Director, Software Engineering

Experteer Overview In this role you lead the software development for the FDA-cleared TruVerus platform, guiding software strategy, architecture, and lifecycle across instrument, application, cloud, and cybersecurity domains. You will ensure regulatory compliance and post-market support for a critical diagnostic product. You’ll shape a fast-paced, cross-functional team and partner with Quality, Regulatory, and other functions to deliver reliable, safe software. This is a mission-driven opportunity to accelerate point-of-care diagnostics. Compensation / Benefits * Define software strategy, roadmap, architecture, and release management for the diagnostic platform * Oversee regulated product development including design controls, verification & validation, and documentation * Support instrument control, assay execution, algorithm integration, cloud services, and customer-facing apps * Collaborate with Quality and Regulatory Affairs on FDA submissions, audits, and post-market support * Lead secure software development practices, vulnerability management, updates, and reliability * Build, mentor, and manage a high-performing software engineering team * Partner with cross-functional teams (Engineering, Operations, Manufacturing, Field Service, Regulatory) to optimize product performance and user experience Tasks * 10+ years in software engineering with 5+ years leading software teams * Direct experience with FDA-regulated medical device, IVD, diagnostic instrument, or point-of-care software * Experience with design control, software lifecycle, risk management, V&V, and quality systems * Strong understanding of IEC 62304 and regulated software development practices * Experience with cloud platforms (AWS, Azure, or Google Cloud) * Strong communication and cross-functional leadership in regulated environments Key requirements * Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K) * Flexible vacation * Onsite gym * Farm to table onsite restaurant with 30% discount * Kombucha and cold brew on tap * Craft coffee and healthy snacks

Lead secure software development practices, vulnerability management, updates, and reliability * Build, mentor, and manage a high-performing software engineering team * Partner with cross-functional teams (Engineering, Operations, Manufacturing, Field Service, Regulatory) to optimize product performance and user experience Tasks * 10+ years in software engineering with 5+ years leading software teams * Direct experience with FDA-regulated medical device, IVD, diagnostic instrument, or point-of-care software * Experience with design control, software lifecycle, risk management, V&V, and quality systems * Strong understanding of IEC 62304 and regulated software development practices * Experience with cloud platforms (AWS, Azure, or Google Cloud) * Strong communication and cross-functional leadership in regulated environments Key requirements * Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K) * Flexible vacation * Onsite gym * Farm to table onsite restaurant with 30% discount * Kombucha and cold brew on tap * Craft coffee and healthy snacks