Systems QA Engineer

About This Role

This Systems QA Engineer role supports R&D teams by leading software requirements definition, risk management, and verification & validation activities for an on-market diagnostic software product.

Responsibilities

• Lead software requirements definition for an on-market diagnostic software product
• Lead risk management (FMEA) for an on-market diagnostic software product
• Lead verification & validation activities for an on-market diagnostic software product
• Own requirements delivery for new features
• Assess and document associated risks
• Update quality system documentation accordingly
• Partner cross-functionally with engineering, quality, product, and other stakeholders to facilitate decision-making and tradeoff analysis

Requirements

• Bachelor’s degree in engineering, Biomedical Sciences, or related technical field
• 3-5+ years of experience in software/systems requirements, risk analysis, or quality engineering
• Strong software requirements writing experience
• Hands-on risk analysis (FMEA) experience within an engineering discipline
• Demonstrated knowledge of systems engineering principles including requirements engineering, risk management, configuration management, tradeoff analysis, and verification & validation
• Ability to work cross-functionally and communicate effectively with diverse stakeholders

Qualifications

• Bachelor’s degree in engineering, Biomedical Sciences, or related technical field
• 3-5+ years of experience in software/systems requirements, risk analysis, or quality engineering

Nice to Have

• Experience in a regulated industry
• Medical device experience
• Experience with RETINA
• Experience with LucidSpark/LucidChart
• Assay development experience, particularly with cytology specimens
• Experience in an Agile or SAFe Agile planning environment
• Exposure to Azure DevOps or Jira

Skills

* Required skills