Sr Software Design Qa Engineer

About Dexcom
Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company's inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.
Meet the team:
Dexcom's Software Quality Assurance Team is responsible for various aspects of Quality Engineering, including administration of specific aspects of the quality system. As a Sr Software Quality Assurance Engineer, your job tasks require collaborating with multiple internal Dexcom functions (Quality Assurance, Research & Development, Software Development, Operations, Engineering, Regulatory Affairs, Clinical Affairs, Human Factors, Product Management, Legal, Finance, Customer Operations, Technical Support, and senior management). To succeed in this role, you must be systematic, highly organized, articulate, technical, and able to work in a team environment. A positive attitude is important as Dexcom is a fast-paced atmosphere with constantly shifting priorities.
Where you come in:

• You will NOT execute software testing; this is NOT a test role
• You will ensure product software and software development processes conform to applicable safety and quality system regulations and standards (ex. FDA 21 CFR Part 820, IEC 62304, & ISO 13485)
• You will be responsible for guiding teams in execution of Software Life Cycle and design control activities
• You will lead risk management activities to positively impact the safety and efficacy of products
• You will facilitate teams in identifying, documenting, assessing, correcting, and preventing quality issues using risk analysis and root cause analysis tools, starting with initial product concept to design transfer and post-market surveillance
• You will be responsible for identifying areas of process improvements and driving process improvements activities; including designing, updating, and applying company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations
• You will participate in Cyber security risk assessments
• You will work closely with mobile app teams as a technical quality representative
• As a member of the Design Team, your activities may include assisting with defining design inputs, designing components and processes, and verifying that design outputs satisfy design inputs, all while guiding R&D teams through a risk-based approach to design
• You will participate in health hazard assessments for product field issues

What makes you successful:

• You'll need a minimum of a Bachelor's degree with 6+ years of related experience (advanced degree and 4+ years related experience can substitute); medical device or other regulated industry preferred
• Your Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485
• Your extensive knowledge and experience with SDLC processes along with software development and test methodologies such as Agile Software Development, Waterfall Model, etc.
• Your Software Quality and/or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test
• Your ability to interpret Software Design and code to verify implementation of requirements
• Your ability to work in a hands-on, fast-paced environment, understand complex tasks and goals, and drive projects to completion with limited supervision
• Your proficiency at written and verbal communication skills, including experience with presenting to all levels of management
• An understanding of mobile device operating system software/hardware (applications, internet connection, Bluetooth communication)
• ASQ Certified Software Quality Engineer

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:

• 15-25%

Experience and Education Requirements:

• Typically requires a Bachelor's degree in a technical discipline, and a minimum of 5-8 years related experience or Master's degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com.
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 Dexcom Talent Acquisition at talentacquisition@dexcom.com.
View the OFCCP's Pay Transparency Non Discrimination Provision at this link.
Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true
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.
Salary:
$91,400.00 - $152,300.00