Senior Software Design Assurance (Sr Software Design Quality) Engineer

Embedded Shishya; California (MO); On-site; USD 95,900 - 159,900; Full time

Benefits offered by this job

Comprehensive benefits

Global growth opportunities

Career development through in-house学习

Job summary

Dexcom, a leader in CGM technology, is hiring a Senior Software Design Assurance Engineer to guide regulatory compliance for cloud-based data platforms and AI-enabled systems. You will ensure conformance to IEC 62304, FDA 21 CFR Part 820, ISO 13485, and ISO 14971 while collaborating with cross-functional teams across software, regulatory, and analytics.

You’ll lead risk management deliverables, maintain design history files, and drive continuous improvement of software development and validation

Qualifications

• Bachelor’s degree in a technical discipline and 5–8 years of related experience (or Master’s with 2–5 years).
• Proven knowledge of IEC 62304, FDA 21 CFR Part 820, ISO 13485 and ISO 14971.
• Experience in software design assurance for cloud-based, data platform, API, and service-oriented systems.
• Ability to identify, analyze, and communicate risk and compliance topics to technical teams and leadership.
• Willingness to travel 5–15%.

Responsibilities

• Act as a core member of the R&D Quality Assurance Engineering team for cloud-based, data platform, and AI/ML-driven systems.
• Provide hands-on guidance on regulatory requirements for software-as-a-service and data products.
• Lead software design assurance practices across the SDLC, including requirements traceability and verification.
• Review design control deliverables to ensure regulatory compliance and product quality.
• Support post-market activities related to software issues and CAPA as applicable.
• Prepare and maintain DHFs, SOPs, protocols, and reports for cloud-based/AI systems.

Skills

Software design assurance

SDLC compliance

Cross-functional communication

Requirements traceability

Regulatory awareness

Education

Bachelor’s degree in technical discipline

Tools

IEC 62304

FDA 21 CFR Part 820

ISO 13485

ISO 14971

Job description

Headquarters: San Diego
URL: http://dexcom.com

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 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.

*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 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: (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 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 [e-mail].

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 [e-mail].

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

Salary:

$95,900.00 - $159,900.00