Vice President, Product Software

Summary

Join Foresight Diagnostics, a venture-backed molecular diagnostics company, as their Vice President of Product Software. Lead the product technology lifecycle, driving compliance and implementing the strategic vision for regulated software products. Partner with cross-functional teams (PMO, Regulated Assay Development, Regulatory Affairs, Software Systems Engineering, Operations, and Quality) to develop and maintain regulated products. This complex role demands technical leadership, regulatory compliance, risk management, and ensuring software quality and safety throughout its lifecycle. The ideal candidate will have extensive experience in medical device software, FDA submissions, and leading cross-functional teams. This full-time position offers flexibility in work schedule and reports to the Head of Product. The VP will manage the product software backlog, prioritize features, and stay at the forefront of bioinformatics and software advancements.

Requirements

• Bachelor’s or MS in 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, 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 with building software solutions secure against breaches, unauthorized access and cyberattacks, in compliance with HIPAA and relevant FDA guidance on cybersecurity
• 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
• Strong interpersonal and communication skills, with the ability to work effectively in a cross-functional team environment
• Successful history of coaching, mentoring, and providing feedback to support team members in their career growth
• Adaptable to fast-paced, dynamic work environments and shifting demands

Responsibilities

• 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

Benefits

• This role is hiring at a salary of $275,000 and is eligible for bonus and equity offerings
• Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match
• We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees