Remote Senior Software Quality Engineer - Medical Devices

React Health Holdings, LLC

United States

Remote

USD 120,000 - 190,000

Full time

2 days ago

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Job summary

React Health is seeking a Senior Software Design Quality Engineer to support development and sustaining of commercial software products. The role will focus on regulatory compliance, risk management, and quality assurance for multi-tenant, web-based platforms, with potential exposure to Class 2 or MDDS mobile apps.

The candidate will create and review software requirements, validation plans, and design controls, collaborating across engineering, logistics, and program management to ensure

Qualifications

7+ years of experience in medical device software design control.
Experience with ISO14971, 21CFR820, 21CFR11, MDDS, IEC62304, IEC60601 and related standards.
Ability to navigate regulatory aspects for multi-tenant, high-transaction software platforms.
Experience with patient-facing mobile apps supporting platforms that may be Class 2 or MDDS.

Responsibilities

Review and approve changes to commercialized software with respect to design risk management.
Apply statistics to support business decisions.
Conduct failure investigations and root cause analysis.
Develop and maintain project, quality, validation/verification, and software maintenance plans.
Collaborate with engineering, logistics, finance, and program management to define system requirements.

Skills

Regulatory software

Software validation

Risk management

Design verification

Mobile apps knowledge

Education

CS or EE degree

Job description

The candidate will create and review software requirements, validation plans, and design controls, collaborating across engineering, logistics, and program management to ensure

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