Sr SW Design Quality Assurance Engineer

Dexcom; Sacramento (CA); Hybrid; USD 96,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits package

Growth opportunities

Career development programs

Travel 5-15%

Job summary

Dexcom, Inc. is seeking a Sr Software Design Assurance Engineer to guide software teams in conformance with IEC 62304, ISO 13485, and FDA/regulatory standards for SaaS, data platforms, and AI-driven products.

You will lead SHA, design FMEA, and ensure traceability across SDLC while supporting post-market activities and cross-functional collaboration with R&D, Regulatory, and Cybersecurity teams.

Qualifications

• Experience with IEC 62304, FDA 21 CFR Part 820, ISO 13485 and their application to software-as-a-service and data-driven products.
• Strong experience in risk management activities including SHA and design FMEA.

Responsibilities

• Support software design assurance for cloud-based, data platform, and AI/ML-enabled systems.
• Interface with cross-functional teams across Software Engineering, Regulatory, Quality, and Leadership.
• Lead Software Hazard Analysis (SHA), design FMEA, and risk controls for cloud, data, and AI components.
• Review and approve software design control deliverables for traceability and regulatory compliance.
• Support post-market activities related to software anomalies and CAPA as applicable.
• Develop and maintain Design History Files, SOPs, and related regulatory documentation.

Skills

AI/ML experience

Regulatory compliance knowledge

Software design assurance

Cloud-based / SaaS experience

Communication to leadership

Education

Bachelor’s degree in technical discipline

Master’s degree in technical field

PhD in technical field

Job description

Job Description

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

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 cloud-based, data platform, and AI/ML-enabled systems.

You will provide hands-on technical guidance to cross-functional teams on IEC 62304, 21 CFR 820, and other applicable global regulations for software-as-a-service, data, and AI-driven 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 pre-market 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 cloud-hosted services, data pipelines, and AI/ML components to ensure regulatory compliance and product quality.

You will support post-market 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 cloud-based and AI/ML-enabled 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 cross-functional 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 cloud-based, data platform, API, and service-oriented systems in a regulated environment.You have demonstrated hands-on knowledge of IEC 62304, FDA 21 CFR Part 820, ISO 13485, and their application to software-as-a-service and data-driven 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 cross-functional partners and can clearly present design assurance, risk, and compliance topics to technical teams and senior leadership.

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:5-15%

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

Remote Workplace:

Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.

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 .

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: 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.

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Salary:$95,900.00 - $159,900.00#DexcomUS