Remote Senior Software Design Quality Engineer

React Health; Washington; Remote; USD 130,000 - 190,000; Full time

Job summary

React Health is seeking a Senior Software Design Quality Engineer to support development and sustaining of our commercial software product. The role is remote and full-time, focused on ensuring design controls, risk management, and regulatory compliance for medical software across web-based platforms and patient-facing mobile apps.

The ideal candidate brings 7+ years in medical device software design control, familiarity with ISO/IEC regulations, and experience creating and reviewing quality and

Qualifications

• 7+ years of experience in medical device software design control.
• Experience with ISO14971, 21 CFR 820/11, 21 CFR 11, MDDS, ISO13485, IEC62304, IEC62366, IEC60601, IEC60812, and IEC82304.
• Experience with risk management for software products.
• Navigate regulatory aspects of software development for web-based, multi-tenant platforms for reusable equipment data transfer.
• Experience with patient-facing mobile apps to support the platform (Class 2 or MDDS).
• Create, contribute to, or review project plans, quality plans, validation/verification plans, software development plans, and software maintenance plans.
• Create, contribute to, or review product requirements and software requirements.

Responsibilities

• Review and approve changes to currently commercialized product w.r.t. design risk management.
• Apply statistics to inform business decisions.
• Conduct failure investigation and root cause analysis.
• Work in lower maturity processes using critical thinking to improve systems.
• Coordinate with engineering, logistics, financial, and program management to define system specifications.
• Attend departmental meetings and seminars to maintain professional competence.
• Ensure compliance with department guidelines and policies.
• Provide customer-focused interactions and support.
• Perform other duties as delegated by supervisor within department scope.

Skills

Software Quality

Medical Device Software

Regulatory Compliance

Risk Management

Design Control

Validation & Verification

Cross-functional Collaboration

Education

Bachelor's degree in Computer Science or Electrical Engineering

Job description

React Health is seeking a Senior Software Design Quality Engineer to support development and sustaining of our commercial software product. The role is remote and full-time, focused on ensuring design controls, risk management, and regulatory compliance for medical software across web-based platforms and patient-facing mobile apps.

The ideal candidate brings 7+ years in medical device software design control, familiarity with ISO/IEC regulations, and experience creating and reviewing quality and