Software Quality Engineer

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AppliedVR

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2015

🏥 Healthcare

🥽 AR/VR

🔬 Science

💰 $36M Series B - AppliedVR on 2021-11

Healthcare • AR/VR • Science

AppliedVR is a healthcare company that develops immersive virtual-reality therapeutics combining immersive technology with evidence-based therapeutic techniques (such as cognitive behavioral methods) to support symptom relief and accelerated recovery. The company emphasizes clinical research and scientific rigor, positions its products as validated immersive healthcare solutions, and markets branded offerings such as AVR Pathway, RelieVRx, and SustainVR. AppliedVR's work focuses on using VR experiences to enhance patient engagement and skill-building in clinical contexts rather than purely consumer entertainment.

📋 Description

• 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

🏖️ Benefits

• medical/dental/vision healthcare benefits • 401k retirement plan with a 4% employer match • employer-paid life insurance and long-term disability benefits • employee assistance program • remote work stipend and car allowance (for field reps only) • Flexible Time Off for vacation • 11+ paid holidays per year • Sick time is accrued at one hour for every 30 hours worked. • Up to 12 weeks of paid parental leave for new parents