Medical Device Software QA Engineer - Regulated Systems

Regulatory Jobs; United States; Remote; USD 79,000 - 132,000; Full time

Benefits offered by this job

Life-changing CGM technology

Comprehensive benefits

Global growth opportunities

Career development programs

Innovative organization

Job summary

Dexcom is seeking an experienced Software Quality Assurance Engineer to join the R&D QA team. You will ensure compliance with IEC 62304, 21 CFR 820, ISO 14971 and drive software validation across projects.

The role requires a technical degree and 2–5 years of related experience in software development or testing for medical devices, with strong SDLC knowledge and cross-functional collaboration across teams.

Qualifications

• Experience with software mobile applications in medical devices.
• FDA 21 CFR Part 820, IEC 62304, ISO 13485/14971 familiarity is preferred.
• Knowledge of SDLC and agile/waterfall processes.
• Software quality or engineering experience in requirements, design, integration and test.
• Ability to interpret software design and verify implementation.

Responsibilities

• Act as a core team member of the R&D Quality Assurance Engineering team.
• Provide guidance on IEC 62304, 21 CFR 820, ISO 14971 and other regulations to cross-functional teams.
• Lead application of policies and practices for software development and validation.
• Provide technical guidance on equipment, software, product and process requirements and risk management deliverables.
• Support system validations, traceability, configuration management and tool validation.
• Review, revise and approve design history files, SOPs, protocols and reports.
• Assess change control impact to maintain compliance and product performance.
• Communicate plans, status, and challenges to Dexcom management.

Skills

Software QA

Regulatory knowledge

SDLC

Agile

Waterfall

Requirements analysis

Design verification

Traceability

Software testing

Change control

Stakeholder communication

Cyber security

CSQE certification

Jama

Jira

TestRails

Kettryx

Education

Bachelor's degree in a technical discipline

Tools

Jama

Jira

Kettryx

TestRails

Job description

Dexcom is seeking an experienced Software Quality Assurance Engineer to join the R&D QA team. You will ensure compliance with IEC 62304, 21 CFR 820, ISO 14971 and drive software validation across projects.

The role requires a technical degree and 2–5 years of related experience in software development or testing for medical devices, with strong SDLC knowledge and cross-functional collaboration across teams.