Software Quality Engineer

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🕒 Julho 27

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AppliedVR

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2015

🏥 Saúde

🥽 AR/VR

🔬 Ciência

💰 $36.000.000 Series B - AppliedVR em 2021-11

Healthcare • AR/VR • Science

A AppliedVR é uma empresa de saúde que desenvolve terapias imersivas de realidade virtual, combinando tecnologia imersiva com técnicas terapêuticas baseadas em evidências (como métodos cognitivo-comportamentais) para apoiar o alívio de sintomas e a recuperação acelerada. A empresa enfatiza a pesquisa clínica e o rigor científico, posicionando seus produtos como soluções de saúde imersivas validadas, e comercializa ofertas de marca como AVR Pathway, RelieVRx e SustainVR. O trabalho da AppliedVR se concentra em usar experiências de RV para melhorar o engajamento dos pacientes e o desenvolvimento de habilidades em contextos clínicos, em vez de puro entretenimento para o consumidor.

Descrição

• 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.

🎯 Requisitos

• 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

🏖️ Benefícios

• 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