Remote Software Design QA Engineer (Med Device)

Dexcom Inc.; San Diego, Northern (CA, KY); Hybrid; USD 79,000 - 132,000; Full time

Benefits offered by this job

Comprehensive benefits

Career development

Job summary

Dexcom Inc. in San Diego, CA is seeking a Software Design QA Engineer to support Software Design Assurance.

You will guide conformance to IEC 62304, 21 CFR 820, and related standards across software teams, participating in risk management, documentation, and change control activities. You will collaborate with cross-functional groups, drive design controls, support post-market activities, and contribute to continuous improvement in a fast-paced environment while ensuring the highest quality in

Qualifications

• Medical Device experience in compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485.
• Knowledge of SDLC processes and software development methodologies (Agile/Waterfall).
• Experience in Requirements Analysis, Design/Development, Product Integration and Test.

Responsibilities

• Lead pre-market risk management deliverables (SHA, design FMEA) and support cybersecurity risk management.
• Review and approve software design control deliverables and documentation.
• Support post-market activities related to software anomalies, risk assessments and CAPA.
• Lead R&D SW Design Assurance efforts and drive continuous improvement.
• Assess impact of changes to ensure continued compliance and traceability.

Skills

FDA 21 CFR Part 820

IEC 62304

SDLC

Agile/Waterfall

Software Quality

Communication to mgmt

Education

Bachelor’s degree in a technical discipline

2–5 years related experience or Master’s 0–2 years

Job description

Dexcom Inc. in San Diego, CA is seeking a Software Design QA Engineer to support Software Design Assurance.

You will guide conformance to IEC 62304, 21 CFR 820, and related standards across software teams, participating in risk management, documentation, and change control activities. You will collaborate with cross-functional groups, drive design controls, support post-market activities, and contribute to continuous improvement in a fast-paced environment while ensuring the highest quality in