Senior Software QA Engineer

• Support product development per the software development life cycle, including adherence to requirements management, design, and development.
• Collaborate with key cross functional teams such as assay development, regulatory affairs, software systems engineering, and quality to integrate bioinformatic and software innovations into diagnostic tools and workflows.
• Support the development and validation of algorithms and software solutions for medical device applications, ensuring compliance with regulatory and quality standards.
• Develop and implement comprehensive software validation strategies to include risk management, ensuring alignment with regulatory requirements (FDA, ISO, IVDR, etc.) and company standards in accordance with IEC 62304 Medical device software - Software life cycle processes.
• In collaboration with Software Systems Engineering leadership, oversee the creation and maintenance of system architecture and all validation documentation, including validation plans, protocols, test scripts, and reports to ensure compliance to regulatory standards.
• Collaborate with Software Systems Engineering, Regulatory, and Quality leadership to oversee software risk management activities, including hazard analysis and risk assessment.
• Maintain detailed documentation throughout the software lifecycle, including design specifications, test results, risk analyses and traceability records for compliance and audits.
• Partner with cross functional teams to prepare technical documentation, reports, and regulatory submissions such as 510(k) or PMA and participate in FDA interactions.
• Participate as a product software subject matter expert in routine interactions, product reviews, or audits with government authorities, notified bodies, or partners and co-lead resolution strategies to address gaps or issues raised.
• Manage the product software backlog, prioritizing features and enhancements based on the product roadmap, user needs, business value, and technical feasibility.
• Support development of Human Factors files, including planning of human factors testing and risk assessment in accordance with IEC 62366-1 and ISO 14971.

This position will be responsible for driving compliance and implementing strategic vision for the software products and services developed. The position will partner with the Product Management Organization, assay development, regulatory affairs, software systems engineering, operations, and quality for development and maintenance of products in accordance with regulatory requirements and the software development life cycle.

• This is a 6 month consultant role to be done remotely.

• The ideal candidate will have a strong background in product software engineering in molecular diagnostics or the medical device industry, with extensive experience with FDA submissions and working within cross functional teams to delivery product software for medical device and SaMD meeting regulatory requirements and will have experience interacting directly with the FDA., * Bachelor’s or MS in Software Engineering, Computer Science, or a related field.
• 10+ years of experience in the medical device industry with strong knowledge of software validation practices, quality systems, regulatory submissions, and compliance requirements for a medical device (e.g., ISO 13485, IEC 62304).
• Deep understanding of FDA regulations such as 21 CFR Part 820 to support design controls, quality management systems, production processes, and more. Familiar with relevant FDA guidance documents for medical device software and SaMD.
• Experience in compliance with HIPAA and relevant FDA guidance on cybersecurity, software risk controls, interoperability, change control, human factors.
• Experience implementing robust risk management processes and tools throughout the software development process, following standards like ISO 14971.
• Expert level experience with software validation and verification processes, including writing and executing test protocols and reports.
• Proven track record of working with regulatory bodies such as the FDA (e.g., 510(k), PMA, or Breakthrough Device Designation), to include direct interaction.
• Experience with planning and execution on Usability / Human Factors validation.
• Previous experience conducting or supporting ISO 13485 audits or supporting FDA inspections a plus.
• Strong interpersonal and communication skills, with the ability to work effectively in a cross-functional team environment.