Remote Senior Software Quality Engineer, Medical Devices

React Health; Bothell (WA); Remote; USD 120,000 - 180,000; Full time

Job summary

React Health is seeking a Senior Software Design Quality Engineer to support development and sustaining of our medical software products.

You will lead design control, risk management, and verification/validation, ensuring compliance with ISO and CFR for web-based, multi-tenant platforms and patient-facing mobile apps. Collaboration with cross-functional teams is essential in this remote role.

Qualifications

• 7+ years experience in medical device software design control and regulatory standards (ISO14971, 21 CFR 820/11, 13485, IEC62304, IEC60601).
• Experience with software development, validation, and design changes for software products.
• Experience with software risk management file creation and updates.
• Ability to navigate regulatory software development for web-based, multi-tenant platforms.
• Experience with patient-facing mobile apps for Class 2 or MDDS.
• Create/review project plans, quality plans, validation/verification plans, and software maintenance plans.
• Create/review product requirements and software requirements.

Responsibilities

• Review and approve changes to currently commercialized product with design risk management.
• Applies statistics to make business decisions.
• Conduct failure investigations and root cause analysis.
• Collaborate with engineering, logistics, finance, and program management to define system specs.
• Attend meetings and training to maintain professional competence.
• Ensure department compliance guidelines are met.
• Attend all meetings and trainings as delegated by the supervisor.
• Provide customer-focused interactions.
• Perform other duties per department policies.

Skills

software design control

regulatory compliance

risk management

software validation

web-based platforms

mobile apps (MDDS/Class 2)

Education

Computer Science or Electrical Engineering degree

Job description

React Health is seeking a Senior Software Design Quality Engineer to support development and sustaining of our medical software products.

You will lead design control, risk management, and verification/validation, ensuring compliance with ISO and CFR for web-based, multi-tenant platforms and patient-facing mobile apps. Collaboration with cross-functional teams is essential in this remote role.