Senior Software Design Assurance (Sr Software Design Quality) Engineer

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 were 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 weve 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. Weve already changed millions of lives and were 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. Well get there by constantly reinventing unique biosensing-technology experiences. Though weve 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 is NOT a test role*

The Senior Software Design Assurance (Sr Software Design Quality) Engineer 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).

This role will be responsible for various aspects of Software Design Assurance with a focus on product improvement new product development and defect prevention. This position will interface with different cross functional groups (Software Engineering Software Test Regulatory Affairs Marketing Project

managers Systems Engineering Cybersecurity and others). A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.

*This is NOT a test role*

Where you come in:

• You will actively participate as a core member of the R&D Quality Assurance Engineering team supporting software design assurance for cloudbased data platform and AI/MLenabled systems.

• You will provide handson technical guidance to crossfunctional teams on IECCFR 820 and other applicable global regulations for softwareasaservice data and AIdriven products.

• You will lead the effective application compliance and continuous improvement of software development and validation practices for distributed systems cloud services and data platforms.

• You will drive premarket risk management deliverables including Software Hazard Analysis (SHA) design FMEA and risk controls related to cloud infrastructure data processing and AI/ML functionality.

• You will guide Software Design and Test teams on software design assurance activities such as requirements traceability software configuration management tool validation and integration of cloud and data services.

• You will review and approve software design control deliverables associated with cloudhosted services data pipelines and AI/ML components to ensure regulatory compliance and product quality.

• You will support postmarket activities related to software anomalies model behavior data quality issues risk assessments and CAPA activities as applicable.

• You will author review and maintain technical documentation including Design History Files SOPs protocols and reports for cloudbased and AI/MLenabled systems.

• You will assess change control activities related to infrastructure data or model changes to ensure no adverse impact to product performance and to maintain a compliant state.

• You will effectively communicate plans progress risks and design assurance considerations to crossfunctional teams and senior leadership.

What makes you successful:

Nice to have: AI/ML experience or ASQ CSQE certification.

• You bring strong experience in software design assurance for cloudbased data platform API and serviceoriented systems in a regulated environment.

• You have demonstrated handson knowledge of IEC 62304 FDA 21 CFR Part 820 ISO 13485 and their application to softwareasaservice and datadriven products.

• Your proficiency includes applying software design assurance principles across the SDLC including requirements analysis architecture and design reviews implementation oversight integration and verification.

• You have experience performing and reviewing software risk management activities including Software Hazard Analysis (SHA) design FMEA and change impact assessments for cloud data and AI/ML components.

• You are skilled at reviewing and approving software design control deliverables to ensure traceability risk control implementation and regulatory compliance.

• You have experience supporting software configuration management tool validation and integration of cloud services data pipelines and platform components.

• You communicate effectively with crossfunctional partners and can clearly present design assurance risk and compliance topics to technical teams and senior leadership.

What youll get: (this section should not be modified)

• 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:

• 5-15%

Experience and Education Requirements:

• Typically requires a Bachelors degreein a technical discipline and a minimumof 5-8 years related experience orMasters degree and 2-5 yearsequivalent industry experience or a PhDand 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. Dexcoms AAP may be viewed upon request by contacting Talent Acquisition at

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

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: 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.

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