Senior Software QA Architect for Medical Devices (Consultant)

Regulatory Jobs

San Francisco (CA)

Hybrid

USD 120,000 - 170,000

Full time

12 days ago

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Job summary

Element Science, Inc. seeks a Senior Software Quality Assurance Engineer Consultant to support software verification and validation for life-saving medical device technology.

You will collaborate with Software, Systems, and Quality teams to develop test strategies, expand automation, and ensure compliance with design controls and regulatory requirements. The role emphasizes hands-on testing, debugging, and risk management for embedded software in a regulated environment, with opportunities to

Qualifications

  • Bachelor's degree in a technical discipline or equivalent experience.
  • Experience in software quality assurance, verification and validation, and test automation.
  • Experience documenting software defects and working in regulated medical device environments.

Responsibilities

  • Develop, review, and execute software test protocols aligned with product requirements and design specs.
  • Design, implement, and maintain automated tests for UI, API, and integration testing; troubleshoot environments and interfaces.
  • Prepare formal test reports and ensure traceability with design controls and risk management.

Skills

Software testing
Test automation
Embedded software
Regulated environment
Documentation

Education

Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or related field

Tools

Test automation frameworks
Scripting languages
Hardware interfacing

Job description

Element Science, Inc. seeks a Senior Software Quality Assurance Engineer Consultant to support software verification and validation for life-saving medical device technology.

You will collaborate with Software, Systems, and Quality teams to develop test strategies, expand automation, and ensure compliance with design controls and regulatory requirements. The role emphasizes hands-on testing, debugging, and risk management for embedded software in a regulated environment, with opportunities to

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