Software Quality Engineer

Responsibilities

• Establish and maintain software quality assurance processes and controls for FDA and IEC 62304 compliance
• Act as a Quality partner across Product, Engineering, and SQE teams
• Support design and development lifecycle deliverables including DHF, MDF, and traceability matrices
• Lead risk management lifecycle activities and maintain Hazard Analyses per ISO 14971
• Own CAPA investigations from root cause to resolution
• Support implementation and improvement of eQMS tools and AI-enabled solutions
• Manage eQMS tool administration, including document routing and approvals
• Support internal and external audits, including FDA inspections
• Support verification, validation, and electrical safety/EMC testing
• Investigate and resolve complaint-related software issues

Requirements

• Bachelor’s Degree in Electrical Engineering, Computer Engineering, or related technical discipline
• 5+ years of software product development experience in healthcare, medical device, or digital health
• Experience with FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, and IEC 62304
• Proven track record in risk management, CAPA ownership, and auditing
• Ability to author V&V plans and reports
• Proficiency with Propel (or similar eQMS), JIRA, Confluence, and Google Workspace
• Knowledge of AI-powered workflow automation, MCP, and APIs
• Excellent organizational and communication skills

About the Company

AppliedVR is unleashing the power of Immersive Therapeutics (ITx), a new category of medical devices that harness the unique properties of virtual reality (VR) to treat chronic conditions. Their flagship product, RelieVRx®, is the first FDA-authorized VR device for chronic lower back pain.