides feedback in preparation of technical appraisals of programming languages, systems, and computation software. Ensures quality computer integration into the overall functions of scientific computation, data acquisition, and processing.

Essential Duties & Responsibilities:

• Follow procedures to guide software and systems development and ensure best engineering practice compliance with relevant regulatory requirements


• Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams, including:
  
  
  • Risk Management
  
  
  • Cyber security Risk assessment
  
  
  • Systems Validation
  
  
  • Quality Investigations
  
  
  • Traceability
  
  
  • Software Design
  
  
  
  


• Participate in engineering requirement, design, and testing reviews.


• Track and risk assess Software Anomalies for pre- and post-market medical device software.


• Participate in cybersecurity and other risk management processes (DFMEA, PFMEA, SHA).


• Support internal and external regulatory audits, and other quality assurance functions.


• Define or identify potential compliance gaps and assess new regulations against existing or new software and computer systems.


• Demonstrate understanding of software best practices (C#, Java, big-data technologies and sql technologies, eQMS, continuous integration, automation, test driven development, UX and HF, etc.)


• Assess products and systems to identify defects, abnormalities and design flaws.


• Work with the departments to discuss system gaps, fixes, design solutions and risks.


• Participate in code reviews.


• Participate as a support member of the design team. Activities may include assisting with defining design (software) inputs; designing components and processes; verifying that design outputs satisfy design inputs.


• Participates in process improvements and supports on-going business goals and objectives.


• Perform other duties as assigned.

Required Qualifications

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


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


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


• Ability to interpret software design and code (C/C++/C# or any other object-oriented language) to verify implementation of requirements


• Experience testing at the system level.


• Ability to communicate and present to all levels of management.


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


• Experience working with cloud based systems.

Preferred Qualificaitons

• ASQ Certified Software Quality Engineer (CSQE)


• Cyber Security experience


• Experience working with Cloud based infrastructure and systems that process, store and distribute large sets of data continuously.

Experience and Education Requirements:

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

Travel Required:

• Up to 25%


• Must be capable of working from home

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An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Talent Acquisition at talentacquisition@dexcom.com .

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.