Software Quality Engineer

AppliedVR is unleashing the power of Immersive Therapeutics (ITx) to treat debilitating chronic conditions through innovative virtual reality medical devices. They are seeking a Software Quality Engineer to provide quality oversight, ensuring products are safe, effective, and compliant with regulations.

Responsibilities:

• Establish and maintain software quality assurance processes, and controls to ensure compliance with FDA regulations, IEC 62304, and established standards
• Act as the Quality partner across Product, Engineering, and SQE teams to drive consistent understanding, adoption, and adherence to QMS requirements from pre-market development through post-market release
• Support the design and development lifecycle deliverables to ensure compliance to existing procedures, and maintaining the Design History File (DHF/DDF), Medical Device File (MDF), and traceability matrices per FDA 21 CFR 820
• Lead risk management lifecycle activities, including authoring and maintaining Risk Management files and Hazard Analyses in accordance with ISO 14971
• Own CAPA investigations from root cause to timely, effective resolution
• Drive updates to procedures, work instructions, forms, and related systems to optimize business efficiency
• Support the implementation and continuous improvement of eQMS tools, including AI-enabled solutions and Model Context Protocol (MCP), to automate routine workflows and enhance data accessibility while maintaining regulatory compliance
• Manage the setup, maintenance, document routing, and approvals within the eQMS system to support team requests
• Support internal and external audits, including FDA inspections and Notified Body audits, and assist in preparing comprehensive responses to observations
• Support verification, validation, and electrical safety/EMC testing (per IEC 60601) to ensure product and QMS compliance, as needed
• Collaborate cross-functionally to investigate and resolve complaint-related software issues and drive corrective actions

Requirements:

• Bachelor's Degree in Electrical Engineering, Computer Engineering, or related technical discipline
• 5+ years of software product development experience within the healthcare, medical device, or digital health/digital therapeutics space; working knowledge of Agile methodologies is preferred
• Experience with medical device development under FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, and IEC 62304 strongly preferred
• Proven track record in risk management, CAPA ownership, and internal/external auditing processes
• Proven ability to author Verification/Validation (V&V) plans and reports, with knowledge of medical device electrical safety/EMC compliance testing (IEC 60601) and non-product computer system validation (CSV)
• Proficiency with Propel (or similar eQMS), JIRA, Confluence, and Google Workspace
• Knowledge of AI-powered productivity workflow automation and familiarity with MCP, APIs, and data integration
• A quality mindset; strong attention to detail, with a solution-driven mindset and a high degree of accountability
• Demonstrated ability to work cross-functionally and effectively communicate quality assurance requirements and expectations to non-quality stakeholders in a medical device work environment
• Excellent organizational and written/verbal communication skills
• Ability to work autonomously, remotely, in a dynamic, fast-paced environment