Senior Medical Software Quality Engineer (Remote)

React Health; Bothell (WA); Remote; USD 110,000 - 160,000; Full time

Job summary

React Health is seeking a Senior Software Design Quality Engineer for a remote, full-time role. The position supports development and sustaining of commercialized software products, focusing on regulatory compliance and design controls across medical device software.

Ideal candidates bring extensive experience with ISO/IEC standards, risk management, and patient-facing mobile apps, contributing to project, quality, and software development plans while ensuring product integrity and compliance.

Qualifications

• 7+ years of experience in Medical Device Design control for software products.
• Experience with ISO14971, 21CFR820, 21CFR11, MDDS, ISO13485, IEC62304, IEC62366, IEC60601, IEC60812, and IEC 82304.
• Experience with risk management file creation and updates w.r.t. software products.
• Ability to navigate regulatory aspects of web-based, multi-tenant, high transaction platforms for reusable equipment data transfer.
• Experience with patient-facing mobile apps to support the above platform which may be Class 2 or MDDS.
• Create, contribute to the creation of, and/or review project plans, quality plans, validation/verification plans, software development plans, and/or software maintenance plans.
• Create, contribute to the creation of, and/or review product requirements and software requirements.

Responsibilities

• Review and approve changes to currently commercialized product w.r.t. design risk management.
• Applies statistics to make business decisions.
• Ability to conduct failure investigation and root cause analysis.
• Work in lower maturity processes using critical thought to provide pathways for business continuity and improve the systems.
• Coordinate with engineering, logistics, financial, and program management to define system specifications and requirements.
• Attend departmental meetings and training sessions to maintain competence.
• Ensure all department compliance guidelines are met.
• Attend meetings, in-services training, or continuing education as delegated by the supervisor.
• Provide customer focused interactions.
• Perform other duties as delegated by the supervisor within the scope of practice.

Skills

Design quality

Regulatory compliance

Risk management

Design control

Education

CS or EE degree

Job description

React Health is seeking a Senior Software Design Quality Engineer for a remote, full-time role. The position supports development and sustaining of commercialized software products, focusing on regulatory compliance and design controls across medical device software.

Ideal candidates bring extensive experience with ISO/IEC standards, risk management, and patient-facing mobile apps, contributing to project, quality, and software development plans while ensuring product integrity and compliance.