Senior, Software Design Quality Engineer

React Health Holdings, LLC•Bothell, WA

2h•$125,000 - $140,000•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 supports software products across acute care, non-acute care, and home medical equipment, including web-based platforms and patient-facing mobile applications. The position applies medical-device design controls, software quality and regulatory requirements, and risk management practices. It contributes to the planning, requirements, verification, validation, maintenance, and design-change activities for software products. The role also reviews changes to commercialized products, investigates failures, performs root-cause analysis, and works across engineering and other business disciplines to define system specifications and requirements. The role is remote. Its stated work environment is predominantly an office environment, with work in a research and development laboratory as required. The position involves extended computer use and typically sitting, with brief periods of standing, walking, bending, and carrying papers and books.

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 software product development, validation, and design changes.
Experience creating and updating software product risk management files.
Ability to navigate regulatory aspects of software development 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.

Nice To Haves

A degree in Computer Science or Electrical Engineering is preferred.
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

Support the development and sustaining of commercialized software products.
Review and approve changes to currently commercialized products with respect to product design risk management.
Apply statistics to support business decisions.
Conduct failure investigations and root-cause analysis.
Use critical thought to provide pathways for business continuity and improve systems in lower-maturity processes.
Coordinate and work closely 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.
Create and update risk management files for software products.
Attend and participate in departmental meetings.
Attend seminars and training sessions necessary to maintain an appropriate level of professional competence.
Ensure department compliance guidelines are met.
Attend meetings, in-service training, or continuing education as delegated by the supervisor.
Provide customer-focused interactions.
Perform duties required by department policies and procedures and other duties delegated by the supervisor within the scope of practice and departmental responsibilities.