ABOUT THE ROLE

The VP of Product Software will lead the product technology lifecycle and will be responsible for driving compliance and implementing the strategic vision for the regulated software products and services critical to Foresight’s mission. The VP of Product Software will partner with the PMO, Regulated Assay Development, Regulatory Affairs, Software Systems Engineering, Operations, and Quality leaders to develop and maintain regulated products in accordance with regulatory requirements and the software lifecycle. This is a complex role, encompassing technical leadership, regulatory compliance, risk management, and the overall quality and safety of the software throughout its entire lifecycle.
The ideal candidate will have a strong background of product software engineering in molecular diagnostics or the medical device industry, with extensive experience with FDA submissions and leading cross functional teams to deliver product software for medical device and SaMD meeting regulatory requirements and will have experience interacting directly with the FDA. This is a full-time position working standard business hours, but may require flexibility to work diverse schedules, including evenings, weekends, and holidays. This position reports to the Head of Product.

WHAT YOU WILL DO

• Responsible for ensuring cross functional teams supporting regulated product development execute to the software development lifecycle, including adherence to requirements management, design, development, testing and release.
• Collaborate with key cross functional teams such as Regulated Assay Development, Regulatory, 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, 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, notifying 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.
• Through proactive, strategic relationships with external stakeholders, stay at the forefront of advancements in bioinformatics and software for medical device development to drive innovation and to ensure all software validation activities comply with current medical device regulations and industry standards.
• Provide technical, strategic, and career guidance to the product technology team, fostering a culture of excellence and continuous learning.
• Act as a software subject-matter expert, representing the function in internal strategy discussions and external collaborations.
• Drive cross-functional initiatives, ensuring alignment with organizational goals, timelines, and regulatory requirements.