Senior, Software Design Quality Engineer

React Health Holdings•Bothell, WA

2d•Remote

About The Position

The Senior Software Design Quality Engineer supports the development and sustaining of commercialized software products at React Health, a manufacturer and distributor of medical equipment focused on respiratory and sleep health. The role applies medical-device design controls and regulatory requirements to software products, including web-based platforms and patient-facing mobile applications. It also supports product risk management, design changes, validation, and quality documentation.

Requirements

At least 7 years of experience, or equivalent experience, in medical-device software design controls.
Experience applying ISO 14971, 21 CFR 820, 21 CFR 11, MDDS, ISO 13485, IEC 62304, IEC 62366, IEC 60601, IEC 60812, and IEC 82304.
Experience with the development, validation, and design changes of software products.
Experience creating and updating risk management files for software products.
Ability to navigate regulatory requirements for web-based, multi-tenant, high-transaction compliance platforms for reusable equipment data transfer.
Experience with patient-facing mobile apps supporting the platform, which may be Class 2 or MDDS.
Excellent written and oral communication skills.
Ability to work effectively with diverse groups of people.
Normal visual acuity and hearing.

Nice To Haves

Degree in computer science or electrical engineering.
Experience with Design History File (DHF) remediation when moving from one design control system to another.
Experience with the European Medical Device Regulation (EUMDR).

Responsibilities

Review and approve changes to currently commercialized products with respect to product design risk management.
Apply statistical methods to support business decisions.
Conduct failure investigations and root cause analyses.
Use critical thinking to support business continuity and improve systems in lower-maturity processes.
Coordinate with engineering, logistics, financial, and program management disciplines to define system specifications and requirements.
Create, contribute to, and/or review project plans, quality plans, validation and verification plans, software development plans, and software maintenance plans.
Create, contribute to, and/or review product requirements and software requirements.
Attend and participate in departmental meetings, seminars, training sessions, in-service training, and continuing education as delegated or needed.
Ensure department compliance guidelines are met.
Provide customer-focused interactions and perform duties required by department policies and procedures.
Perform other duties and responsibilities delegated by the supervisor within the scope of practice and department responsibilities.